Key Developments For Pluristem Therapeutics, Inc.
Pluristem Therapeutics, Inc. (PSTI.O) (Consolidated Issue listed on NASDAQ Capital Market)
Pluristem Therapeutics Inc. Completes Dosing of First Group of Patients in Europe
Pluristem Therapeutics Inc. announced that it has completed dosing of the first of three dosage groups of patients in Europe with its placenta-derived cell therapy product, PLX-PAD, in a Phase I dose-escalating clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The three patients treated in this group received the lowest of the three doses in the trial. The Data Safety Monitoring Board (DSMB), an independent board monitoring the safety of PLX-PAD, will meet in approximately 30 days to determine dose escalation to the next dose level to be administered in this trial.
Pluristem Therapeutics Inc. Presents Three Month Follow-Up Data From First Patient To Receive Placental Derived PLX-PAD
Pluristem Therapeutics Inc. announced that it will present three month follow-up data from the first patient to receive PLX-PAD at both the 1st Annual Conference of the German-Israeli Life Science Committee at the Life Science Center in Düsseldorf, Germany and at the DigestScience Congress in Lille, France. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the company`s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). PLX-IBD cells were administered in vivo to mice in which inflammatory bowel disease was induced using the intra-rectal administration of trinitrobenzene sulphonic acid (TNBS). There was a statistically significant improvement in a standard inflammatory histological score in those animals given PLX-IBD intravenously compared to vehicle controls or those animals receiving daily treatment with five-aminosalicylic acid.
Pluristem Therapeutics Inc. Announces Three Month Follow Up Data From First Patient To Receive PLX-PAD
Pluristem Therapeutics Inc. announced that safety and potential efficacy parameters were demonstrated by the three month follow up data from the first patient ever to receive its placenta derived cell therapy product, PLX-PAD. The patient is participating in a Phase I dose-escalating clinical trial in Europe with PLX-PAD, the Company's product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The first patient was treated with the lowest of three doses and has completed the three month follow up with the following results: The patient's Rutherford Category (a scale of the severity of a patient's limb ischemia) decreased by 50%; The patient has reported that the ability to walk pain free increased from 20 meters (approximately 60 feet) to 120 meters (approximately 360 feet), representing a 500% improvement over baseline. In addition, the patient's VascuQol score (quality of life score), VAS score (pain score), and the hemodynamic parameters, ankle-brachial index, toe-brachial index, and transcutaneous oxygen pressure, improved compared to baseline.
Pluristem Therapeutics Inc. To Raise $3.0 Million In Registered Direct Offering
Pluristem Therapeutics Inc. announced that it has entered into definitive agreements with selected institutional investors to sell common stock and warrants for aggregate gross proceeds of approximately $3.0 million, before deducting placement agent fees and estimated offering expenses. The offering includes 2,702,822 shares of common stock and warrants to purchase 1,081,129 shares of common stock. The price per share of Common Stock is $1.12, and the exercise price of the warrants is $1.60. The Warrants will be exercisable for a period of five years commencing six months following the issuance thereof. The closing is scheduled to take place no later than October 12, 2009. The offering is expected to close on or about October 12, 2009. Roth Capital Partners, LLC acted as the exclusive placement agent for the offering.
Pluristem Therapeutics Inc. Begins Enrollment In U.S. With Unmatched Placenta-Derived Stem Cell Product PLX-PAD In Phase I Clinical Trial For Treatment Of Peripheral Artery Disease
Pluristem Therapeutics Inc. announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company's product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of two clinical sites in the U.S. Duke University Medical Center will also be screening patients for the trial. The initiation of this study follows the approval of the Company's Investigational New Drug (IND) application to begin clinical trials with PLX-PAD by the U.S. Food & Drug Administration (FDA). The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 12 adults with the disease will be included in this dose escalating trial.
