Pluristem Therapeutics Inc. PSTI 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 industry.

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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, Sarepta Therapeutics SRPT and Seagen SGEN. 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.

Loss estimates for ALKS for 2022 have narrowed to one cent from a loss of 13 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.

Sarepta’s loss per share estimates for 2022 have narrowed by 61 cents in the past 90 days. SRPT’s earnings have surpassed expectations in all of the trailing four quarters, the average surprise being 21.45%.

Seagen’s loss per share estimates for 2022 have narrowed from $3.50 to $3.49 in the past 30 days. The same for 2023 has widened from $1.41 to $1.43 in the same time frame. 

Earnings of Seagen missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions, the average negative surprise being 40.08%.


 

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