Pluristem Takes A Huge Step For The Entire Cell Therapy Sector

One of our favorite emerging names on the Nasdaq, Pluristem Therapeutics (PSTI), creator of regenerative medicine based on stem cells that come from the human placenta, is moving fast.

They just had a major news announcement that, the United States Food and Drug Administration, has granted the company clearance, to start a Phase II clinical trial, using the company's PLX-PAD cell product candidate, for the treatment of Intermittent Claudication, a subset of peripheral artery disease.

Intermittent Claudication, is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during exercise. The prevalence of Intermittent Claudication in the United States alone, is approximately 14 million patients and represents a cost of approximately $2.5 billion annually to the National Healthcare Bill.

The trial will include 132 patients and which will benefit from Pluristem's off-the-shelf' PLX properties, achieved in its three dimensional, proprietary technology platform. This proprietary 3D expansion process allows for the efficient, controlled, mass production of cell therapy product.

That Pluristem has now received the world's first FDA clearance for an Intermittent Claudication clinical trial which is a huge step for the entire cell therapy sector. That makes them a stock to continue following.

A fundamental and important point to this study is the fact that Pluristem will be giving patients a repeat dose of their PLX-PAD cells as the company believes the treatment of peripheral artery disease will require recurrent dosing of the patient.

The company has proven in animals that PLX-PAD cells can be given repeatedly, even from the same placental source. It was important to Pluristem to prove to the regulators that PLX-PAD can be given twice from the same source without evoking an immune response. This recurrent dosing schedule is unique to Pluristem, as no other cell therapy company has given their cells repeatedly from the same source. Pluristem believes that their ability to repeatedly injected patients is because of the placental source of cells and growing them in a 3D manner.

Recently the company announced plans to scale up its manufacturing facility to accommodate upcoming clinical trials where safety and potential efficacy have already been shown in humans with peripheral artery disease. Plans for the next phase of clinical trials, done overseas, are moving forward rapidly.

Just as we advised last month, accumulation of the stock at these levels may prove to be a very smart move. Technically and fundamentally, we may be looking at much more upside given the returning volume and interest in the stock.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.