Pluristem Therapeutics stock soared 113% Monday on Nasdaq, after the Haifa-based biotherapeutics firm, which specializes in stem-cell therapy products, announced it had successfully completed a preclinical study on its treatment of stroke patients. The study conducted under the supervision of Prof. Frank Emmrich, head of the Fraunhofer Institute in Leipzig, Germany, demonstrated statistically significant improvement in functional and neurological condition in rats, after injection of the treatment.
This is Pluristem's second preclinical study of the therapy, which involves injection of placental stem cells. The first study, which was conducted in France, showed improvement in mice that received the cells even 10 hours after occurrence of the stroke, compared to existing therapies on the market, which require the patient to receive treatment no later than three hours after the occurrence.
But at Pluristem there is even more excitement over the upcoming human clinical trial for its therapy for lower extremities arteriosclerosis this summer. "This will be the first clinical study in the world, in which placental stem cells are injected into humans, so everyone is on tenterhooks, as we are. But once we are able to prove it [viable], the sky is the limit," Pluristem CEO Zami Aberman said at the firm's offices in Haifa.
Advertisement
Aberman is a great believer in the potential inherent in placental stem cells. Up until a few years ago, the prevailing attitude was that the placenta was useless after birth. But Pluristem began examining the placenta as an interesting source of stem cells for biological therapies, based on the assumption that the source of stem cells for production of blood cells is the placenta rather than the umbilical cord.
Arteriosclerosis is a disease in which clots are formed in blood vessels, mainly in the legs. Diabetics, heavy smokers and overweight people for the bulk of those suffering from arteriosclerosis. According to Aberman's data, the number of patients worldwide reflects a $4 billion market for the therapy, and this is just for the lower limbs. In the U.S. alone there are about 12 million patients, and Pluristem believes that the blood circulation in their legs can be improved, and amputations prevented.
The first stage of clinical tests will begin between July and October, and continue over 6-12 months. The test, which will include 20 patients, involves a single injection, followed by monitoring of the healing process.
Aberman is expecting initial results by mid 2009. The next two stages will be far broader, and include 200 patients each. The paperwork for the first stage has already been submitted in Germany and the U.S., and Pluristem expects U.S. Federal Drug Administration approval of the Haifa plant by mid-June.
Haaretz.com, the online edition of Haaretz Newspaper in Israel, offers real-time breaking news, opinions and analysis from Israel and the Middle East. Haaretz.com provides extensive and in-depth coverage of Israel, the Jewish World and the Middle East, including defense, diplomacy, the Arab-Israeli conflict, the peace process, Israeli politics, Jerusalem affairs, international relations, Iran, Iraq, Syria, Lebanon, the Palestinian Authority, the West Bank and the Gaza Strip, the Israeli business world and Jewish life in Israel and the Diaspora.
