28-06-2012 13:54 About 5 months ago, she came home from the beach with my husband limping on her right back leg. Now 8 weeks later after stem cell therapy... we were happy (well, maybe not so much...) to see her back to her old, wild, hyper self again.
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Ipo 8 weeks after stem cell therapy at Surf Paws Animal Hospital - Video
SAN DIEGO CA--(Marketwire -06/29/12)- Medistem Inc. (MEDS) announced today notice of allowance from the United States Patent and Trademark Office (USPTO) for a patent covering the use of fat stem cells, and cells associated with fat stem cells for treatment of diseases related to a dysfunctional immune system. Such diseases include multiple sclerosis, Type 1 diabetes, rheumatoid arthritis and lupus. The allowed patent, entitled "Stem Cell Mediated Treg Activation/Expansion for Therapeutic Immune Modulation" has the earliest priority date of December 2006.
"We have previously published that giving multiple sclerosis patients cells extracted from their own fat tissue, which contains stem cells, appears to confer clinical benefit in a pilot study," said Thomas Ichim, CEO of Medistem. "The current patent that has been allowed, in the broadest interpretation of the claims, gives us exclusive rights to the use of specific types of fat stem cell therapy for autoimmune diseases such as multiple sclerosis."
Subsequent to the filing of the patent application, Medistem together with collaborators at the Lawson Health Sciences Research Institute, Canada, reported data that fat tissue contains high numbers of T regulatory cells, a type of immune cell that is capable of controlling autoimmunity.
This finding was independently confirmed by Dr. Diane Mathis' laboratory at Harvard University, who published a paper in the prestigious journal, Nature Medicine, in which detailed experimental evidence was provided supporting the initial finding that adipose tissue contains high numbers of T regulatory cells. A video describing the paper can be accessed at http://www.youtube.com/watch?v=rEJfGu29Rg8.
The current patent discloses the use of T regulatory cells from fat, combinations with stem cells, and use of fat-derived mononuclear cells. Given that there are currently several groups utilizing this technology in the USA in treating patients, Medistem believes revenue can be generated through enforcement of patent rights.
"Our corporate philosophy has been to remain highly focused on our ongoing clinical stage programs using Medistem's universal donor stem cell, the Endometrial Regenerative Cell (ERC), in the treatment of critical limb ischemia and congestive heart failure," said Dr. Vladimir Bogin, Chairman and President of Medistem. "However, due to the ease of implementation of our fat stem cell technology, combined with the major burden that autoimmune diseases have on our health care system, we are highly incentivized to explore partnering, co-development and licensing opportunities."
Autoimmune conditions occur as a result of the body's immune system "turning on itself" and attacking its own organs or cells. Current treatments for autoimmune conditions are based on "globally" suppressing the immune system by administration of immunosuppressive drugs. This is associated with an increased predisposition to infections and significant side effects. The utilization of stem cells and T regulatory cells offers the potential to selectively suppress pathological immunity while preserving the ability of the body to fight bacteria and viruses. According to the NIH there are approximately 23 million victims of autoimmune conditions.
Links to Documents:
Link to peer-reviewed publication: http://www.translational-medicine.com/content/pdf/1479-5876-7-29.pdf
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Medistem Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases
COLUMBIA, Md.--(BUSINESS WIRE)--
Osiris Therapeutics, Inc. (OSIR), announced today the expansion of its intellectual property protection around Prochymal (remestemcel-L). The United States Patent and Trademark Office recently granted Osiris two patents that cover multiple mechanisms of action related to cardiac tissue repair. Additionally, Osiris has enhanced its mesenchymal stem cell (MSC) patent estate with the issuance of patents across Europe and Australia covering stem cells expressing all therapeutically useful levels of cell surface receptors for TNF-alpha, a receptor essential to the cell's ability to counteract inflammation. These patents further support Osiris' considerable intellectual property position, which includes 48 issued U.S. patents around the production, composition, testing and use of the mesenchymal stem cell from both allogeneic and autologous sources.
