Osiris Therapeutics Receives Title of European Orphan Drug Designation for Prochymal®

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), the leading stem cell company developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that the European Medicines Agency (EMA) has designated Osiris as the Orphan Drug title holder for Prochymal (remestemcel-L).

The EU Commission adopted the decision to transfer the designation of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council. The Decision will appear in the EU Community Register of Orphan Medicinal Products.

In Europe, Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, to companies that develop drugs for underserved patient populations.

In the EU, the Orphan Drug designation for Prochymal is for the treatment of acute graft versus host disease (GvHD). Prochymal, a first-in-class allogeneic stem cell therapy, has already received approval in Canada and New Zealand for the treatment of acute GvHD in children, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). Recently, Swissmedic, the Swiss agency responsible for the evaluation of drugs, notified Osiris that Prochymal will be evaluated under its Rapid Authorization Procedure upon submission of the marketing application.

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 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 in a Phase 2 trial for acute myocardial infarction.

About Osiris Therapeutics

Osiris Therapeutics, Inc., having developed the worlds first approved stem cell drug, Prochymal, is the leading stem cell company. 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 50 U.S. and 156 foreign patents.

Osiris, Prochymal, Chondrogen, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIR-G)

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Osiris Therapeutics Receives Title of European Orphan Drug Designation for Prochymal®

Osiris Rises on European Stem-Cell Drug Title Decision

Osiris Therapeutics Inc. rose the most in eight months after European regulators transferred the orphan drug title for a stem cell therapy to the company, making it easier to seek a buyer or partner for the treatment.

Osiris gained 9 percent to $7.65 at the close in New York, its biggest intraday jump since June. The European Medicines Agency made the title transfer for the intravenous treatment Prochymal, which treats a disease that attacks bone marrow- transplant recipients, Columbia, Maryland-based Osiris said in a statement today.

The orphan designation provides 10 years of market exclusivity if the medicine is approved, and the simplifying of who holds the title clears the way for a transaction should Osiris opt to sell Prochymal to another company, said Edward Tenthoff, a senior analyst with Piper Jaffray & Co. in New York.

Theyve started to get approvals for Prochymal, said Tenthoff, who has a neutral rating on the stock. Theres a way for them to monetize that.

Tenthoff said Osiriss former partner, Sanofis Genzyme unit, probably held Prochymals orphan drug title before. Osiris didnt name the previous title holder in its statement.

Osiris had declined 22 percent this year through Feb. 15. An orphan drug typically targets rare diseases and is intended for a small number of patients with few treatment options.

Prochymal is the worlds first approved drug with a stem cell as its active ingredient, Osiris said.

Osiris said in a separate statement it won a patent challenge in Australia. Prochymal is approved in New Zealand and Canada to treat children with acute graft versus host disease, a bone marrow transplant complication that kills as many as 80 percent of children affected. Its the first drug approved to treat the disease, the company said.

The drug is available in seven other countries, including the U.S., under an expanded access program, Osiris said. Such programs make investigational drugs available to treat patients with serious conditions or diseases who cannot participate in a controlled clinical trial.

The company hasnt sought a U.S. Biologics License Application approval yet, which may be what has weighed on the stock this year, Tenthoff said.

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Osiris Rises on European Stem-Cell Drug Title Decision

Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc

TORONTO, ONTARIO--(Marketwire - Feb 19, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT" or the "Corporation") a life sciences company developing stem cell-related technologies, today announced a joint-venture agreement with ReNeu Inc. of Calgary, AB, Canada, ("ReNeu") and NexGen Medical Systems, Inc. of Melbourne, FL, USA ("NexGen").

ReNeu is a company formed to commercialize drug-based therapies to treat central nervous system disorders in combination with devices and processes for direct-to-brain administration. Subject to the definitive agreement, SCT and NexGen will license their respective technologies to ReNeu under world-wide,royalty-free licenses for the use of NexGen''s FDA-cleared EViTAR line of proprietary intracranial delivery systems and SCT''s NTx-265, -428 and -488 covering the proprietary use of drugs for the regeneration of endogenous neural stem cells.

To the knowledge of the Corporation the EViTAR intracranial delivery system is the only FDA-cleared Class II medical device currently indicated for the injection of material into the brain during intracranial procedures. It is designed for site-specific, low-volume, high-concentration delivery of drugs to target tissues in the brain of patients suffering from stroke, neurodegenerative disease, and tumors. SCT''s NTx-265 is a therapeutic regimen of approved and clinically well-defined drugs that include human Chorionic Gonadotropin ("hCG") and erythropoietin ("EPO") for the regeneration of neural stem cells in patients following stroke, traumatic brain injury and other neurological conditions.

