Date: 2017-01-12
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Pluristem Therapeutics (Israel)
Product: PLX-PAD cells
Action
mechanism: cell therapy. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. The PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20 million patients in the Peripheral Artery Disease (PAD) market.
Disease: intermittent claudication
Therapeutic area: Cardiovascular diseases
Country: USA, Germany, Israel, South Korea
Trial
details: IC is characterized by leg cramps and pain while walking, caused by insufficient blood flow through arteries that are partially obstructed by atherosclerotic plaques. Pluristem's IC Phase II trial will evaluate the safety and efficacy of two doses (150x106 and 300x106) of PLX-PAD cells versus placebo administered via two intramuscular injections (day one and week twelve post initial injection). The study population will be comprised of 150 patients with IC, Fontaine class IIb; Rutherford category 2-3, in 11 U.S. clinical sites. This trial also includes sites in Germany and in Israel. The primary efficacy end point of the trial will be 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.
Latest
news: * On January 12, 2017, Pluristem Therapeutics announced that it has completed enrollment of all 172 patients in a multinational Phase II trial of its PLX-PAD cells in the treatment of intermittent claudication , a peripheral artery disease. Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea, and Israel. * On July 8, 2014, Pluristem Therapeutics, a developer of placenta-based cell therapies, announced the initiation of South Korean sites in the Phase II study assessing PLacental eXpanded (PLX) cells in the treatment of intermittent claudication (IC). Patient screening is now underway at three clinical centers, making South Korea the fourth country to participate in this randomized, double-blind, placebo-controlled Phase II trial. The trial has been ongoing at clinical sites in the U.S., Israel and Germany with an enrollment target of 150 patients. The South Korean part of the study is being conducted by CHA Bio & Diostech (Kosdaq: CHA) under an exclusive licensing agreement for the use of PLX cells for peripheral artery disease (PAD) in South Korea. Under the terms of Pluristem’s licensing agreement with CHA, if there is regulatory approval for a PLX product in South Korea Pluristem and CHA will establish a joint venture (JV) co-owned by the parties; they will share the revenues and income generated through sales of PLX cell therapies in the South Korean market. In May, Pluristem received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) to use PLX cells in South Korean trials. * On November 13, 2013, Pluristem Therapeutics has announced that the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA), has approved Pluristem’s Investigational New Drug (IND) Application to conduct a Phase II study using PLX-PAD cells for the treatment of intermittent claudication. The IND approved by the MFDS mirrors INDs already approved by regulators in the USA, Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech Co, Pluristem’s South Korean partner, will fund the trial and conduct it in its healthcare facilities. * On October 2, 2013, Pluristem Therapeutics has announced that the Israeli Ministry of Health has approved the company’s request to initiate a Phase II study using its PLacental eXpanded (PLX) cells in the treatment of intermittent claudication, a subset of peripheral artery disease (PAD). This approval is part of the company’s previously announced strategy to conduct a multi-national study for this indication. The protocol will be the same one used for the study previously approved in the U.S. * On September 16, 2013, Pluristem Therapeutics has announced that the FDA has lifted the clinical hold previously placed on its U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013. In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily addressed all the clinical hold issues and the Company may proceed with the study. Pluristem’s Phase II Intermittent Claudication (IC) study uses the Company’s PLX-PAD cells. The study protocol will be modified by tightening patient’s eligibility criteria and by adding oral anti-histamines and a safety follow-up period for 24 hours post study treatment. * On June 4, 2013, Pluristem Therapeutics has announced that it has received notification from the FDA that its United States phase II Intermittent Claudication (IC) study (IND 15038) has been placed on clinical hold due to a serious allergic reaction in a case which required hospitalization. Out of 74 patients enrolled in Pluristem’s trials to date, this is the first case of a serious allergic event. This event occurred in a patient with multiple diseases which may have influenced the severity of the event. The patient was discharged from the hospital the following day, following the resolution of all her symptoms. The FDA will issue a letter within the next 30 days detailing a list of questions and requests for information from Pluristem. * On August 23, 2012, Pluristem Therapeutics has 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 its PLacental Expanded (PLX) cells in the treatment of intermittent claudication. 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 its 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. * On August 13 2012, Pluristem Therapeutics has announced it has selected Cato Research as its contract research organization for the German portion of the Company’s Phase II trial in intermittent claudication under the auspices of the Paul-Ehrlich Institute (PEI). Cato will serve as Pluristem’s applicant for its Clinical Trial Application to the PEI and to the ethics committees of the three study sites where the trials will be conducted. The trial will evaluate the safety and efficacy of Pluristem’s PLacental eXpanded (PLX-PAD) cells in treating IC, a subset of peripheral artery disease (PAD). * On April 17, 2012, Pluristem Therapeutics has announced that the FDA has granted the company clearance to start a Phase II clinical trial using the company’s PLX-PAD cell product candidate for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).
Pluristem's IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo. Both were administered via intramuscular injections in 172 patients with IC, Fontaine class IIb, Rutherford category 2-3. The primary efficacy endpoint is the change in maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints include hemodynamic and quality of life measurements. Safety parameters are also being assessed.