"These recent additions to Osiris patent estate, combined with the existing broad coverage of our pioneering MSC platform technology, reinforce our industry leading IP portfolio and bolster our dominant position regarding the manufacture and use of mesenchymal stem cells for the treatment of a broad range of diseases, said Chris Alder, Chief Intellectual Property Counsel of Osiris. We have invested significant time and resources building our intellectual property estate, and with the commercialization of Prochymal, we are preparing to take the necessary action to enforce our considerable rights.
Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program. With Prochymal (remestemcel-L) entering commerce, Osiris has initiated the process of identifying entities that may be infringing upon its intellectual property rights and will take appropriate action as necessary.
About Prochymal (remestemcel-L)
Prochymal is the worlds first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial for refractory Crohns disease and is also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having developed the worlds first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix for burns and chronic wounds, and Ovation for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign patents.
Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIRG)
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Osiris Bolsters its Stem Cell Intellectual Property Estate
Neuralstem, the Rockville company thats developing a stem cell treatment for patients with amyotrophic lateral sclerosis, has begun testing the safety of its treatment for major depressive disorder.
The compound, NSI-189, stimulates new neuron growth in the brain's hippocampus region, which scientists think is involved in depression and other conditions, including Alzheimer's disease, anxiety and post-traumatic stress disorder, according to a company statement. The phase 1b study involves 24 depressed patients and is expected to run six months.
"We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source," Karl Johe, Neuralstem's chief scientific officer, said in the statement.
The company has researched hippocampal stem cell lines since 2000 and in 2009 won U.S. patents for four chemical entities that generate new neurons. In studies, NSI-189 stimulated such growth in mice.
In other Maryland bioscience industry news:
Supernus Pharmaceuticals has received tentative marketing approval from the Food and Drug Administration for its once-daily, extended release version of an epilepsy treatment.
The FDA said it has completed its review of Trokendi XR and no more clinical trials are required. Final approval hinges on resolving a marketing exclusivity issue that involves a specific pediatric population, according to the FDA's letter to Supernus.
Trokendi XR is an extended-release version of topimarate, which is marketed as Topamax by Janssen Pharmaceuticals of Titusville, N.J., to treat seizures and migraine headaches.
"We will continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval," CEO Jack Khattar said in the statement.
Supernus, which went public this year, also said the FDA denied a petition filed in 2011 by Upsher Smith Laboratories related to its Trokendi XR application.
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Gazette.Net: Rockville biotech tests stem cells for depression
Public release date: 28-Jun-2012 [ | E-mail | Share ]
Contact: Nicole White nicole.white@cshs.org 310-423-5215 Cedars-Sinai Medical Center
LOS ANGELES (EMBARGOED UNTIL NOON EDT ON JUNE 28, 2012) Cedars-Sinai scientists have joined with expert colleagues around the globe in using stem cells to develop a laboratory model for Huntington's disease, allowing researchers for the first time to test directly on human cells potential treatments for this fatal, inherited disorder.
As explained in a paper published June 28 on the Cell Stem Cell website and scheduled for print in the journal's Aug. 3 issue, scientists at Cedars-Sinai's Regenerative Medicine Institute and the University of Wisconsin took skin cells from patients with Huntington's disease and reprogrammed them into powerful stem cells; these were then made into the nervous system cells affected by the disease. Seven laboratories around the world collaborated to demonstrate the cells had hallmarks of Huntington's.
"This Huntington's 'disease in a dish' will enable us for the first time to test therapies on human Huntington's disease neurons," said Clive Svendsen, PhD, director of the Cedars-Sinai Regenerative Medicine Institute and a senior author of the study. "In addition to increasing our understanding of this disorder and offering a new pathway to identifying treatments, this study is remarkable because of the extensive interactions between a large group of scientists focused on developing this model. It's a new way of doing trailblazing science."
