Category Archives: Biotech

Innovative Drug Discovery Business, Biosortia Pharmaceuticals, Lands Two Health Care Veterans

Kurt Dieck formerly SVP of Strategy and Business Execution at Cardinal Health, will lead early stage drug discovery business at Biosortia Pharmaceuticals. Dieck was named President and CEO in November 2012 and has quickly identified other key executives, including Dr. Guy Carter, former Natural Product head at Wyeth Pharmaceuticals, as his Chief Science Officer. In conjunction, other collaboration partners have joined the team, including NOAA (National Oceanic and Atmospheric Administration), NCI (National Cancer Institute) and key universities, to strategically accelerate the development of novel drug leads in the therapeutic areas of cancer, infectious diseases, inflammation and neurological disorders. Biosortia Pharmaceuticals has seen promising early results with dozens of novel compounds having already been requested, and are under evaluation with NCI and Eli Lilly.

Dieck has spent nearly 30 years in healthcare, including 18 years at Arthur Andersen as a global equity partner and then 10 years with Cardinal Health, a Fortune 20 public company, as a senior executive; there he worked with a broad spectrum of partners, including brand pharmaceutical manufacturers, throughout the supply chain. Dr. Guy Carter has over 30 years of experience working in pharmaceutical R&D, primarily in the discovery and development of microbial natural products. He previously was the leader of natural products drug discovery at Wyeth Research, as head of the Chemical Technologies Department.

“Kurt and Guy make a great team. Their complementary Pharma experiences and backgrounds create great opportunities to accelerate Biosortia’s objective to become the premier, aquatic natural products company with a primary focus in drug discovery,” says Ross Youngs, Biosortia’s Founder and Chairman. “Kurt and Guy bring a wealth of research and business experience along with deep industry relationships in building successful Pharma partnerships. Everyone involved with this young biotech is excited about the future.”

Industry observers have commented that late-stage R&D pipelines are not providing Pharma with the desired revenue growth the market is expecting. Therefore, large Pharma is evolving the way it performs R&D in order to optimize efficiency and to boost patent cliff defenses. These changes require shifting from relying solely on in-house chemistry-based R&D to acquiring and licensing external technologies and natural products based compounds in various stages of development. Biosortia’s ability to supply novel, highly active and potent compounds with drug-like characteristics will increase the productivity and success rate for Pharma as well as reduce the overall cost of the discovery process. The cost to discover, develop and launch a new drug is estimated to reach nearly $3B per drug by 2015. Biosortia’s business model is designed specifically to support Pharma’s needs.

“With nearly unlimited microorganisms (3.7 nonillion), the aquatic environment and its consortia represent an extraordinary opportunity…a new frontier, to access extremely potent and chemically diverse secondary metabolites with drug-like properties with unique mechanisms of action never researched before,” said Dieck. In describing the opportunity, Dieck goes on to say, “Biosortia is on the cutting edge of natural product discovery
and has the capabilities to deliver on its aspiration. Our powerful natural products research team, led by Dr. Guy Carter, in partnership with NOAA’s Dr. Peter Moeller, a leader in aquatic natural products research, has the experience and know-how to decipher the complex unexplored environment in a very efficient manner leveraging all the current state of the art instrumentation. The need for more efficient and effective approaches to drug discovery has never been more important. Biosortia’s innovative technologies, deep research skills and key relationships will efficiently provide thousands of unique natural products as candidates for drug discovery at a time when Pharma is in critical need for “high quality shots on goal.”

“Aquatic microbial consortia are a rich source of metabolically active organisms including microalgae, bacteria, fungi and their secondary metabolites,” states Carter. “Owing to the competitive nature of their habitat, chemical investigations of microbial consortia reveal unique structurally diversified natural products that are responsible for signaling and self-defense that have potential as therapeutics with novel mechanisms of action. Since they have been pre-optimized by nature, these compounds are typically closer to a drug candidate than a synthetic lead, thus requiring less optimization and shorter time when found as ‘hits’ in screening programs.”

The team has also focused on agreements with strategic collaboration partners as vital components to the strategy. Biosortia has recently entered into several collaboration agreements with NOAA, Analyticon and exclusive harvesting relationships, just to name a few. Several others will be advanced by the end of January. Biosortia’s cooperative research and development agreement (CRADA) with NOAA’s Center for Human Health Risk at Hollings Marine Laboratory provides a 5-year framework for research and development regarding the analysis and purification of novel bioactive compounds. According to NOAA’s Technology Partnerships Office, “Success will result in the commercial development of new and unique chemical compounds from the sea which have benefits to human health, either through disease prevention or new treatments for disease.”

Dr. Peter Moeller, NOAA’s Research Scientist who leads the Toxins Natural Products Program stated after analyzing fractions of Biosortia’s biomass, “Coupling NOAA’s mission of characterizing toxins affecting environmental and/or human health with Biosortia’s drug discovery focus turns one man’s toxin into another’s chemotherapeutic. The microorganisms analyzed in the Biosortia biomass identified more unique activity than I have seen in my 30 year career. The volumes achieved from a single harvest delivered an equivalent of 30 years of accumulation. This could materially change the landscape for natural products drug discovery research.”

As of December 31, 2012, Biosortia has identified more than 30 bioactive candidate compounds (hits) from a fresh water eutrophic lake consortium. Therapeutic areas of focus include treatments for cancer, infectious diseases, inflammation and neurological disorders. In addition, more than a dozen of its patent protected compounds are in initial evaluation stage within Eli Lilly’s Open Innovation Drug Discovery Program.

Dieck states, “Looking forward, it is with great optimism. We have a great team built around mutual respect, deep experience, and a desire to succeed and make a difference. We are aligning with the right partners and collaborators to execute our strategy with speed and discipline to provide Pharma with much high quality & diverse compounds vs. “me-too” drugs than they have had in the past 10 years. We are excited about what this company can accomplish, not only for its shareholders but also for the millions of people who have been diagnosed with various forms of chronic diseases who are looking for Pharma to identify better ways to help them extend their lives or live a more productive life. Biosortia can play a big role in identifying compounds that can help Pharma achieve these goals. I am looking forward to the challenge and opportunity to build an industry leading drug discovery company.”

