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Biotech4cast is a biotechnology investor community. At Biotech4cast.com members rate biotechnology clinical programs across several attributes (Effectiveness, Safety, etc.). Members rate upcoming events on measures of importance to the clinical program and the company. An FDA calendar is... More
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  • Pluristem's Program for Critical Limb Ischemia Receives a High Rating
    Critical limb ischemia (NYSE:CLI) is a life threatening disorder along the spectrum of peripheral artery disease(PAD). Pain, numbness, decreased circulation, open sores and gangrene are symptoms of CLI. The outcome for a substantial portion of CLI patients includes loss of limb and/or death.

    Pluristem Therapeutics is advancing their placenta-derived cell therapy, PLX-PAD, towards a Phase II/III study in the U.S. and Europe. This article provides a review of Pluristem's PLX-PAD therapy for CLI clinical program. Five criteria (Safety, Effectiveness, Side Effects, Chemistry Manufacturing and Controls (NYSE:CMC), and Financial Strength) on a five point scale are used to rate this clinical program. Phase I interim trial results for 21 patients are found in a September 2010 press release.

    Rating Pluristem Therapeutics Critical Limb Ischemia ProgramSafety:
    Phase I trial data for 21 patients shows the PLX-PAD treatment to be safe with regards to adverse events and the immunological response to treatment. Stem cell therapies have the potential to elicit a life threatening immunological reaction. There was no such reaction up to three months since treatment. Adverse events were attributed to CLI and not the PLX-PAD treatment.

    Effectiveness:
    The three month interim data shows promising results for subjective measures of quality of life (81% of patients) and pain reduction (71% of patients). Effectiveness is also demonstrated on objective measures of blood flow (62% of patients) and  tissue oxygenation (62% of patients). It is unclear at this time why some patients did not benefit from the therapy.

    Side Effects:
    The treatment is well tolerated and the side effect profile is very good. The allogenic, off-the-shelf treatment only requires the patient to receive intramuscular injections which compares favorably to the bone marrow harvest required in competing stem cell therapies.

    Chemistry, Manufacturing & Controls:
    The Pluristem manufacturing process involves taking adult stem cells from the placenta (mother's side of the placenta) after birth. Pluristem uses a proprietary three-dimensional bioreactor to expand and grow the stem cells which emerge as PLX cells or PLacental eXpanded cells. The cells are grown in a company owned Good Manufacturing Practices (cGMP) facility. The PLX cells are used off-the-shelf without tissue matching or immunosuppression. It is important to note that this manufacturing process side-steps the controversial process of using human embryonic stem cells. The PLX cells are administered via intramuscular injection. While the reports thus far are encouraging, manufacturing defects may become apparent when larger trials are conducted.

    Financial Strength:
    In a 10-Q filing dated February 9, 2011, Pluristem states that their products will likely not be for sale for at least three years. However, revenue may come from grants or partnerships with large pharmaceutical companies. Pluristem did receive $5M from an October, 2010 private placement and $38M in a February, 2011 public offering. The company believes it has sufficient funds to operate until at least the end of 2013. By then additional trial data will be available, and if positive will probably allow for additional funds to be raised. However, the scope and nature of the trials may exceed Pluristem's estimates and this may require additional fund raising. Pluristem is exploring the possibility of using the PLX cells in stroke, diabetes, and other diseases. Clinical trials for these diseases will require additional capital.

    Overall:
    Pluristem's PLX-PAD clinical program scores high on safety, tolerability and CMC. However, stem cell therapies in general are unproven and there have been issues with the underlying technology. Long term follow-up, greater number of participants and additional study sites will test Pluristem's CMC capabilities and may reveal any safety issues.

    Average ratings are given for Effectiveness and  Financial Strength. About one-third of patients did not show improvement on objective measures of effectiveness. It will be interesting to see if the treatment is effective for additional patients overtime and whether the benefits of treatment will continue for those patients already experiencing improvement. Pluristem is a microcap biotechnology company, in relatively good financial shape but this could change for better or worse depending on developments in the CLI clinical program.

    Pluristem's potential treatment for CLI shows promise where a treatment option other than vascular surgery or amputation is greatly needed. This review has provided a baseline assessment of this program as it advances to later stage trials.



    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
    Feb 16 5:02 PM | Link | Comment!
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