The Huntington's Disease iPSC Consortium united some of the world's top scientists working on this disease. Cedars-Sinai researchers took skin cells from a several Huntington's patients, including a six-year-old with a severe juvenile form of the disease. They genetically reprogrammed these tissues into induced pluripotent stem cells, which can be made into any type of cell in the body. The cells lines were banked by scientists at Cedars-Sinai and scrutinized by all consortium members for differences that may have led to the disease. These cell lines are now an important resource for Huntington's researchers and have been made available via a National Institutes of Health-funded repository at Coriell Institute for Medical Research in New Jersey.
Huntington's, known to the public, for example, as the cause of folksinger Woody Guthrie's death, typically strikes patients in midlife. It causes jerky, twitching motions, loss of muscle control, psychiatric disorders and dementia; the disease ultimately is fatal. In rare, severe cases, the disorder appears in childhood.
Researchers believe that Huntington's results from a mutation in the huntintin gene, leading to production of an abnormal protein and ultimately cell death in specific areas of the brain that control movement and cognition. There is no cure for Huntington's, nor therapies to slow its progression.
The consortium showed Huntington's cell deficits or how they differ from normal cells, including that they were less likely to survive cultivation in the petri dish. Scientists tried depriving them of a growth factor present around normal cells, or "stressing" them, and found that Huntington's neurons died even faster.
"It was great that these characteristics were seen not only in our laboratory, but by all of the consortium members using different techniques," said Virginia Mattis, a post-doctoral scientist at the Cedars-Sinai Regenerative Medicine Institute and one of the lead authors of the study. "It was very reassuring and significantly strengthens the value of this study."
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Cedars-Sinai researchers, with stem cells and global colleagues, develop Huntingtons research tool
SHREWSBURY, Mass.The stem cell bank at the University of Massachusetts is set to run out of cash and close at the end of this year.
State and university officials tell The Boston Globe (http://bo.st/LQi71Z ) that changes in technology and federal policies around stem cell research have made obsolete the facility at the U-Mass Medical Center's Shrewsbury campus.
The stem cell bank was established in 2008 with the help of $8.6 million state funding, part of Gov. Deval Patrick's effort to boost the life sciences industry in Massachusetts. Human stem cells were kept and distributed to researchers working on potential cures for diseases and spinal cord injuries.
Experts say new technologies for producing stem cells and the loosening of federal restrictions on research have significantly altered the need for facilities like the one at U-Mass.
Information from: The Boston Globe, http://www.boston.com/globe
Copyright 2012 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Stem cell bank at UMass to close at year's end
Public release date: 28-Jun-2012 [ | E-mail | Share ]
Contact: Stephanie Desmon sdesmon1@jhmi.edu 410-955-8665 Johns Hopkins Medical Institutions
Johns Hopkins researchers, working with an international consortium, say they have generated stem cells from skin cells from a person with a severe, early-onset form of Huntington's disease (HD), and turned them into neurons that degenerate just like those affected by the fatal inherited disorder.
By creating "HD in a dish," the researchers say they have taken a major step forward in efforts to better understand what disables and kills the cells in people with HD, and to test the effects of potential drug therapies on cells that are otherwise locked deep in the brain.
Although the autosomal dominant gene mutation responsible for HD was identified in 1993, there is no cure. No treatments are available even to slow its progression.
The research, published in the journal Cell Stem Cell, is the work of a Huntington's Disease iPSC Consortium, including scientists from the Johns Hopkins University School of Medicine in Baltimore, Cedars-Sinai Medical Center in Los Angeles and the University of California, Irvine, as well as six other groups. The consortium studied several other HD cell lines and control cell lines in order to make sure results were consistent and reproducible in different labs.
The general midlife onset and progressive brain damage of HD are especially cruel, slowly causing jerky, twitch-like movements, lack of muscle control, psychiatric disorders and dementia, and eventually death. In some cases (as in the patient who donated the material for the cells made at Johns Hopkins), the disease can strike earlier, even in childhood.
"Having these cells will allow us to screen for therapeutics in a way we haven't been able to before in Huntington's disease," says Christopher A. Ross, M.D., Ph.D., a professor of psychiatry and behavioral sciences, neurology, pharmacology and neuroscience at the Johns Hopkins University School of Medicine and one of the study's lead researchers. "For the first time, we will be able to study how drugs work on human HD neurons and hopefully take those findings directly to the clinic."