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Microtissues® Inc. and Sigma-Aldrich® Sign Worldwide Supply and Distribution Agreement for the 3D Petri Dish®

Microtissues® Inc. announced today the signing of a Supply and Distribution Agreement with Sigma-Aldrich® Corporation (Nasdaq: SIAL) for the worldwide sales and marketing of the 3D Petri Dish®, a new technology for the culture of living cells in three dimensions (3D). Invented at Brown University, the 3D Petri Dish® maximizes cell-to-cell interactions critical for replicating the function of natural tissues and organs. Shown in numerous peer reviewed papers to work with over fifty different cell types, including cell lines, primary cells and stem cells, the 3D Petri Dish® has applications in cancer research, drug discovery, toxicity testing and regenerative medicine.

“Researchers are rapidly recognizing the importance of 3D cell culture and its ability to reliably mimic in vivo function” said Brian Morgan, Director of Business Development, Microtissues® Inc. “The 3D Petri Dish® creates a natural 3D environment without artificial scaffolds and we’re excited that this distribution agreement will bring our unique and innovative line of products to the worldwide research community.”

Unlike the conventional plastic Petri dish where cells are grown as a thin layer on the surface of the dish, the 3D Petri Dish® forms 3D aggregates of cells. Spheroid size is controlled by the number of cells seeded and hundreds of uniform sized spheroids are formed in a single pipetting step. Spheroids are formed in a well ordered array in a stable platform suitable for long term culture. All spheroids are positioned on the same optical plane making them easy to image (phase contrast, fluorescent). Spheroid size is controlled by the number of cells seeded and a mixture of cells forms mixed spheroids, suitable for investigating tumor-stroma interactions. Spheroids can be grown from single cells, applicable to the study of cancer stem cells. For histology, Western blots and RT-PCR, spheroids are harvested by simply inverting the 3D Petri Dish®. No need to dissolve or digest the gel. The 3D Petri Dish® is a new fundamental tool for the world wide industry of life sciences research.

About Sigma-Aldrich®: Sigma-Aldrich® is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich® customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich® is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich®, please visit its website at www.sigma-aldrich.com.

About Microtissues® Inc: Microtissues® Inc. is a privately held company located in Providence, RI, advancing technologies and applications of 3D cell culture. Microtissues®, Inc.’s products are designed to serve the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. Microtissues®, Inc. has an exclusive worldwide license from Brown University to US and international patent applications on the 3D Petri Dish®. For more information on Microtissues®, Inc., please visit www.microtissues.com.

Sigma-Aldrich and Sigma are trademarks of Sigma-Aldrich Co. LLC registered in the US and other countries. Microtissues and 3D Petri Dish are registered trademarks of Microtissues, Inc.

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Is it a Moment or an Abuse: the Boom of iPSCs Research after 2012 Medicine Nobel Prize

On Creative Biomart website, we can read a report about the 2012 Nobel Prize in Physiology or Medicine regarding the two winners. They bring hope for organ or tissue repair for human or even for rejuvenation, i.e. for long life through induced pluripotent stem cells (iPSCs).

Since the first appearance in 2006, iPSCs became the hit and focus. But there are still lots of unknowns waiting for us before achieving the ideal status. Thus, numerous scientists, researchers and businessmen are struggling and investing for that goal. Here are some examples:

On Dec. 5, 2012, Roche (SIX: RO, ROG; OTCQX: RHHBY) and the Innovative Medicines Initiative (IMI) announced today the launch of StemBANCC, a new academic–industry partnership that unites ten pharmaceutical companies and 23 academic institutions. Initiated and coordinated by Roche and managed by Oxford University, StemBANCC aims to use human induced pluripotent stem cells as research tools for drug discovery with the goal of using this ground-breaking new technology to develop human disease models and enhance drug development.

On Oct. 29, 2012, on the PANS Journal there is an article about Cartilage tissue engineering using differentiated and purified induced pluripotent stem cells.

On Oct. 4, 2012, on Cell Stem Cell, there is a report with the title be Genome Sequencing of Mouse Induced Pluripotent Stem Cells Reveals Retroelement Stability and Infrequent DNA Rearrangement during Reprogramming.

On Jan. 30, 2012, on the PANS Journal, there is a report about modeling hepatitis C virus infection using human induced pluripotent stem cells, which make the individual and tailor therapy further.

Above are only a small part of such studies. People still wonder does it is the moment or an abuse on the iPSCs research. When someone reviewed one of the winners, Shinya Yamanaka, about his opinion on the challenge of iPSCs research, he said, “I have two research directions, the first is to establish human iPSCs bank that comply with clinical application standards. The second is to study the cell mechanism of iPSCs regenerating. And I think the current threat is still to be the safety problem as good research respects both scientific and ethical standards.”

But no one deny the great potential of iPSCs.

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Sprint Bioscience Strengthens Its Cancer Metabolism Portfolio

Sprint Bioscience, a Swedish company developing oncology therapeutics targeting cancer metabolism, announced today that it has raised money to strengthen its drug discovery portfolio.

The investment by Första Entreprenörsfonden and Almi Invest will enable the company to continue to build a pipeline of drug discovery projects within cancer metabolism.

“We are investing in Sprint Bioscience because we consider their entrepreneurial drive and their particular skills in drug development to be key success factors for the changing environment of the future pharmaceutical industry. Sprint Bioscience’s business strategy involves out-licensing or collaborating at an early stage of drug discovery to ensure that projects are developed with a focus on current and relevant market needs,” says Rune Nordlander, partner at Första Entreprenörsfonden.

Sprint Bioscience is a company founded by experienced drug hunters with an ambition to improve the drug discovery process. “We believe in small organisations with effective working procedures and collaborations throughout the sector,” says the company’s CEO and co-founder, Dr. Anders Ã…berg.

“Sprint Bioscience has developed an efficient, fragment-based drug discovery (FBDD) platform that can take parallel projects from initial idea to active molecules tested in cell-based systems in a very short time” Anders Ã…berg continues. Our goal is to align the early phase in the laboratory with pharmaceutical companies’ needs.

