UPDATE 1-Pluristem stem cell drug approved for advanced trial

Tue Jan 18, 2011 7:59am EST

* Stem cell therapy treats peripheral artery disease

* Targets 2014 for marketing of treatment

* Stock halted in Tel Aviv pending announcement

(Adds details, CEO quotes, stock halt)

By Tova Cohen

TEL AVIV, Jan 18 (Reuters) - Israeli stem cell therapy company Pluristem Therapeutics (PSTI.O) has won U.S. and European approval to conduct an advanced trial for its treatment of peripheral artery disease, a degenerative disorder.

The Israeli biotech company has completed early Phase I trials and said on Tuesday it will be able to conduct an advanced Phase II/III trial in both Europe and the United States to treat the end stage of peripheral artery disease (PAD), known as critical limb ischemia.

PAD is an obstruction of blood vessels, usually in the leg, causing pain, difficulty in walking and leading eventually to amputation.

Chief Executive Zami Aberman said Pluristem will also conduct a Phase II trial to test its treatment on an earlier stage of the disease, placing it on track for a preventative treatment in addition to treating amputation-destined cases.

The treatment for both stages of the disease targets a 20 million patient market.

"We believe that 2014 will be the time for approval and marketing in Europe and the United States for critical limb ischemia," Aberman told Reuters.

"It's a very unique situation that we can discuss with both the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agencies) the same clinical study protocol."

The Phase II trial will involve up to 150 patients in Germany and the United States while the Phase II/III trial will be conducted throughout Europe and the United States and enroll up to 500 patients.

"It's great news for us," Aberman said, adding the company will need to raise money to fund the trials.

Pluristem's shares were halted for trading in Tel Aviv pending the announcement.

In December the company filed for a shelf offering of up to $75 million.

Unlike many other companies that use embryonic stem cells, Pluristem harvests cells from the placenta after a woman gives birth, so there is no ethical issue on using embryos.

Pluristem said in September early clinical trials in the United States and Europe show its placenta-derived cell therapy is safe and improves quality of life in patients with PAD. [ID:nLDE6860HS]

Aberman has said Pluristem is in talks with large pharmaceutical companies in the United States, Europe and Japan to market the treatment though he would not disclose names.

"We have a lot of interest," he said. (Editing by Mike Nesbit)

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