Ross and his team, as well as other collaborators at Johns Hopkins and Emory University, are already testing small molecules for the ability to block HD iPSC degeneration. These small molecules have the potential to be developed into novel drugs for HD.
The ability to generate from stem cells the same neurons found in Huntington's disease may also have implications for similar research in other neurodegenerative diseases such as Alzheimer's and Parkinson's.
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Turning skin cells into brain cells
Public release date: 28-Jun-2012 [ | E-mail | Share ]
Contact: Diane Schrick diane.schrick@gladstone.ucsf.edu 415-734-2538 Gladstone Institutes
SAN FRANCISCO, CAJune 28, 2012Scientists at the Gladstone Institutes and an international team of researchers have generated a human model of Huntington's diseasedirectly from the skin cells of patients with the disease.
For years, scientists have studied Huntington's disease primarily in post-mortem brain tissue or laboratory animals modified to mimic the disease. Today, in Cell Stem Cell, the international team shows how they developed a human model of Huntington's disease, which causes a diverse range of neurological impairments. The new model should help scientists better understand the development of Huntington'sand provide better ways to identify and screen potential therapeutics for this devastating disease.
This new model comes at a time of concentrated federal efforts to accelerate solutions for diseasesincluding a number of debilitating conditions that touch only small percentages of the population. Last year, the National Institutes of Health consolidated its efforts to attack rare diseases under the new National Center for Translational Sciences.
Huntington's is such a rare disease, although it is the most common inherited neurodegenerative disorder. It afflicts approximately 30,000 people in the United Stateswith another 75,000 people carrying the gene that will eventually lead to it. Caused by a mutation in the gene for a protein called huntingtin, the disease damages brain cells so that people with Huntington's progressively lose their ability to walk, talk, think and reason.
"An advantage of this human model is that we now have the ability to identify changes in brain cells over timeduring the degeneration process and at specific stages of brain-cell development," said Gladstone Senior Investigator Steve Finkbeiner, MD, PhD. "We hope this model will help us more readily uncover relevant factors that contribute to Huntington's disease and especially to find successful therapeutic approaches."
In this research, Dr. Finkbeiner and others took advantage of advanced "reprogramming" techniques pioneered by Gladstone Senior Investigator Shinya Yamanaka, MD, PhD. They reprogrammed skin cells from Huntington's disease patients into stem cells known as induced pluripotent stem cells, or iPS cellswhich can become virtually any cell type in the body. The researchers then instructed the iPS cells to develop into neurons, a key type of brain cell. Importantly, each cell line contained a complete set of the genes from each Huntington's disease patient. Because each patient has a different pattern of disease onset and duration, this model may replicate Huntington's more faithfully than animal models do. The model is likely to prove more useful in understanding the disease's progression.
"The iPS cells will provide insights into Huntington's disease, helping us to develop new therapies and test drug candidates," said Dr. Finkbeiner, who is also a professor of neurology and physiology at the University of California, San Francisco, with which Gladstone is affiliated. "We hope that drugs developed with this new human model will have greater success in clinical trials. The track record of animal models for predicting therapies that will work in people has been poor, making drug discovery for neurodegenerative diseases very costlyand therefore less attractive to drug companies. We hope to change that."
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Gladstone scientists use stem cell technology to tackle Huntington's disease
The stem cell bank that was a marquee piece of Governor Deval Patricks effort to bolster the life sciences industry will run out of funding at the end of the year and close, state and University of Massachusetts Medical School officials said Wednesday. The state invested $8.6 million in public funds to establish the bank at the medical schools Shrewsbury campus.
That decision in 2008 was seen then as a bold statement of support for research on human embryonic stem cells during a time when federal funding for work on the controversial cells was restricted. But advances in technology and changes to federal policies rapidly made the bank obsolete, state officials said.
