Date: 2012-07-18
Type of information: Clinical research agreement
Compound: services related to enrolling and sustaining clinical site for a Phase II study using PLX-PAD cells for the treatment of intermittent claudication
Company: Pluristem Therapeutics (Israel) CPC Clinical Research (USA)
Therapeutic area: Cardiovascular diseases
Type agreement: clinical research
Action mechanism:
Disease: intermittent claudication
Details: Pluristem Therapeutics has announced that in anticipation of initiating a Phase II study using PLX-PAD cells for the treatment of intermittent claudication, the company has entered into a collaborative agreement with CPC Clinical Research (CPC) for services related to enrolling and sustaining clinical sites. This partnership will leverage CPC’s clinical study expertise, including patient recruitment, study monitoring, pharmacovigilance, site audits, quality assurance, biostatistics, data management and medical writing.
As previously reported, Pluristem received FDA clearance for a Phase II study using PLX-PAD cells for the treatment of intermittent claudication. Data from two phase I studies in Critical Limb Ischemia (CLI), the end stage of PAD, indicates that PLX-PAD is safe and potentially effective.
The intermittent claudication study population will be comprised of 150 patients with Fontaine class IIb; Rutherford category 2-3 in a dose escalation, placebo controlled, double blinded study.
Financial terms:
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