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By Patrick Crutcher

One of the companies whose stock has risen over 150% since we started covering it in early October, Pluristem Therapeutics Inc. (NASDAQ:PSTI), today announced that both the European Medical Agencies (EMA) and the Food and Drug Administration (FDA) have come to agreement about Company’s planned clinical development program for PLX-PAD.

Based on the feedback from both the EMA and FDA, Pluristem feels that it is now in a position to advance towards two clinical studies with its PLX-PAD cells: a joint FDA-EMA Phase II/III study of PLX-PAD for CLI and a Phase II study for IC under the FDA and the Paul Ehrlich Institute, the German competent authority in the European Union.

“PLX-PAD has shown promise throughout its initial clinical development, and I am pleased that both the EMA and FDA have acknowledged our proposed comprehensive clinical development plan, which may lead to an advanced cell therapy product that could help millions of PAD patients.

"The completion of two Phase-I CLI clinical studies, performed in parallel in Germany and the U.S., placed Pluristem in a unique position to discuss with the regulatory agencies an approach that should allow a single clinical study protocol to be accepted by both agencies“, commented Zami Aberman, chairman and chief executive officer of Pluristem.

“What is particularly exciting about this development,” continued Aberman, “is that it places us – for the first time – on-track for a potentially preventative treatment for PAD in addition to treating amputation-destined cases."

“PLX-PAD has shown an early read-out of efficacy throughout its clinical development and I am pleased that PLX-PAD has made the necessary progress from a regulatory perspective, to move forward with advanced trials,” commented Edwin Horwitz, MD, PhD, president of the International Society for Cell Therapy, and the head of Pluristem’s scientific advisory board. “I am excited that the PLX-PAD clinical trials will be conducted in the EU and the U.S. under the same clinical protocol, bringing the therapy closer to market and to those CLI patients in need of improved therapies.”

PSTI's cell therapy obtains its cells from the placenta, or after-birth, which comes after the baby’s birth. Accordingly, Pluristem Therapeutics provides the solution to the embryonic stem cell controversy since Pluristem’s cells are not embryonic – in fact, Pluristem does not harm or even touch the donor to obtain its cells. Pluristem Therapeutics gets its cells from what has been designated as medical waste until now.

Pluristem grows its cells in a fashion that is protected by patents. The cells can be given “off-the-shelf” without any matching needed between Pluristem Therapeutics’ cells and the patient receiving the cells. Once injected, Pluristem’s cells, called PLX (Placental eXpanded) cells, respond to signals sent from injured tissue to secrete a mixture of anti-inflammatory and new-blood-vessel forming proteins that treats the injury.

Full Phase 1 data from their trial investigating PLX cells is expected sometime this quarter. In September, they announced results from the 3-month follow up of 21 patients, where PLX-PAD was found to be safe and well-tolerated. This initial data was quite promising: 13/21 patients (62%) had improvements in blood flow and tissue oxygenation, and 17/21 patients (81%) had measured improvements in quality of life (as measured by the King's College Score for Quality of Life assessment). Additionally, 15/21 patients (71%) experienced a reduction in pain from baseline. If their initial results still hold, it would be extremely promising for the future in this indication. Today's regulatory news speaks to the potential their treatment offers CLI patients.

While investors have been excited about Pluristem Therapeutics' progress, we would urge our readers to be aware of a $75 million existing shelf registration, that was made effective on January 11th. In October 2010, Pluristem announced that it had raised approximately $5.25 million through a private placement. That offering included 4,375,000 shares of common stock at a per share purchase price of $1.20 and four year warrants to purchase 2,625,000 shares of common stock at an exercise price of $1.80 per share, exercisable six months following the issuance. Another capital raise sometime in 2011 is certainly something that should be considered going forward; for now, they have enough cash until the end of 2011.

Keep in mind that management at Pluristem is currently seeking licensing agreements for a partnership in several indications, like Crohn’s, MS, Ischemic stroke and others. Following the Mesoblast deal with Cephalon, Pluristem should be able to secure a similar, but smaller deal. Once they have a solid balance sheet, Pluristem can really push their pipeline deeper into trials and initiate studies in different indications like neuropathic pain and stroke. Their pipeline seems ripe for exploration, only question is, which big pharma wants to go along for the ride?

More info:

Pluristem’s $75 million shelf.

Positive 3-month data from Phase 1 study in CLI / neuropathic pain discovery.

PLX cells may help treat ischemic stroke.

Top-line interim results from the Phase 1 study in CLI.

$5 milion capital raise in October.

Disclosure: No position

Source: Agencies Agree to Consider Clinical Studies Proposal for Pluristem Pipeline