* Pluristem to start trading in Tel Aviv on Dec. 19
* Company may need to raise money to fund advanced trials
* Would seek to raise only equity, not debt
By Tova Cohen
TEL AVIV, Dec 15 (Reuters) - Nasdaq-listed stem cell therapy company Pluristem (PSTI.O) is to also list its shares on the Tel Aviv Stock Exchange from Sunday, with a view to being able to raise further money if needed to fund advanced clinical trials.
The Israeli biotech company 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 the degenerative disorder peripheral artery disease (PAD). [ID:nLDE6860HS]
PAD is an obstruction of blood vessels, usually in the leg, causing pain, difficulty in walking and leading eventually to amputation.
Pluristem plans advanced clinical trials in the first half of 2011 and is holding talks with the U.S. Food and Drug Administration and the European Medicines Agency regarding the next step.
“The question is which study we will do and under which agency,” Chief Executive Zami Aberman told Reuters on Wednesday.
“It can be a Phase II or a Phase II-III study approved by the FDA, EMA, or both. Based on the outcome of discussions with authorities we will decide our plan.”
The company can finance a Phase II study requiring 80 patients on its own but if it receives approval for a more advanced Phase III trial with 500 patients, it will need to raise money.
“This is linked to our listing in Tel Aviv,” Aberman said.
“We will raise any money needed through equity, not debt,” he added, noting that the company had made a decision not to take on any debt. To date Pluristem has raised $42 million.
Phase I trials, conducted at three university hospitals in the United States and one in Berlin, showed the cells are effective in treating the end stage of PAD, called critical limb ischemia.
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.
Israeli institutional investors face restrictions investing in companies traded only on Nasdaq and prefer to invest in shares listed in Tel Aviv, Aberman said.
“The biomed sector has raised a lot of interest with 50 healthcare companies on the Tel Aviv Stock Exchange,” he said. The dual listing will enable 13.5 hours of trade in the stock, which will have the ticker symbol PLTR PLTR.TA.
The increased visibility will also help the company recruit high-quality workers as it seeks to expand. Pluristem, which has 50 employees in Israel, plans to add another 10 in 2011.
Pluristem has invested in upgrading its production facility and research and development labs in Haifa to prepare for future clinical trials, Aberman said.
“We at Pluristem envision the company not as pure R&D but also as a company manufacturing a product. We decided to upgrade our facilities to produce all the products for Phase I and now we are preparing the facility for Phase II and Phase III to meet the criteria of the FDA and EMA,” he said.
Pluristem is in talks with large pharmaceutical companies in the United States, Europe and Japan to market the treatment though Aberman would not disclose names. Such a deal would enable Pluristem to test its treatment for additional indications such as earlier stages of PAD and neuropathic pain. (Editing by Greg Mahlich)