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Eyes on the Road; Hands on the Wheel: OSIR, EFII, HEV : Small Cap Stock Analysis : Small Cap Stocks and Penny Stocks For Big Ret

Posted Jul 05 2010 12:00am

What’s it all about?

Osiris is utilizing smart marketing technique and business strategy by first dipping their foot into the shallow end of the stem cell therapy pool.

They want to treat Heart, Diabetes, GI and joints with their stem cell product “Prochymal” so they are wisely starting by treating graft versue host disease (GVHD) in bone marrow transplant (BMT) recipients.

[Standard treatment for GVHD is corticosteroids (used to suppress the T-cell mediated immune onslaught on the host tissues).] 

This really won’t ruffle too many pharma feathers and BMT’s and GVHD have a ~40 year history.  Then they piggy back diabetes, heart, crohn’s, etc on top of the approval for the GVHD treatment .  Wise move.  I hope it works! - dg]

http://static.seekingalpha.com/uploads/2008/11/5/saupload_f88c0a0b_39ea_428c_91bf_a961def48c29.jpg

EYES ON THE ROAD; HANDS ON THE WHEEL:  OSIR

Osiris Therapeutics ( OSIR ) Climbs on Regulatory Milestone

By Dennis Askew – Published: July 26, 2010 9:06:08 AM PDT

OSIR: Health Canada Grants Priority Review for Stem Cell Therapy

First up this morning we have Osiris Therapeutics Inc., (OSIR) http://www.osiristx.com/ currently trading in the $7.79 range on a 3-Month average daily trading volume of 108,303 shares. OSIR has a 52-week high of $15.20 set on 08-27-09 with current trailing twelve month revenues of $43+ million and a positive, corresponding diluted EPS of +$0.07. I like those earnings.

Last week the Biologics and Genetic Therapies Directorate of Health Canada completed its initial evaluation and accepted for full review OSIR’s New Drug Submission of Prochymal, an adult stem cell therapy for the treatment of graft vs. host disease.

[Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. It can also take place in a blood transfusion under certain circumstances. - wiki

Side note: GVHD is virtually eliminated when using autologous (from the patient's own body) stem cells for treatments. -dg]

Based on a separate review of summary clinical data, Health Canada notified OSIR that the application has been granted Priority Review, shortening the examination period from 300 to 180 days. If successful, Prochymal would become the world’s first approved stem cell therapy.

["the world’s first approved stem cell therapy" Not quite right:

- dg]

Prochymal, which is in Phase III clinical trials for the treatment of acute and steroid refractory graft versus host disease and Crohn’s disease, as well as for the repair of gastrointestinal injury resulting from radiation exposure. OSIR is also developing its Prochymal drug candidate for the repair of heart tissue following a heart attack, and for the protection of pancreatic islet cells in patients with type 1 diabetes.

OSIR is also developing Chondrogen, a biologic drug candidate for the treatment of osteoarthritis and the reduction of pain in the knee. At nearly 50% off its high, returning ttm earnings, and making product-to-market strides, OSIR is a long-term (1 Yr) ‘Buy’ consideration for me.

via Eyes on the Road; Hands on the Wheel: OSIR, EFII, HEV : Small Cap Stock Analysis : Small Cap Stocks and Penny Stocks For Big Returns – SmallCap Network .

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