Key Developments: Pluristem Therapeutics Inc (PSTI.W)
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22 May 2013
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Latest Key Developments (Source: Significant Developments)
Pluristem Therapeutics Inc Receives Regulatory Approval To Commence Phase I Study Of Pluristem's PLX-PAD Cells For Pulmonary Arterial Hypertension
Pluristem Therapeutics Inc announced that following favorable preclinical studies, United Therapeutics Corporation received approval to perform a human Phase I study in Australia using Pluristem's PLacental eXpanded (PLX-PAD) cells in patients diagnosed with Pulmonary Arterial Hypertension (PAH). United Therapeutics and Pluristem entered into a licensing agreement pursuant to which United Therapeutics will develop, market and sell Pluristem's PLX-PAD cells for PAH. United Therapeutics plans to conduct a single center, open-label, dose-escalation study in patients diagnosed with PAH. The study will enroll up to nine patients in three dosing levels with PLX-PAD cells administered intravenously (IV). The primary endpoint of study is to evaluate the safety of PLX-PAD cells in a follow-up period of one year. Secondary efficacy endpoints at six weeks post-treatment are designed to assess cardio-respiratory function and include six-minute walk distance, cardiac hemodynamic parameters via a right heart catheterization and echocardiogram and pulmonary metabolism via a positron emission tomography (PET) scan. Under terms of Pluristem's licensing agreement with United Therapeutics Corporation, United Therapeutics made an upfront payment of $7 million to Pluristem. Pluristem is also eligible to receive regulatory and other payments totaling up to an additional $48 million with United Therapeutics bearing all the costs of conducting all of the clinical trials for the indication of PAH. Full Article
Pluristem Therapeutics Inc Reports On Progress Of Phase I/II Clinical Trial For Treatment Of Muscle Injury
Pluristem Therapeutics Inc announced the progress of ongoing double blind Phase I/II clinical trial to test the safety and efficacy of PLacental Expanded (PLX) cells in the treatment of muscle injury. This is the first time PLX cells have been used in patients following surgically induced muscle trauma. The study is being conducted at the Orthopedic Clinic on the campus of the Charité University Medical School in Berlin, Germany. The muscle injury being studied is the gluteal buttock muscle that has been surgically traumatized during hip replacement surgery. The primary endpoint of the study is safety with a secondary endpoint of gluteal muscle function at six months with the ability to perform biopsies of the involved muscle. PLX cells will be injected directly into the surgical incision after it has been sutured. Three groups of six patients will be enrolled in the study. From each group of six patients, two patients will receive a high dose of PLX cells, two patients will receive a low dose of PLX cells and two patients will receive placebo. The group of six patients has been dosed without a adverse event related to either the placebo or the PLX cell product candidate. Full Article
Pluristem Therapeutics Inc Receives FDA Orphan Drug Status Designation For Treatment Of Aplastic Anemia
Pluristem Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has designated Pluristem's PLacental eXpanded (PLX) cells orphan drug status for the treatment of aplastic anemia. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits include a seven-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants. This is Pluristem's second orphan drug designation from the FDA. The Company also received orphan drug status from the FDA for PLX cells for the treatment of Buerger's disease in August of 2011. Full Article
Pluristem Therapeutics Inc Receives Approval To Expand Phase II Clinical Trial In Intermittent Claudication To Germany From Paul-Ehrlich-Institute
Pluristem Therapeutics Inc announced that the Paul-Ehrlich-Institute (PEI), the medical regulatory body for biological medicinal products for the Federal Republic of Germany, has approved the Company's request to initiate a Phase II study using PLX-PAD cells in patients suffering from Intermittent Claudication (IC). IC is a subset of Peripheral Artery Disease (PAD). Pluristem's IC Phase II is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is comprised of approximately 150 patients with IC: Fontaine class IIb, Rutherford category 2-3. The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed. Full Article
Rosen Law Firm Announces Investigation of Securities Claims Against Pluristem Therapeutics Inc
Rosen Law Firm announced that it is investigating potential securities claims against Pluristem Therapeutics Inc resulting from allegations that the Company may have issued materially inaccurate statements to the investing public. On May 9, 2012, Pluristem issued an announcement touting that its PLX Cells saved the life of a seven-year old girl. This announcement caused the Company's stock to rise more than 13%. On September 19, 2012 the Company closed a public offering of 8 million shares of common stock - raising over $32 million. In connection with the offering, the Company issued a Prospectus that was filed with the SEC on September 14, 2012. The Prospectus mentioned the medical results for the seven-year old girl as an important clinical result supporting the effectiveness of PLX cells, omitting that she later died. On November 8, 2012, Bloomberg published an article stating that on or before September 12, 2012 the seven-year old girl had died. This announcement caused the Company's stock to fall, over 22%. The Rosen Law Firm is investigating a securities class action lawsuit on behalf of Pluristem investors. Full Article