Targeting the metabolism in tumours provides exciting opportunities to develop drug therapies with novel mechanisms of action. This could be used to overcome the resistance that many cancer cells develop to current treatments.

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Stem Cell Treatment Give CMT Patient Second Chance At Life!

“Pat receive a life altering Stem Cell Treatment with the help of World Stem Cells, LLC. Pat went from couch bound to walking 1.5 miles on country dirt road, climbing stairs, gardening and playing piano all thanks to a stem cell treatment.”

Pat is a 69-year-old woman with Charcot-Marie-Tooth disease, or CMT. She had been experiencing the effects of CMT for more than thirty years, and her progressive motor sensory neuropathy had become severe enough to interfere with every aspect of her life. She could no longer play piano, balance well enough to climb up steps or get dressed easily or summon the energy to work for more than a couple of hours before taking a rest break. Pat’s form of CMT is CMT1A, which is the most common form of this autosomal dominant condition. Her symptoms were typical of CMT; patients typically endure progressive muscle wasting and weakness in the legs, and a later loss of hand strength, balance, coordination and fine motor skills.

Pat’s neurological disorder is hereditary, and the official position of the National Institute of Neurological Disorders and Stroke is that CMT has no cure. Decades ago, Pat had gone to a neurologist for electromyography, or EMG. The purpose of the procedure was to evaluate her muscle function, and it involved painful needles and days of muscle soreness after each session. Pat’s neurologist had refused to tell her the results because he said that she would “just give up” if she knew how bad they were. At this point, Pat’s symptoms were so crippling and unbearable that she contacted World Stem Cells, LLC worldstemcells.com to explore stem cell treatment as an option. She knew that the procedures were still being developed and experimental, and that they came with no guarantees. She remained interested in learning more and becoming educated on the options presented. At the time, she was unable to walk without a four-leg quad cane, and air and car travel were exhausting and caused unbearable pain. Pat has a long history of surgeries and was told that further surgeries would not assist her. She decided that she was not interested in any treatment that involved surgery with incisions, which is an aggressive approach and would demand recovery time. Stem cell therapy met her requirements of being minimally uncomfortable, requiring only hours for recovery and having a high level of safety, along with a good potential for changing her health quotient for the better.

Pat arrived in Cancun, Mexico, to the treatment site of World Stem Cells, LLC contract clinics, doctors, and hospitals. The first day, she met with physician Dr. Sylvia M. Abblitt to be evaluated, discuss her course of treatment and learn what to expect. She had been corresponding with Dr. Alan Kadish, the President of World Stem Cells, LLC. worldstemcells.com

Dr. Kadish is an unusual physician as he has training and practiced integrated primary care medicine combining conventional and naturopathic diagnostics and therapeutics for 27 years. He has been recognized as one of the leading quality physicians, in his field. Dr. Kadish is an American Board of Anti-Aging Medicine diplomat and completed numerous training programs in Achieving Clinical Excellence, or ACE, which provided opportunities to improve his practical skills in diagnosing and treating people based on their individual needs, using functional medical testing and treatment. He has been an advanced level practitioner (Autistic Research Institute) for autistic spectral disorder children and adults, since early 2000 and is certified in chelation therapy. As a naturopathic medical physician he lecturers frequently and is a host and guest on radio and internet outlets along with appearing in a number of print media publications. At World Stem Cells , LLC in addition to his management duties, he is a primary investigator engaged in research and designs of stem cell therapeutic protocols.

In Cancun, Pat met with specialists at Advanced Cellular Medicine Clinic. The clinic is headed by Dr. Sylvia Abblitt, who has the exclusive distinction of being among the few physicians who are licensed to perform autologous and allogeneic stem cell transplants in Mexico. Dr. Abblitt is a board-certified hematologist and oncologist. She has 11 years of expertise as a laboratory director and head of the hematology department at the Fernando Quiroz Hospital. She is a member of the American Association of Blood Banks and the International Cellular Medicine Society (ICMS).

The Cancun clinic that Pat visited is a contract clinic of World Stem Cells, LLC. It houses the state-of-the-art Advanced Cellular Engineering Lab. The high-tech lab is suited for providing patients with the most up to date stem cell treatments and for conducting stem cell research to improve future opportunities for health.

After her evaluation and discussion of treatment options, Pat decided to go ahead with the stem cell therapy. The procedure involved a needle puncture to harvest her bone marrow utilizing her own stem cells. Only a local anesthesia was necessary and though she described the procedure as “uncomfortable,” she added that it was“livable.” The procedure took less than half an hour, and she experienced no side effects.

Pat’s improvement was remarkable and rapid. In fact, she did not feel fatigued and overwhelmed with pain, as she had in the past, when she traveled back home from Cancun by airplane and car. Within days, she had regained her ability to play piano. Playing at church concerts had always been a passion of hers, but she had been unable to play before her stem cell treatment because of a lack of coordination. She had much more energy after treatment, and was able to garden, run errands and work, without feeling exhausted. Her sleep was more restful. Her husband and friends noticed that her agility and balance were better. She could climb up and down stairs more easily and walk around the house without clutching the walls. Her speed on the treadmill was increasing gradually and she now walks a mile and a half on country roads.

Pat is extremely grateful to World Stem Cells, LLC for changing her life and giving her hope. For the first time, she has reversed many of the negative changes that she had been experiencing for years due to her CMT and lack of effective treatment. Now, Pat and her husband are experiencing a bright future and thankful that Pat was given this second opportunity, following stem cell therapy.

Working under the guidelines set forth by international cellular medical society (ICMS) World Stem Cells, LLC provides Stem Cell Treatment for Ankylosing Spondylitis, Autism, Cerebral Palsy, Charcot-Marie-Tooth Disease (CMT), Crohn’s Diseases, COPD, Fuch’s disease, Guillain-Barre’ Syndrome, Hashimoto’s Thryroiditis, ITP, Kidney Diseases, Macular Degeneration, Lupus (SLE), Multiple Sclerosis, PAD, Parkinson’s disease, Rheumatoid Arthritis, Scleroderma, Stroke, Ulcerative Colitis at its contract Clinics, GLP laboratory, doctors and hospitals in the beautiful resort area of Cancun. We endeavor to provide the best care possible at a mediate price while providing documentation of all treatments that can be used to provide better future care and scientific data to the medical industry.

