Back to top

Analyst Blog

Pluristem Therapeutics, Inc. (PSTI - Snapshot Report) recently announced that it has taken possession of its new state-of-the-art facility after initiating the validation process earlier in Jan 2013. 

Pluristem is currently shifting its manufacturing process to this facility. According to Pluristem, this is the world’s first commercial cell therapy manufacturing facility.
 
Pluristem, headquartered in Israel, develops placenta based cell therapies. The cells from placenta are derived using the company’s proprietary PluriX therapy and are known as PLacental eXpanded (PLX) cells.
 
The new facility will enable Pluristem to produce large quantities of PLX cells using its patented 3D bioreactor technology. In addition, the new manufacturing facility will allow Pluristem to produce different PLX candidates with the potential capacity of over 150,000 doses on an annual basis. 
 
We note that Pluristem develops and manufactures cell therapy products in collaboration with companies like United Therapeutics (UTHR - Analyst Report) or through research and clinical institutions. 
 
Management believes that PLX cells can be effective in supporting bone marrow transplantation and in treating bone marrow suppression from radiation and chemotherapy. 
 
We remind investors that the medical regulatory body for biological medicinal products in Germany, the Paul-Ehrlich-Institute (PEI), has approved the company’s request to conduct a phase II study using PLX-PAD cells in patients suffering from intermittent claudication (IC).
 
IC is a subset of peripheral artery disease (PAD).  The phase II study for IC will be a placebo-controlled trial wherein the safety and efficacy of two doses of PLX-PAD cells will be compared to placebo among 150 patients. 
 
According to the SAGE Group and HCUP 2007 inpatient data, approximately 14 million people in the US suffer from IC, representing a cost of approximately $2.5 billion on an annual basis to the healthcare system.
 
Pluristem plans to open three clinical sites in Germany where the protocol will be same as in the US where patient enrollment and dosing is in progress.  Moreover, the company plans to open clinical sites in Israel, once regulatory approval is received. 
 
Meanwhile, Celgene Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corporation (CELG - Analyst Report) is also doing research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases.
 
Pluristem carries a Zacks Rank #3 (Hold). Pharma stocks, such as Medivation Inc (MDVN - Analyst Report), currently appear to be attractive with a Zacks Rank #1 (Strong Buy). 

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
SUPER MICRO… SMCI 27.00 +10.25%
CANADIAN SO… CSIQ 38.34 +8.18%
BANCO DO BR… BDORY 16.78 +8.05%
CENTURY ALU… CENX 26.97 +7.97%
WILLDAN GRO… WLDN 11.38 +5.86%