Pluristem Therapeutics Inc Announces Closing of Public Offering of Common Stock and Warrants to Purchase Common Stock
Pluristem Therapeutics Inc announced the closing of its previously announced firm commitment underwritten public offering of 8,000,000 units, at a purchase price of $4.00 per unit, with each unit consisting of one share of the Company's common stock and one warrant to purchase 0.35 of a share of the Company's common stock, at an exercise price of $5.00 per share. The net proceeds to the Company are approximately $30 million, assuming no exercise of the warrants and after deducting underwriting commissions and discounts and estimated offering expenses payable by the Company. Jefferies & Company, Inc. acted as sole book-running manager for the offering. Oppenheimer & Co. Inc. acted as co-lead manager for the offering. Needham & Company, LLC and Maxim Group LLC acted as co-managers for the offering. In addition, Leader Capital Markets Ltd. and Rothschild Inc. acted as financial advisors to the Company in connection with the offering. Full Article
Pluristem Therapeutics Inc Announces Pricing of Public Offering of Common Stock and Warrants to Purchase Common Stock
Pluristem Therapeutics Inc announced that it has priced a firm commitment underwritten public offering of 8,000,000 units, with each unit consisting of one share of the Company's common stock and one warrant to purchase 0.35 of a share of the Company's common stock, at a purchase price of $4.00 per unit for an aggregate gross offering amount of $32 million. The offering is expected to close on or about September 19, 2012. Each warrant will be exercisable for a period of five years following the issuance thereof at an exercise price of $5.00. The Company has also granted the underwriters a 30-day option to purchase up to 1,200,000 shares of common stock and/or warrants to purchase up to 420,000 shares of common stock to cover over-allotments, if any. Jefferies & Company, Inc. is acting as sole book-running manager for the offering. Oppenheimer & Co. Inc. is acting as co-lead manager for the offering. Needham & Company, LLC and Maxim Group LLC are acting as co-managers for the offering. In addition, Leader Capital Markets Ltd. is acting as a financial advisor to the Company in connection with the offering. Full Article
Pluristem Therapeutics Inc Announces Proposed Public Offering Of Common Stock And Warrants To Purchase Common Stock
Pluristem Therapeutics Inc announced that it intends, subject to market and other conditions, to offer shares of its common stock and warrants to purchase shares of its common stock in a registered public offering. The shares of common stock and warrants to purchase shares of common stock are being offered as units. Pluristem also intends to grant the underwriters of the offering an option to purchase additional shares of common stock and warrants to cover over-allotments, if any. Pluristem plans to use the proceeds from the offering to conduct clinical trials, research and product development activities and for general corporate purposes, including general working capital purposes. Jefferies & Company, Inc. is acting as sole book-running manager for the proposed offering. Oppenheimer & Co. Inc. is acting as co-lead manager for the proposed offering. Needham & Company, LLC and Maxim Group LLC are acting as co-managers for the proposed offering. In addition, Capital Markets Ltd. is acting as the Company's financial advisor in connection with the proposed offering. Full Article
Pluristem Therapeutics Inc Commences U.S. FDA Phase II Clinical Trial For Intermittent Claudication
Pluristem Therapeutics Inc announced that it will initiate Phase II clinical trials in the United States in the first week of September 2012 to evaluate the safety and efficacy of PLacental Expanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). Pluristem has already received Institutional Review Board (IRB) approval for the trial protocol for five out of the eleven U.S. clinical site locations via relationship with Western IRB, which has approved Pluristem's protocol. Site initiation will begin on September 5th at Duke University Medical Center with other sites becoming active in the weeks following. Pluristem also plans to initiate sites in Europe and Israel in parallel to the eleven U.S. sites. Pluristem's IC Phase II trial will evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is comprised of approximately 150 patients with IC: Fontaine class IIb, Rutherford category 2-3. The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed. Full Article
Pluristem Therapeutics Inc Charite Berlin-Brandenburg Center for Regenerative Therapies Renew Five-Year Collaborative Research Agreement
Pluristem Therapeutics Inc announced it has renewed a five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charite - University Medicine Berlin. The original five-year Collaborative Research Agreement was signed between the parties in 2007. Full Article
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