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Great Ormond Street Hospital Supports Stem Cell Awareness Day

Great Ormond Street Hospital and its research partner, The Institute of Child Health at University College London (UCL), are supporting Stem Cell Awareness Day, with UCL promoting the event with the launch of a new YouTube video featuring Mr Paolo de Coppi and his colleagues.

Mr. de Coppi is Clinical Senior Lecturer in the Surgery Unit at The Institute of Child Health at UCL and carries out stem cell research at Great Ormond Street Hospital. It is hoped the research will result in stem cells being used to repair damaged organs. Mr de Coppi has looked for naturally occurring stem cells in amniotic fluid as a novel solution to some of the serious birth defects he sees. Around 40 per cent of patients at Great Ormond Street Hospital have some form of birth defect.

Mr de Coppi said: “As a surgeon I often see the devastating effects of multiple reconstructive operations aimed at replacing damaged organs. I have therefore focused my research interests on stem cells and tissue engineering, trying to find new ways to treat complex birth defects. I have identified stem cells in the amniotic fluid and found they have the ability to become many different types of cell. Our research aims to find ways of using these cells to repair and replace damaged tissues, so that babies are given the chance of a healthy life from the day they are born.

“The idea is we can create tissues in a test tube using a baby’s own cells, and then implant these at birth. We’re looking at repairing organs like intestines or windpipes. Grown from a child’s own cells, there should be no rejection of tissue.”

The video sees Mr. de Coppi discussing the work he and his colleagues carry out and offering insight into the latest developments relating to his stem cell research and the possibility of deriving cells from amniotic fluid. The full video can be viewed here: http://www.youtube.com/watch?v=qD_V1hqR6SI.

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Great Ormond Street Hospital Patients Take Part In Duchenne Muscular Dystrophy Clinical Trial

Great Ormond Street Hospital has announced that a team led by scientists at its research partner, UCL Institute of Child Health (ICH), funded by the Medical Research Council (MRC) and AVI BioPharma, have made an important breakthrough in the development of a treatment for Duchenne Muscular Dystrophy (DMD).

Together with the MDEX Consortium, chaired by the ICH’s Professor Francesco Muntoni, the group showed that a gene based drug treatment was effective in restoring the dystrophin protein, missing in sufferers of DMD in seven out of 19 trial participants.

The results of the clinical trial will be published in The Lancet, a world leading general medical journal.

DMD is a devastating and life limiting condition, affecting one in 3,500 male births in the general population, with around 100 cases diagnosed in the UK each year.

Three of the participants in the higher dose cohort showed dystrophin levels exceeding 18 per cent of those found in normal muscle.

Thirteen per cent of boys with DMD could be treated with this specific ‘antisense’ gene therapy, the largest group by a single antisense. Overall, scientists say this approach could work for at least 70 per cent of DMD sufferers.

DMD causes progressive muscle weakness due to the breakdown and loss of muscle cells. Patients lack a single important protein in their muscle fibres called dystrophin. By ages eight to 12 years boys become unable to walk, and by their late teens or early twenties the condition can become severe enough to limit life expectancy.

In this clinical trial of 19 patients, study participants aged five to 15 at Great Ormond Street Hospital and the Royal Victoria Infirmary, Newcastle, were given weekly doses of the drug, AVI-4658. The drug had already been tested for safety and efficacy by the MDEX Consortium and AVI Biopharma in an earlier phase of the study.

Francesco Muntoni, professor of paediatric neurology at the ICH, said: “These are very exciting results that prove the case for an even more detailed look at this genetic therapy. I’ve worked with patients with DMD for many years and this is the first time we can say with confidence that we’ve made a significant breakthrough towards finding a targeted treatment.

“Importantly, the study drug was extremely well tolerated, with no appreciable side effects detected during the study period in any of the boys. If our strategy shows continued success, this therapy could substantially reduce muscle damage in affected boys with DMD, improve the quality of life for DMD patients, their mobility and the way their condition is managed as they get older.”

Professor Max Parmar, director of the MRC Clinical Trials Unit, said: “A large proportion of new drugs do not make it past the phase II stage of testing reached here, so there is real excitement that this treatment could work.

Brothers Jack, 11, and Tom, 8 were enrolled on the trial. Both have DMD with a deletion from 45-50. Their mum, Claire, said: “Jack and Tom were placed on a DMD genetic registry, co-ordinated by Action Duchenne, which is how we were approached about the clinical trial at Great Ormond Street Hospital.

“The boys were on the trial for 12 weeks between 2009 and 2010. Our whole family noticed a marked difference in both of their quality of life and mobility over that period. We feel that it helped prolong Jack’s mobility and that Tom has been considerably less fatigued.”

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Ardeo Healthâ„¢ Licenses New Dry Eye Therapy From Novagali Pharma

Ardeo Health, LLC, a biopharmaceutical development and licensing company, announced today that it has reached an agreement with Novagali Pharma S.A. of Evry, France to license Novagali’s novel Nova23041 dry eye therapy for sale in the United States and Canada. The product will be marketed and distributed as Retaine® MGD™ Ophthalmic Emulsion under a brand license from OCuSOFT®, Inc., of Richmond, TX, USA. OCuSOFT, Inc. will also serve as the exclusive distributor under a multiyear agreement between Ardeo and OCuSOFT. Retaine MGD will target those individuals suffering from Meibomian Gland Dysfunction (MGD) and Evaporative Dry Eye.

Retaine MGD will be a preservative-free oil-in-water emulsion resulting from Novagali’s patented Novasorb® technology whose efficiency and tolerance in treating dry eyesymptoms have been proven during a number of clinical trials carried out in Europe and Southeast Asia. Successfully marketed since 2008 under the brand name Cationorm®, a brand that belongs to Novagali Pharma, the product is already recommended by ophthalmologists in numerous countries throughout Europe, North Africa, the Middle East, and Southeast Asia.

