DAVID GRANOVSKY

Archive for July 26th, 2010|Daily archive page

Osiris – FLASHBACK to Sept, 2009

In BUSINESS OF STEM CELLS on July 26, 2010 at 6:07 pm

I think this paragraph from Sept 2009 is as true today as it was almost a year ago -dg

Certainly major pharma companies are tracking the news flow from Osiris closely. Keenly aware that they got into the biologics game too late, but nonetheless wary of the incredibly complicated biology involved, Big Pharma is in a state of cognitive dissonance when it comes to stem cells. “They’d like to see a true product,” Giebel says, noting that the preference is for allogeneic therapies, “because one size fits all.” The problem with creating an allogeneic therapy, which arguably could be treated as a product in the traditional pharma sense, is that the stem cells are derived from someone other than the ultimate recipient, bringing into play the challenge of immune response. (Mesenchymal stem cells are unique in that they are not “seen” by the immune system and in fact have the effect of down-regulating T-cells, making them potentially effective in autoimmune indications, like GvHD.)


Osiris Hiccup In COPD Barely Registers In Stem Cell Sector

…Lazard analyst Joel Sendek, for example, advised investors to wash their hands of the company, based on the COPD slip and earlier troubles with a clinical trial in Crohn’s disease that resulted in a high placebo response. But for the most part, investors and analysts shrugged off the data, choosing to view it as a learning experience in a secondary indication, while keeping their eyes focused on the pending GvHD results.

It would have been nice to see Prochymal succeed in COPD because that’s a very large market, “but is it a major setback? I don’t think so,” says Lutz Giebel, PhD, a managing partner at SV Life Sciences. Giebel co-founded the embryonic stem cell company CyThera Inc. in 1999; the biotech merged with another SC company, BresaGen Inc., in 2004 to form Novocell Inc.

Certainly major pharma companies are tracking the news flow from Osiris closely. Keenly aware that they got into the biologics game too late, but nonetheless wary of the incredibly complicated biology involved, Big Pharma is in a state of cognitive dissonance when it comes to stem cells. “They’d like to see a true product,” Giebel says, noting that the preference is for allogeneic therapies, “because one size fits all.” The problem with creating an allogeneic therapy, which arguably could be treated as a product in the traditional pharma sense, is that the stem cells are derived from someone other than the ultimate recipient, bringing into play the challenge of immune response. (Mesenchymal stem cells are unique in that they are not “seen” by the immune system and in fact have the effect of down-regulating T-cells, making them potentially effective in autoimmune indications, like GvHD.)

Meanwhile, autologous therapies, in which the patient’s own cells are collected, treated, and put back in, are more transplant than therapy, and not an appealing acquisition for pharma in Giebel’s opinion. But given the nascent state of the field and as yet no clear clinical success stories, there are many others with divergent views.

via BioPharma Today: Osiris Hiccup In COPD Barely Registers In Maturing Stem Cell Sector.

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.

Oman: Stem cell bank ‘to open soon’

In STEM CELLS IN THE NEWS on July 26, 2010 at 4:00 am

The World Health Organization’s “health system ranking” puts the Arab country of Oman at 8th in the world, way ahead of the USA at 37th.  It’s a shame…

but I guess it makes sense that they are moving forward on autologous/adult stem cell research and stem cell banking faster than the US is. -dg

Oman: Stem cell bank ‘to open soon’

26 July 2010

MUSCAT: Stem cell therapy has the potential to radically change the treatment of human disease. Stem cells are the natural repair kit of the human body.

Considering the absorption of such a revolutionary method by advanced countries the Sultanate of Oman is almost on the verge of operating the Stem Cell Bank and establishing a stem cell transplantation unit. According to Dr Muhanna Al Muslahi, senior consultant haematologist and head of directorate of pathology and laboratory medicine, the Royal Hospital, ‘The stem cell bank has been established – tested and connected. Reagents and certain consumables required for harvesting and storing stem cells have been ordered and are on the way. Once they are received stem cell bank will start functioning any time now.’

He said, ‘To begin with, sick patients will be given priority and later when we expand we will store stem cells from all those who want to store them for future treatment. For transplantation unit to be established, special treatment rooms have been made available within the extension of National Oncology Centre. In Oman, the inherited blood disorder disease is not uncommon and so the facility will be a boon to the people of Oman. But the transplantation unit is the second step as first we need the stem cell bank to function which can happen any time now.’

Two staff have been trained at the King Hussein Medical Centre, Jordan – one in stem cell collection and the other in processing and storage. Two other staff have been trained at the Royal Free Hospital in London for six weeks recently. They include Mohammed Ali Al Rawahi, Zahra Al Mahrazi, Fakhra Al Farsi and Suhila.

The department has two doctors under training in Canada and Saudi Arabia and expect them back after two years.

Says Dr Muhanna, ‘Autologous stem cell collection (The autologous stem cell transplant involves relocation of cells from the patient’s own blood) and transplantation unit will also be initiated by the year-end or beginning of 2011 once the expansion of the National Oncology Centre has been completed.’

// He adds, ‘Cold blood storage is also feasible, but it will not be offered at the moment.

It can be considered in the future once the current transplant centres in the country are expanded and the need for cord blood transplants are established justifying the cost of storage and ethical issues behind it.

“In the long term allogenic bone marrow will also be needed to be considered after assessing the projected workload, costs and budgeting requirements and availability of other related services.”By Aftab H Kola

© Times of Oman 2010

via Oman: Stem cell bank ‘to open soon’.

Medical marijuana has been shown to facilitate stem cell implantation

In Medical Marijuana, STEM CELLS IN THE NEWS on July 26, 2010 at 1:00 am

As far back as April, 2009, research showed that medical marijuana can help with stem cell implantations.  Stem cells and weed, a potent combination! – dg

The uses for this medicine range from pain relief to stopping the spread of breast cancer. It has also been shown to facilitate stem cell implantation. Marijuana can be used to treat Alzheimer’s, arthritis, cancer, glaucoma, Parkinson’s and other conditions.

Florida could be the next medical marijuana state
Organizers around Florida ready to collect signatures

The Florida Division of Elections has approved a petition that may place a constitutional amendment on the Florida ballot that would allow the use of marijuana for medical purposes.

People United For Medical Marijuana has received approval to circulate a petition to place this issue before Florida voters in 2010. This amendment would give patients the right to grow, purchase, posses and obtain marijuana for medical treatment.

According to medical reports there are more than 1.7 million seriously ill people in the state of Florida that could benefit from marijuana’s medicinal properties. The uses for this medicine range from pain relief to stopping the spread of breast cancer. It has also been shown to facilitate stem cell implantation. Marijuana can be used to treat Alzheimer’s, arthritis, cancer, glaucoma, Parkinson’s and other conditions.

“Patients need a safe, affordable, and effective medication. We hope Florida will lead the nation in marijuana research to further its uses as a medicine.” said Kim Russell, chairman of People United For Medical Marijuana..

http://fortmyers.floridaweekly.com/news/2009/0408/top_news/020.html

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