DAVID GRANOVSKY

Posts Tagged ‘HOST’

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

In BUSINESS OF STEM CELLS on July 26, 2010 at 5:58 pm

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:

  1. There are already dozens if not hundreds of approved THERAPIES in the world going back over half a decade....
  2. 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.
  3. 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.
  4. 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

- 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.

STEM CELLS & GVHD

In ALL ARTICLES, STEM CELLS IN THE NEWS, VICTORIES & SUCCESS STORIES on February 13, 2009 at 9:55 pm
GVH/GVHD

GVH/GVHD

Stem Cells Cure Boy With Graft Versus Host Disease (GVHD) At Duke

Posted 13 February, 2009 in Bone Marrow Donations/Transplants, Cerebral Palsy, Graft Vs Host Disease, Leukemia

In what has been an amazing week for Adult Stem Cell research, Kameron Kooshesh has been cured of his Graft Versus Host Disease (GVHD) after receiving Osiris’ Adult Stem Cell product Prochymal in a clinical trial at Duke University.

Kameron, a young 14 year old boy had been suffering from Graft Versus Host Disease (GVHD) after receiving a bone marrow transplant to cure his Leukemia at the age of 9. GVHD is a disease in which the foreign cells introduced by the bone marrow transplant (taken from a human donor) attack the host’s (the patient) organs and tissues because they do not recognize them.

Kameron had a severe gastrointestinal problem due to the GVHD. It was very bad and it limited him so much he couldn’t even go up stairs.

He enrolled at a clinical trial run by Dr. Joanne Kurtzberg at Duke University. Dr. Kurtzberg is famous in this blog for the work she has done helping children with cerebral palsy with stem cells taken from their own cord blood.

At Duke, Kameron was given Prochymal, which is a stem cell product from Osiris made up of stem cells taken from the bone marrow of healthy human donors.

Here are the results:

“At one point, he couldn’t climb stairs,” His mother Janet recalled.

Now, Kameron has no problem climbing the stairs. He’s also back in school full time. His recovery started quickly after taking part in a clinical trial at Duke.

“Within three weeks – it was just incredible,” said Kooshesh. “Absolutely incredible.”

“We’ve seen more than half the children we’ve treated respond with full resolution of the graft vs. host disease which is remarkable,” said Dr. Joanne Kurtzberg, Director of the Pediatric Blood & Marrow Transplant Program at Duke Children’s.

A “full resolution” sounds great to me and I’m sure it sounds even better to the young man, Kameron.

Click here to see the full story and a slow loading stem cell video

Click here to see more on Osiris’ Prochymal to help GVHD

UPDATE: Osiris just came out with a press release announcing results of their trial using Prochymal to treat Heart Attack patients.

via Adult Stem Cell Research.

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