"ReNeu''s perceptive innovation that the combination of SCT''s award-winning, proprietary discoveries by Dr. Sam Weiss, Director of the Hotchkiss Brain Institute, if administered in a direct-to-brain process, holds the promise of delivering the regenerative results that Dr. Weiss'' discovery originally proposed.NexGen''s EViTAR family would appear to be an ideal vehicle for the clinical expansion of the SCT products and we are enthusiastic about its prospects," said David Allan, Executive Chairman of SCT.

Under the Letter of Agreement SCT will own 50% of the joint-venture for which the definitive agreement is anticipated within 60 days, subject to final due-diligence and usual conditions being met.

"The breakthrough benefit to patients that could be expected to result from a positive clinical demonstration from the combination of these two critical elements for the treatment of neurologically degenerative diseases could be of significant importance for the treatment of patients with stroke and other neurological conditions," said Dr. Joseph Tucker, founding CEO of ReNeu. "The most effective preclinical treatments from Dr. Weiss'' work licensed to SCT were the direct-to-brain approaches, which clearly indicated the prospect of important benefit to patients when developed clinically. At the time, SCT proceeded in its clinical development with systemic rather than site-specific administration because of the absence of availability of a direct-to-brain approach, with the consequence that only limited amounts of SCT''s drug combination reached the brain and equivocal clinical outcomes were achieved. We have high expectations that this fortuitous combination of these two novel approaches could have an importantly different and positive outcome."

"NexGen is very excited about this collaboration with SCT and ReNeu," said John Kucharczyk, CEO of NexGen Medical Systems. "The novel treatment methods have the potential to introduce entirely new therapies for several neurological diseases and disorders. NexGen''s proprietary EViTAR neurocatheters are designed for delivery of therapeutic agents directly to target tissues in the brain and spinal cord, which is expected to significantly reduce side-effects associated with systemic delivery of drugs," Kucharczyk added.

ReNeu''s initial board will be composed of David Allan, Executive Chairman of Stem Cell Therapeutics, Dr. John Kucharczyk, CEO of NexGen Medical Systems, Dr. Brad Thompson, Chairman & CEO of Oncolytics Biotech and Dr. Joseph Tucker, founding CEO of ReNeu. The Company intends to vigorously pursue regulatory approval to move the combined technologies into clinical trials with a target of clinical initiation in 2014.

SCT will retain all rights to its endogenous stem cell-stimulating technology other than direct-to-brain administration.

About Stem Cell Therapeutics Corp.:

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Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc

Arthritic dogs helped by stem-cell treatment

A Halifax veterinarian is using stem cells to treat dogs suffering from arthritis.

Eamon Draper, a vet at the Fairview Animal Hospital, said they take stem cells from the dog's fat and inject that into its joints.

The procedure takes a few hours and Draper says the improvements can last for years.

"What we're looking for is an animal that's more comfortable and moving around more easily," he said.

The $1,900 process encourages extra blood flow and repairs damage.

David Peyton's 12-year-old black lab Athena was hobbled by arthritis, but the procedure helped her.

"She was sore moving. Getting up and out of her bed and taking her out for her walk, she would come back limping and sore," he said.

A week after the treatment, he said she is moving easier. He's planning a long walk with her at Point Pleasant Park this weekend.

"We wanted to make sure that the last few years of her life were comfortable and pain free and that she can still have a nice quality of life for her senior years," Peyton said.

Draper has treated eight dogs so far. It's a new use of the technology.

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Arthritic dogs helped by stem-cell treatment

Skin cells 'key to beating blindness'

Melbourne, Feb. 18 (ANI): A team of scientists from Australia are turning human skin cells into eye cells by using stem cell research to find a way to treat a common but incurable form of blindness.

According to figures, age-related macular degeneration that results from dying retinal cells, affects one in seven older Australians and costs the 5.15 billion dollars a year.

The team at Melbourne's Centre for Eye Research Australia (CERA) takes skin cells from affected patients, turns them into stem cells and then into new retinal cells, Herald Sun reported.

These cells are then compared with the patient's damaged cells, allowing them to see in detail what's gone wrong.

A new charity, the National Stem Cell Foundation of Australia, has devoted its first investment to the project, bringing Kathryn Davidson, a US stem cell expert, to the centre from Seattle.

Davidson said that stem cell research has lets her team "mimic the disease in a dish," with a view to finding means for better diagnosis and treatment. (ANI)

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Skin cells 'key to beating blindness'

Learn more about stem cell therapy at Vail Athletic Club Friday

VAIL The Vail Athletic Club, part of the Vail Vitality Center wellness experience at Vail Mountain Lodge, introduces a lecture which offers an in-depth look at new developments in cellular therapy for the treatment of joint pain. Stem Cell Therapy is a groundbreaking procedure that uses a patient's own stem cells to repair or replace damaged joint tissue. Dr. Scott Brandt of ThriveMD in Edwards is one of few physicians in the country trained in this procedure. Brandt will present details about this innovative new therapy at the Vail Athletic Club on Friday at 6 p.m.

