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Pluristem: Second Patient With ‘Life-Saving’ Cells Died

by David WainerBusiness Week
November 9th, 2012

Pluristem Therapeutics Inc. (PSTI) said a second of the three patients given the company’s experimental stem cells has died after Pluristem touted the treatments as “life-saving.”

Pluristem shares soared after the Haifa, Israel-based company issued news releases in May, August and September announcing the treatments. Pluristem raised $34 million in a share sale in September without announcing that the first of those patients, a 7-year-old girl with a bone-marrow disease, had died. The company issued a press release today acknowledging the death of a second patient, though it wouldn’t say when the death occurred.

Pluristem sank the most in 21 months in Nasdaq Stock Market trading yesterday after Bloomberg News reported Pluristem hadn’t disclosed the girl’s death before the share sale. The company said today it wasn’t aware of her death at the time of the offering.

“The pediatric patient referred to in the Bloomberg article survived for six months, another patient survived for four months, and the third is still alive,” the company said in today’s statement. “Pluristem believes that these results exceeded longevity expectations. The unfortunate deaths of the patients do not diminish these results.”

‘Medical Miracle’

The May 9 announcement of the girl’s treatment was headlined, “Compassionate Use of Pluristem’s PLX Cells Saves the Life of a Child After Bone Marrow Transplantation Failure.” On Aug. 6, the company said the cells had been administered to a 54-year-old woman with cancer suffering from bone-marrow failure. Pluristem quoted her doctor in the news release describing her subsequent recovery “as a medical miracle.” On Sept. 9, the company said a 45-year-old man with leukemia had received a “life-saving” treatment with the cells.

A spokeswoman for Pluristem declined to say today whether it was the 54-year-old woman or the 45-year-old man who had died, or provide any details about the death.

Pluristem’s announcements helped lift the stock from its 2012 low of $2.02 in March to an intraday high of $5 on Aug. 17.

“Such press releases risk misleading investors by creating overly optimistic account of scientific research,” Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics, said in a blog posting yesterday. “More importantly, press releases describing miracles and life-saving cures are harmful because they give seriously ill individuals an unrealistic account of effectiveness of experimental stem cell interventions.”

Stock Sale

The stock plunged after the company announced on Sept. 12 that it planned to sell shares to raise money for research expenses. Pluristem completed the sale Sept. 19. The girl died Sept. 12, a company spokeswoman said last month.

Pluristem didn’t announce the girl’s death because it stopped following her progress after she left the hospital, Chief Executive Officer Zami Aberman said in an interview last month. She had been critically ill, and her death was unrelated to the stem-cell treatment, the company said in today’s statement. Pluristem learned of her death “at the discretion of her family and physician” in her home country of Romania after the stock sale, the company said.

Pluristem acquired the rights to the technology underlying its PLX stem cells in 2003. The cells aren’t approved for sale anywhere in the world. The company has completed two early-stage clinical trials in a total of 27 patients. Israel, like many countries including the U.S., allows so-called compassionate use of unapproved medicines in patients for whom no other treatment options exist.

Pluristem rose 14 percent to close at $3.24 in New York trading, giving the company a market value of $186 million. The stock dropped 23 percent yesterday, the most since Jan. 27, 2011.

“Pluristem wishes to emphasize that compassionate-use cases are entirely experimental and last-resort efforts in desperate situations and obviously not predictive of ultimate success or failure,” the company said today. 

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