Based on the electrostatic attraction between the positively charged Nova23041 eye drop and the negatively charged corneal epithelium of the ocular surface, Novasorb’s technological platform enables the product to be spread in an optimal, uniform and comfortable way across the entire ocular surface, improves retention time and thus reduces the number of drops required each day by MGD and dry eye sufferers due to its increased efficiency and optimal compliance and tolerance.

“Everyone at Ardeo Health is excited to see this newest technology brought to North America. Patients suffering from moderate to severe Dry Eye will now have an alternative to expensive prescription (Rx) therapies”, states Robert “Bob” Sykora, RPh, President & CEO of Ardeo Health. “With these partnerships, Ardeo has the best of both worlds—the science of Novagali coupled with the brand recognition and distribution channels of OCuSOFT”.

Cynthia Barratt, President of OCuSOFT comments, “OCuSOFT has been searching for a truly unique proprietary Dry Eye therapy which also combined a long-term partnership—and we have found that with Ardeo Health and Novagali. I believe Retaine® MGD™ will become the standard of care for those suffering with Meibomian Gland deficiencies and Evaporative Dry Eye symptoms”.

Jérôme Martinez, Chairman of Novagali Pharma, concludes: “We are very pleased to be able to announce, today, the signing of this agreement involving two major American ophthalmology players. Given their proven expertise on the North American ophthalmology market, the Ardeo and OCuSOFT teams will no doubt make Nova23041’s launch in the United States and Canada a success that will enable us to extend the distribution of our unique formulation for treating dry eye symptoms around the world. This agreement confirms the growing reputation of the products and technologies developed by Novagali Pharma in the United States.”

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Enabling microRNA Discoveries – 250th Peer-Reviewed Publication Made Possible By µparaflo Custom Microarray Technology

LC Sciences, a life sciences company leading the development of innovative microRNA (miRNA) analysis and discovery technologies, announced today the publication of over 250 peer-reviewed studies using the company’s microarray service for analyzing miRNA expression profiles. These studies, by leading researchers in the field, represent significant steps toward realizing these small regulatory RNA’s potential as biomarkers and therapeutic targets.

MiRNAs have proven to be an extremely important part of the gene expression regulation mechanism of a wide variety of cellular processes. This is evident in the amount of relevant findings by LC Sciences’ customers being translated into published reports and the diverse range of study areas that these publications encompass: cancer research, neuroscience, cardiovascular research, reproductive biology, plant science, microbiology, immunology and stem cell research. LC Sciences’ miRNA profiling service, powered by its µParaflo® custom microarray technology, provides quick, reliable, fully analyzed datasets enabling researchers to immediately move forward with groundbreaking research.

The miRNA field is still nascent, and it is advancing rapidly. The race to discovery has produced a continuous stream of new miRNA sequences as well as routine revisions of inaccurate or incomplete sequences. This fluidity has caused many microarrays with static content to fall away and has fueled reports of the wholesale replacement of microarrays by new methods such as RNA-Seq. But the nimble, customizable format of the µParaflo® array has given it staying power, not only by enabling it to keep current with all known miRNAs, but also by making use of data generated by RNA-Seq. These custom arrays have benefited from RNA-sequencing generating novel content that other arrays are unable to capture and take advantage of.

The 250th study, entitled “Wolbachia uses host microRNAs to manipulate host gene expression and facilitate colonization of the dengue vector Aedes aegypti.” appeared in the May 31st issue of PNAS and was one of a group of articles published recently by LC Sciences’ customers describing microarray expression analysis of miRNAs recently discovered through RNA Sequencing.

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New Report on Fighting Chronic Disease Examines the Importance of Non-Communicable Diseases in Global Health Care

In the first of a series of new reports, a coalition of pharmaceutical industry trade organizations outlines the serious burden that chronic diseases place on patients and global health care systems.“Fighting Chronic Disease: Importance of Non-communicable Diseases” is the first of four reports that look at this growing issue for patients and health care systems around the world.

The report was compiled by the European Federation of the Pharmaceutical Industries and Associations, the International Federation of Pharmaceutical Manufacturers & Associations, the Japan Pharmaceutical Manufacturers Association, and the Pharmaceutical Researchers and Manufacturers Association. Together, these organizations highlight the powerful role that public-private partnerships can play in mitigating the burden of chronic disease. Non-communicable diseases like stroke, heart disease, diabetes, and cancers can often strain global health care resources, and targeting the main risk factors of these conditions can significantly reduce the burden of these diseases worldwide.

Most NCDs are preventable because they are caused by modifiable risk factors, which include poor diet, lack of physical activity and tobacco use. Every year, more than 5 million people die because of direct tobacco use and 2.8 million die from being overweight or obese. High cholesterol accounts for 2.6 million deaths and 7.5 million die because of elevated blood pressure. Individually, chronic disease lowers quality of life for those affected, causes premature deaths and negatively impacts the economic solvency of families, communities and nations. Interventions that focus on better diet, increased physical activity and access to vaccines have been proven to decrease the incidence of chronic disease and improve quality of life.

The pharmaceutical industry has long recognized the economic and social burden of non-communicable diseases (NCDs) and has been working with governments, health care providers, patients groups and other stakeholders as an active solution partner in lessening this burden. The industry promotes and supports health prevention and promotion strategies and patient-centered approaches to managing chronic conditions and their risk factors. At the same time the global biopharmaceutical industry leads the search for new cures and the research and development of new medicines to treat or prevent non-communicable diseases. There are currently thousands of medicines either in clinical trials or awaiting approval to treat NCDs. The great challenge in preventing and controlling NCDs on a global scale is finding patient-centered solutions that reduce the burden on global health care services by promoting individual healthy lifestyles.

The R&D-based pharmaceutical industry works to improve the health and quality of life of all patients, and is committed to continuing partnerships that tackle these complex issues including extensive investment in R&D programs dedicated to the development of new NCD preventative and treatment products. Both prevention and treatment play an important role in addressing the problem of non-communicable diseases.

The full report is available at
http://globalhealthprogress.org/mediacenter/index.php/new-report-examines…

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Will the Catholic Church & the U.S. Courts Embrace Advanced Cell Technologies “Embryo-Safe” Technique Using Embryonic Stem Cells?