Stem cell therapy is a minimally invasive procedure that begins with harvesting a patient's stem cells from his or her own fat reserves most often from the abdominal region. The tissue is isolated in a state-of-the-art cell-processing laboratory. The cells are then injected into the damaged joint using a minimally invasive technique with the assistance of fluoroscopic guidance. Once injected, the cells can sense proteins generated from cartilage damage and, in response, those cells have the ability to make chondrocytes cells found in healthy cartilage. This new procedure relieves the pain and limitations of arthritic joint disease without resorting to an invasive joint replacement surgery.

Brandt will discuss the process of isolating autologous adipose derived stem cells, the details of the procedure, and answer questions about this treatment for cartilage, ligament and tendon injuries.

For more information or to register call 970-476-7960. The lecture is offered as a fundraiser for the Eagle County Education Foundation and a $15 donation is suggested. Advance reservations are required and space is limited.

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Learn more about stem cell therapy at Vail Athletic Club Friday

Vic stem cell bid to beat blindness

Scientists are turning human skin cells into eye cells by using stem cell research, with their sights set on unravelling a common but incurable form of blindness.

Age-related macular degeneration, which results from dying retinal cells, affects one in seven older Australians and costs the country's economy $5.15 billion a year, figures show.

But little is understood about how or why it occurs.

Enter a team at Melbourne's Centre for Eye Research Australia (CERA), which is taking skin cells from affected patients, turning them into stem cells and then into new retinal cells.

These are then compared with the patient's damaged cells, allowing the researchers to see in detail what's gone wrong.

A new charity, the National Stem Cell Foundation of Australia, has devoted its first investment to the project, bringing Kathryn Davidson, a US stem cell expert, to the centre from Seattle.

'We know (with macular degeneration) that certain cells in the retina die, and so do the other cells that depend on them, but we need to know how and why,' Dr Davidson told those gathered at the charity's launch in Melbourne on Monday.

Dr Davidson said stem cell research lets her team 'mimic the disease in a dish', with a view to finding means for better diagnosis and treatment.

Melbourne therapist and mum Michelle Kornberg, who was diagnosed with age-related macular degeneration aged 30, knows the fear and frustration at the lack of available relief.

Doorways and blinds appear as uneven waves, and written words would intermittently vanish from sight, she said.

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Vic stem cell bid to beat blindness

Stem cell-based bioartificial tissues and organs

Feb. 18, 2013 Surgeon Paolo Macchiarini has made his name by successfully transplanting bioengineered stem cell-based trachea, composed of both artificial and biological material. He now plans to use the technique to recreate more complex tissues, such as the esophagus and diaphragm or organs such as the heart and lungs. He has also made an experimental attempt to regenerate brain in mice and rats.

This is part of the news he will be presenting during his seminar at the scientific AAAS Annual Meeting in Boston.

In June 2011, media all over the world reported about a ground breaking transplant, where a patient received an artificial trachea covered in his own stem cells. The result was an artificial windpipe with biological functions. To date, five operations have been carried out using this technique.

"We learn something from each operation. This means we can develop and refine the technique. We are also evaluating how we can transfer our experiences to other fields, such as neurology. The aim is to make as much use of the body's own healing potential as we can," says Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institutet, and responsible for the surgery.

At the AAAS Annual Meeting, he will talk about how he believes the technology can be used in the future. This will include:

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Stem cell-based bioartificial tissues and organs

Osiris Therapeutics Successfully Defends Key Stem Cell Patent Challenge

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), the leading company focused on developing and marketing stem cell products to treat serious medical conditions, announced today the successful conclusion of a patent challenge in Australia by an opponent whose identity under Australian law was not disclosed. The patent at issue covers the administration of mesenchymal stem cells (MSCs), including Prochymal (remestemcel-L), for the treatment of inflammatory conditions involving the gastrointestinal tract, including Crohns disease and ulcerative colitis.

As acknowledged in the Australian Official Journal of Patents Supplement, all claims to the patent will be maintained in full. The claims specifically include the use of allogeneic MSCs, an attribute central to making an off-the-shelf MSC product possible.

In 2012, Prochymal, an intravenous formulation of MSCs, became the world's first stem cell drug to gain approval by an internationally recognized regulatory authority. Prochymal is also the first drug approved for acute graft versus host disease (GvHD) - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis. 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.

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 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 in a Phase 2 trial for acute myocardial infarction.

About Osiris Therapeutics

Osiris Therapeutics, Inc., having developed the worlds first approved stem cell drug, Prochymal, is the leading stem cell company. 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 50 U.S. and 156 foreign patents.

Osiris, Prochymal, Chondrogen, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIR-G)

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Osiris Therapeutics Successfully Defends Key Stem Cell Patent Challenge