The laboratory grew and stored human stem cells, which are capable of becoming any cell in the body, and made them available to scientists nationwide for use in experiments to study diseases such as diabetes and spinal cord injuries. When it is dismantled, several thousand vials of stem cellswill be sent back to the research centers where they originated, and the equipment will be given to other UMass labs.
Susan Windham-Bannister, president of the Massachusetts Life Sciences Center, a quasi-public agency that oversees the $1 billion life sciences initiative, defended the decision to initially fund the stem cell bank. She said there are many examples of technology that in hindsight are unnecessary, but at the time it was conceived, when the investment was made, it was absolutely state of the art. The center, she said, was one of them.
Originally, the bank was seen as a repository for embryonic stem cell lines that were being created but were not eligible for federal funding under Bush-era restrictions. The field has evolved significantly since then, with President Obamas loosening of restrictions on federal funding and the development of new technologies for making stem cells.
Still, stem cell banks are seen as useful by some. The California Institute for Regenerative Medicine, for example, is preparing to invest $10 million in its own stem cell banking initiative, and another $20 million to underwrite the creation of stem cells from patients with specific diseases.
Massachusetts Senate minority leader Bruce Tarr, Republican of Gloucester, said he was concerned that lawmakers had not been told the bank would close.
Given the fact that this is a resource that was created by an act of the Legislature, I would hope anyone seeking to change its status would consult with the Legislature, he said. The notion has always been we have been working hard to make Massachusetts a leader in stem cell research, and I dont know how ceasing the operations of the stem cell bank advances that goal.
Researchers who had developed and sent some of the 18 embryonic stem cell batches, called lines, that are currently available at UMass expressed their disappointment.
I think the closing of the UMass bank, where we had anticipated maintaining a lot of our lines, means we will have to come up with an alternative, said Dr. George Q. Daley, a stem cell scientist at Boston Childrens Hospital and the Harvard Stem Cell Institute who has sent about half a dozen stem cell lines to the bank. He said he received a call Tuesday from Joseph Laning, who joined UMass Medical School in 2010 to run the bank, alerting him that the bank would be closed.
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UMass stem cell lab to close
SILVER SPRING, Md., June 28, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a biotechnology provider of cell and gene therapy solutions, announced today that the final Asset Purchase Agreement, as amended, has been executed and the transfer of the assets of SG Austria Pte. Ltd. to Nuvilex has begun.
Austrianova Singapore Private Limited (ASPL) and Bio Blue Bird AG (BBB) are now functioning as wholly-owned subsidiaries of Nuvilex, Inc. subject to the terms of the Asset Purchase Agreement between the companies. By acquiring the shares of ASPL and BBB, NVLX has acquired the former SG Austria assets which include, but are not limited to all licenses, IP, patents, personnel, capabilities, and facilities associated with the cell encapsulation technology for cancer treatment and all other applications. Completing this acquisition allows Nuvilex to move forward toward conducting the pancreatic cancer treatment trial and advancing its use for diabetes therapy and stem cells.
The Executive Chairman for SG Austria and ASPL, Professor Dr. Walter Gunzburg commented, "We are pleased to inform our combined shareholders and investors that activities we aimed to complete prior to this point have been accomplished. As a result, our management teams decided the timing was right to complete the transfer of assets."
SG Austria and ASPL's Chief Executive, Dr. Brian Salmons stated, "Together, we see this as an important step that increases our ability to move ahead with our collective operational goals. We anticipate announcing additional information about plans for the live cell encapsulation technology in the near future."
Dr. Robert F. Ryan, Nuvilex's Chief Executive added, "The management teams of both Nuvilex and ASPL have been working closely together and are very pleased to be able to make this transfer of assets happen. We will continue our effort to develop treatments for cancer and other diseases, and we hope to play a substantial role in the future of biotechnology and cell and gene therapy."
About Nuvilex
Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Our company's clinical offerings will include cancer, diabetes and other treatments using the company's cell and gene therapy expertise and live-cell encapsulation technology.
The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13494
Safe Harbor Statement
This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.
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Nuvilex Finalizes Asset Purchase Agreement and Completes Acquisition of SG Austria Assets