Advanced Cell Technology with laboratory facilities in Marlborough Massachusetts has pioneered a solution to the ethical, moral & legal debate raging in regards to protection of a human embryo. ACT has developed the “single-blastomere” technique. Patent Number 7,893,315 a non-destructive alternative for deriving human embryonic stem cell (hESC) lines.

This achievement in Regenerative medicine is a ground breaking feat for both Catholic and U.S. law.
• The 1995 encyclical The Gospel of Life, of which Pope John Paul II wrote: “Human embryos obtained in vitro are human beings and are subjects with rights; their dignity and right to life must be respected from the first moment of their existence. It is immoral to produce human embryos destined to be exploited as disposable ‘biological material'” (1,5 )
• The Dickey Amendment (also known as the Dickey-Wicker Amendment) is the name of an appropriation bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton, which prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.

The single-blastomere technology uses a one-cell biopsy approach similar to pre-implantation genetic diagnosis (PGD), which is widely used in the in vitro fertilization (IVF) process and does not interfere with the embryo’s developmental potential. The stem cells generated using this approach are healthy, completely normal, and differentiate into all the cell types of the human The safety record for one-cell biopsy as part of PGD now has a 15-year track record, and is carried out routinely as part of IVF processes around the world. ACT’s technique of protecting the human embryo from harm can be expounded to the smallest blood transfusion in the world. As does a human being give millions of blood cells in a pint of blood so does ACT’s “single blastomere” process take but “one cell” from a 2 day old embryo. As the blood removed from a human donor “regenerate” the removed pint of blood so does the human embryo “regenerate” the one cell. Both of these procedures leave the human body & two day old embryo healthy. Both procedures are similar in that they both provide life saving material to those whom need them most to due to disease and other aliments of a medical nature.

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Global Health Progress Releases Non-Communicable Diseases Partnerships and Programs List

Global Health Progress compiled a list of non-communicable disease treatment programs from around the world, highlighting partnerships to address cancer treatment, diabetes care, epilepsy programs and more. The programs, sponsored by leading companies like Astra Zeneca, Abbott, Novo Nordisk, and Bayer Healthcare, aim to increase awareness of non-communicable diseases in the developing world.

“Our goal in creating this list is to bring awareness to these companies who work so hard at fighting diseases in developing countries,” explains Mark Grayson, Vice President of Communications and Public Affairs at PhRMA and key developer in the Global Health Progress initiative. “Non-communicable diseases are the leading killer in many of these countries, and without the help of these programs they would continue to increase.”

Global Health Progress works with partner groups to encourage and sustain funding for the research and development of healthcare in developing nations. Improving health care systems and access to medicines, especially in the developing world, requires multifaceted approaches and solutions. Research-based biopharmaceutical companies are active partners in some of the largest and boldest health initiatives that explore new and effective ways to provide treatment, care and education to millions of people in developing countries.

Read the full list of non-communicable disease treatment programs here:
http://globalhealthprogress.org/mediacenter/wp-content/uploads/NCD-Health-Partnerships-and-Programs_Worldwide-05-02-11.pdf.

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Side by side comparison of Advanced Cell Technology & Geron Corporation

Regenerative medicine is a highly complicated and vastly misunderstood science. Investor Stem Cell is dedicated to bringing investors and stakeholders together in thoughtful discussion to educate and publicize the incredible advancements unfolding in the regenerative medicine sector. A quantum leap in health care is upon the world. Will you profit from this emerging sector & help bring cures to millions? Find out now what the street thinks at www.investorstemcell.com.

Side by side comparison of Advanced Cell Technology & Geron Corporation:

Geron Corporation (NASDAQ:GERN), Approved by the FDA to use human embryonic stem cell (hESC) treatments to treat spinal cord injuries. The research Goliath is a well-funded machine employing the top minds in the world working on everything from mid-stage oncology trials to promising (hESC) drugs for spinal cord injuries, heart disease & cancer.

Snap shot of Goliath: Geron Corpoartion-(NASDAQ:GERN)-
• Seven oncology Phase 2 trials currently underway, and has several big Pharma joint venture agreements in oncology animal and human trials
• Five hESC areas of investigation underway. GRNOPC1 is the lead candidate. Geron destroys the human embryo through its (hESC) R&D, of which the company uses the blastocyst embryo formation at day five after fertilization from IVF clinics
• Cash, restricted cash, cash equivalents and marketable securities: $221,274.000.00
• Total operating expenses in 2010: $114,730,000.00
• 175 employees; over 100 hold PhD or MD degrees
• Geron Corporation was founded in 1990 and is based in Menlo Park, California
• Trades on the NASDAQ providing liquidity & large institutional investors
• Corporate financial statements:http://www.geron.com/investors/reports/GeronAnnualReport2010.pdf

Advanced Cell Technology not too long ago was the predominant leader in the field of regenerative medicine. It fell from that distinction in part due to executive management hubris and ultimately the credit crisis in mid-2008. ACT was able to resurrect itself from near bankruptcy in June 2008 and now has the distinction of holding two out of the three FDA approved (hESC) trials. ACT is led by a competent executive management team and employs several of the most predominant regenerative researcher(s) in the world.

