Pluristem Therapeutics Inc. announced that it has reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the last trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI).
“With this achievement we have advanced our strategy to expedite commercialization of our cell products. Pluristem is now positioned favorably to accelerate negotiations with those Japanese pharma companies interested in becoming dominant players in the expanding regenerative medicine market in Japan, ” stated Pluristem Chairman and CEO Zami Aberman, in the December 21, 2015 news release.
According to the news release, “The trial will collect data on 75 patients suffering from CLI. These patients will be randomized into three groups of 25.
- Group one will receive an initial 150 million PLX-PAD cell dose followed eight weeks later by a second 150 million cell dose.
- Group two will be treated with an initial 300 million PLX-PAD cells followed eight weeks later by a second dose of 300 million cells.
- Group three will receive two doses of placebo.
The cells will be injected into a leg muscle using a standard syringe. Efficacy and safety will be determined from outcomes measured nine months after administration of the first dose. The primary efficacy endpoint will be diagnosis of a patient as CLI-free for 60 days. Pluristem expects to submit the formal Clinical Trial Notification (CTN) to the PDMA, based on the agreement reached with the regulatory body, in early 2016. The PMDA is expected to respond officially within 30 days. Earlier in 2015, the PMDA cleared PLX-PAD cells for use in clinical studies in Japan, a prerequisite to conducting this clinical trial.”
Karine Kleinhaus, Divisional VP, North America, told OTW, “Regarding the process, the most challenging part was that we were applying to a new and unique regulatory pathway, and there was no experience to draw on. But PMDA was gracious and easy to work with and we have the utmost respect for their process.”
“Regarding the orthopedic surgeons, this protocol is for CLI, but we would welcome the interest of orthopedic surgeons in the orthopedic indications we are pursuing. We have already completed a phase 2 trial in muscle injury that showed very positive results. Treatment with PLX-PAD cells versus placebo resulted in a 500% improvement in muscle strength in the gluteus medius six months after total hip replacement (p<.0064). There was also a statistically significant improvement in the strength of the gluteus muscle in the opposite, contralateral, non-operated leg, in those treated with PLX-PAD versus placebo, opening up the possibility for PLX-PAD to treat atrophied muscle.”
