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]
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:
- There are already dozens if not hundreds of approved THERAPIES in the world going back over half a decade....
- What is Prochymal, then? Prochymal is an allogenic (from a donor) , ex vivo (outside the organism) cultured batch of mesenchymal (bone marrow) stem cells implanted into the patient who has received a bone marrow transplant in the interest of suppressing his immune response so the new/foreign bone marrow can take seed.
- So...Prochymal may become the first stem cells derived from (allogenic) outside sources and cultured (ex vivo) in a dish to be approved for use in a human patients with GVHD...IN THE USA.
- In related news; in September of 2009, Stemedica (a different company) was granted a license to manufacture stem cells for therapies - Stemedica Licensed to Manufacture Clinical Grade Stem Cells
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.