Snap shot of David: Advanced Cell Technology-(OTC:ACTC)-
• Retinal Pigment Epithelial Cell Program is their lead program-(HESC) trials for both SMD/AMD are expected to start in week(s) Jules Stein Eye Institute at the University of California, Los Angeles (UCLA ) will conduct the 2 (hESC) trials for Stargardt’s Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (AMD)
• Filed a European Clinical Trial Application for Phase 1/2 study using (hESC) to treat macular degeneration
• Issued a broad patent for hESC-derived RPE cells in China
• Seeking funding & joint venture partner for Myoblast program for the treatment of cardiovascular disease Phase 2 approved by the FDA
• Joint ventured with Korean medical giant CHA to form “Stem Cell & Regenerative Medicine International” (SCRMI). This partnership expected to file an investigational new drug application (IND) with the FDA in Q-4 of this year. CHA biotech is waiting for final approval from the Korea Food and Drug Administration for (hESC) trial for AMD
• Issued patent on its “single-blastomere” technique. Patent Number 7,893,315 broadly covers ACT’s proprietary single-blastomere technology that provides a non-destructive alternative for deriving hESC lines. This “Embryo-Safe” one-cell biopsy approach similar to pre-implantation genetic diagnosis (PGD), which is widely used in the in vitro fertilization (IVF) process and does not interfere with the embryo’s developmental potential
• 22 full-time employees, six hold PhD or MD degrees-Formed in 1994, HQ in Menlo Park, California with laboratory facilities in Marlborough, MA
• Total operating expenses in 2010: $22,044,701
• Cash, restricted cash, cash equivalents and marketable securities: $34,889,409
• Trades on the OTC:BB ACTC is a Sarbanes–Oxley Act SEC reporter
• Corporate financial statements: http://www.sec.gov/Archives/edgar/data/11...

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From Universal HIV Testing to HIV Cure

People involved in the fight against HIV/AIDS will gather in Marseille, France, May 23-25, 2012 for an international AIDS Conference under the theme: ‘From Universal HIV Testing to HIV Cure’.

The ISHEID (International Symposium on HIV & Emerging Infectious Diseases) is a major scientific event attracting doctors, biologists, researchers, patients’ representatives and policy makers from all around the world. Its next edition, to be held just more than one year ahead, will focus on recent developments against this pandemic.

Despite major advances in antiretroviral therapy, HIV still infects daily 2,000 new individuals and kills 2 millions each year. Current treatments are life-long with problems of compliance, resistance, toxicity, access, and cost.

‘There are advances both in the area of prevention, testing and potential cure’ told Alain Lafeuillade, a French Doctor involved in the organization of the conference. ‘Our driving force is to draw to the conference the best experts in the world for each program theme’. Antiretroviral treatment as prevention (or pre-exposure prophylaxis) will be debated with the pros and cons. Human rights and access to HIV care will be the focus of en entire session. Current issues in antiretroviral therapy management will be discussed during 2 sessions. Finally, the best American experts in the field of HIV reservoirs and eradication research will present their latest discoveries in the search for a cure.

The international Steering Committee will actively build a program the most exciting possible in the forthcoming months. Meanwhile, interviews of renowned experts are regularly published on the meeting website: http://www.isheid.com/en/committees/interview.html

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New Website Dedicated To Stem Cell Investors

Investor Stem Cell (http://www.investorstemcell.com) is dedicated to bringing investors and stakeholders together in thoughtful discussion to educate and publicize the incredible medical advancements taking place in the regenerative medicine sector. Scientists are using stem cells both (hESC) and (iPSC) in hopes of easing the suffering of hundreds of millions of people world wide.

Our society is on the verge of a quantum leap moment in time thanks to regenerative medicine.

Regenerative medicine and Stem Cell research:

Utter those words at your next dinner party or casual gathering of friends and family. You will receive a concoction of half-truth’s and out right fallacy responses. Stem Cell research conjures images of futuristic Star–Trek like preservation chambers, human looking ears protruding oddly from the backs of mice, or worse yet an image of a late term fetus. Nothing could be farther from the truth when entering the reality of Regenerative medicine.

Never before has this area of research been more exciting and promising than right now. There is a medical revolution brewing, and like any revolution, there are those who want to suppress this uprising for continued personal and ideological gains. If we were to take all the major advances in the past 500 years of human medical history and multiply its effect by 10 fold it still would not compare to the paradigm shift in health care delivery that the world may witness in this decade using stem cells. Imagine that an $800,000 heart transplant is no longer needed and that instead the same money spent on one patient can now be stretched out to treat 20 patients who are needing a heart transplant. Is this what Regenerative medicine has in the offing? Only time will tell. Our healthcare system could very well be on the verge of a quantum leap moment thanks to regenerative medicine.

The Food and Drug Administration (FDA) authorized 3 trials using human embryonic stem cells (hESC) in late 2010. Validation of hESC research efforts and the culmination of billions spent on research are coming to fruition. FDA validation for the treatments of spinal cord injury and age related macular degeneration is expected in 2011. It may be the shot heard around the world event sometime in late Q-4 2011 for the Regenerative medicine sector.

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Medical Innovation Protection Stressed in EU-India Free Trade Agreement Talks

The Financial Express published an article on the Free Trade Agreement (FTA) talks that continue between the European Union (EU) and India. One of the most discussed and disagreed upon parts of the proposed FTA involves the need for protecting the intellectual property of pharmaceutical companies in order to promote medical innovation and investment in the development of new medicines and research. This disagreement about whether data exclusivity in the pharmaceutical sector should be included has resulted in the delay of finalizing the FTA.

Pharmaceutical companies rely on data exclusivity to protect the investment made in developing the medication that is used throughout the world. Millions of dollars are spent on clinical trials to prove the safety and effectiveness of these drugs. These exclusive rights prevent competitors from obtaining marketing licenses for lower cost versions of these drugs.

Global Health Progress (GHP) is committed to being part of the effort to create a sustainable health care system that includes improving access to health care and continuing medical innovation and progress for all people. While the pharma industry is divided on the issue, GHP supports efforts to improve regulations protecting pharmaceutical companies’ intellectual property. Without this protection, the funding of studies that bring these medications to market could suffer.

Improving health care systems and access to medicines, especially in the developing world, requires multifaceted approaches and solutions. Research-based biopharmaceutical companies are active partners in some of the largest and boldest health initiatives that explore new and effective ways to provide treatment, care and education to millions of people in developing countries.

About Global Health Progress:
Global Health Progress also supports efforts to raise awareness and mobilize resources to address health challenges in the developing world by bringing local leaders together with international health experts, policymakers, donor governments, and the private sector.

www.globalhealthprogress.org;

twitter.com/globalhealth;

facebook.com/pages/Global-Health-Progress/124850684219049;

linkedin.com/groups?home=&gid=2972068

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Global Health Progress Amplifies Report Calling for Funding Products to Fight Neglected Tropical Diseases

The third-annual Global Funding of Innovation for Neglected Diseases (G-FINDER) survey was released last week revealing both good and bad news for the funding of neglected diseases in the developing world. In a press release issued by Policy Cures, an independent group providing research and analysis for those involved in the creation of new pharmaceuticals for neglected diseases, the group reveals that while funding for neglected diseases has increased, funding for new products has decreased.

