Pluristem Therapeutics Inc. has announced top-line results from its multinational, double-blind, placebo-controlled phase III study of muscle regeneration following hip fracture surgery.
This is a global, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of intramuscular administration of allogeneic PLX-PAD cells in patients undergoing hip arthroplasty following a fracture. In the United States, Europe and Israel, 240 patients were enrolled in clinical study sites.
The study did not meet the primary endpoint, which was the Short Physical Performance Battery (SPPB) test at week 26. This is a series of physical performance tests used in older persons to assess lower extremity function and mobility
Patients treated with PLX-PAD cells showed an increase of 3.2 kg from reference (week 6) to week 26 compared to 1.3 kg in the placebo group, a 2 kg difference in the injured leg. Patients also showed an increase of 5.01 kg from reference (week 6) to week 52 compared to 0.86 kg in the placebo group, a 4 kg difference.
Patients treated with PLX-PAD cells showed an increase of 2.3 kg from reference (week 6) to week 26 compared to 0.51 kg in the placebo group, a 1.8 kg difference in the injured leg. Patients showed an increase of 3.3 kg from reference (week 6) to week 52 compared to a decrease of 0.7 kg in the placebo group, a 4 kg difference.
Consequently, Pluristem will seek further regulatory advice to find a way to bridge the gap between the clear impact on muscle strength and the functionality score.
Pluristem tanked 10.92% following the news. The stock has declined 27.4% this year so far compared with the fall of 20.6% for the
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The results from the late-stage study disappointed investors.
We note that PLX-PAD is also currently being studied in an investigator-initiated phase I/II study conducted by Tel Aviv Sourasky Medical Center (Ichilov Hospital) for the treatment of steroid-refractory chronic graft versus host disease (cGvHD).
Zacks Rank & Stocks to Consider
Pluristem currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the same space are
Alkermes ( ALKS Quick Quote ALKS - Free Report) , Sarepta Therapeutics ( SRPT Quick Quote SRPT - Free Report) and Seagen ( SGEN Quick Quote SGEN - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank#2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
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