Funders appear to be focusing more of their money toward traditional basic research. This shift has caused a $50 million drop in funding for Product Development Partnerships (PDP), non-profit organizations that partner with external organizations to drive product development for neglected diseases, including neglected tropical diseases.

Report author Dr Mary Moran, Director of Policy Cures warns funders not to “take their eyes off the ball” in the press release, stating that while the increase in funding is encouraging it is important that the funds are spent wisely.

Global Health Progress has worked with partner groups to encourage and sustain funding for the research and development of new products. The innovative research and development (R&D) of new drugs and vaccines is a critical component of improving health care and combating epidemics of neglected tropical diseases in developing countries. There are no vaccines or cures for some widespread and life threatening diseases such as malaria, while existing treatments for diseases such as tuberculosis are becoming less effective due to drug resistance.

Read the full press release from Policy Cures here:
http://globalhealthprogress.org/mediacenter/wp-content/uploads/G-FINDER_Year_3_media_release.pdf,
or read the G-FINDER report on the Policy Cures website:
http://www.policycures.org/downloads/g-finder_2010.pdf.

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Global Health Progress Encourages Global Partnerships on Access to Health Care

Starting this month, members of Congress will be looking closely at U.S. spending as they work with the White House to build the 2012 budget. One area that has come under increased scrutiny is U.S. spending on global health programs. Several groups last week announced a petition (http://www.supportglobalhealth.org/) seeking support for global health spending through the United States Global Health Initiative. Many fear that even flat spending in this area could jeopardize important programs in vaccine research and treatment.

News like this highlights the important role that public-private partnerships play in supporting access to global health care. The Global Health Progress initiative seeks to bring research-based biopharmaceutical companies and global health leaders together to improve access to medicine and health care in the developing world. We are committed to being part of the effort to create a sustainable health care system that includes improving access to health care and continuing medical innovation and progress for all people.

Research-based biopharmaceutical companies and their partners around the world are working to implement sustainable solutions and strengthen the health care delivery systems so they can meet tomorrow’s challenges. Millions of people lack access to essential medicines due to factors including incomplete delivery systems, lack of training for health personnel, lack of infrastructure and the cost of treatments. We must address the underlying barriers to health care, such as weak and fragmented health systems, limited health care personnel and inadequate resources for scaling up proven solutions. The innovative research and development (R&D) of new drugs and vaccines is a critical component of improving health care and combating epidemics in developing countries.

Through meaningful public-private partnerships with others in the field, including policymakers in the developed and developing world, multi-lateral institutions, non-governmental organizations, and academia we can help shape sustainable solutions that improve the health of all people.

To stay informed on the latest news about global investment in pharmaceutical R&D and improving access to medicines, sign up to receive special alerts and newsletters. You can also spread the word about the efforts of the Global Health Progress initiative and keep others informed about how we’re affecting change around the world, or share your story about how you or someone you know is working to promote global health.

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Assay-Ready Chemistry Partnership between Molplex & Enamine

Molplex and Enamine today announced a new partnership to offer the Enamine screening collection of 1.8 million stock chemicals through the Molplex online drug design and assay-ready chemical supply services. The agreement is a major step towards eliminating the high start-up costs ofdrug discovery, bringing sophisticated drug design, compound management and assay-ready chemistry to the world’s drug discovery scientists on demand.

The agreement adds Molplex online drug design systems to the deep experience in organic chemistry and compound management of Enamine to solve the problem of generating viable chemical leads for novel targets.

Molplex CEO David E. Leahy said: “We are very proud to be selected by Enamine as their partner for on demand drug discovery services at a time when major restructuring of the industry is creating new opportunities and new markets for our combined expertise. This agreement marks a step change in the size and scope of our assay-ready chemical supply service and major progress towards our goal of being the world’s first choice partner for enabling the long tail of drug discovery”

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Gene Therapy and Stem Cell Therapy Standard Developed For A Unique Derivative Of Post Hetero-Plastic Inplantation Chronic Inflammation Syndrome, The NIDO Disease

Researchers task force, led by faculties of T-Protocol, registered Genom Project as controlled genom project in the hosted database of NCBI, a publication matter authority and function assigned organization under oversee of Department of Health & Human Services, reached once to share the exegetical impression officially pre-published concerning the understanding specific spectrum of symptoms covering boroad range of character usually complained and observed through chronic inflammation, granuloma, some types of lymphoma and various uncommon symptoms to let physician scientists suspecting indicium of neurological diseases, NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome and setting Massachusetts indications of treatments standardized manual (Massachusetts manual) & diagnostic and standardized medical treatment manual for post hetero-plastic inplantation chronic inflammation syndrome, specific edition against NIDO Disease.

The once defined causes of NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome are considered each of a common living organism to cause conformational diseases like Creutzfeldt-Jakob disease, Alzheimer’s disease, Parkinson’s disease, Huntington’s disease and kinds of and a set of biochemical and physical reaction and response realized by cross-species gene- mutation, as biotransformation, easily describing natural physiological and biochemical changes in vivo substrate of human bodies. After this studies, standardized protocol of gene therapy and applied stem cell therapy is now in practice and on available.

Faculties,committing themselves entirely to the project, of each institutes and organizations participating the project to ascertain proteins and DNA/genomic DNA/genom of human, other mammal and virulent microorganism including bacillus/virus affecting each symptom and the symptoms’ spectrum expressed generally and observed commonly on patients suffered from NIDO disease, extraordinarily unique derived type of post hetero-plastic implantation chronic inflammation syndrome and to develop diagnostic standard and treatment protocol standardized and to find a clue compose gene therapy protocol and applied stem cell therapy protocol to entirely heal NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome and to let all of current suffered patients from various combined symptoms directly derived by chronic inflammation and various tumors, have to express full surprise at the fact that these disease and patients suffered are made up and left no attention and no relief.

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