|Zogenix Received FDA Approval; Pluristem Announces Significant New Finding from Its Phase I/II Muscle Injury Trial|
|By William Kent|
|Monday, 02 February 2015 20:06|
The new version of Zogenix, Inc.'s (NASDAC: ZGNX) Zohydro ER utilizes BeadTek, which has abuse-deterrent properties. The company has ongoing Human Abuse Liability studies that will be submitted to the FDA in the second half of 2015. The company hopes that they will be able to amend the labeling on the current Zohydro ER label.
On January 30, Zogenix, Inc. (NASDAC: ZGNX) received FDA approval for its reformulated version of Zohydro ER.
Zogenix has stated that it expects to roll out the new formulation of Zohydro ER in the second quarter. It is likely that the company announces a secondary offering in the near future to fund the rollout. On January 20, the company put its S-3 into EFFECT. Under the S-3, the company has the ability to raise up to $100 million through a secondary public offering with Cantor Fitzgerald. According to most recent filings, the company has about $50 million in cash and burns about $80 million.
Long-term, a successful rollout could be a positive, as the new formulation has the potential to bring in larger revenues. The company is also developing Brabafen for Dravet syndrome and Relday for schizophrenia. At the time of approval, approximately 15.5 percent of the float was held short. On December 29, Brean Capital put a $2.50 price target on Zogenix stock.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapies, announced an important new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA). Data showed that six months after surgery the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant (19.4 vs 0.5 Nm, p=0.0114). Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo (9.48 vs 0.46 Nm, p=0.227). Pluristem further announced positive twelve-month safety data from the trial. These findings follow the January 21, 2014 announcement that the study had met its primary efficacy and safety endpoints. The primary efficacy finding was the change in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg at six months after total hip replacement. There was a large and statistically significant improvement in patients who were injected with 150 million cells versus those who received placebo (31.1 vs 5.4 Nm, p=0.0067).
The study's Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité – Universitaetsmedizin Berlin, Germany, commented "I am impressed with the magnitude of the effect seen in the treated and contralateral legs. PLX cells demonstrated good safety and these newest findings suggest that intramuscular injection of PLX cells might potentially improve overall muscle functionality."
Zami Aberman, Chairman and CEO, stated "It is very encouraging to have a large and statistically significant effect of PLX-PAD cells on our primary efficacy endpoint and also the unexpected finding of increased muscle strength in the non-operated leg. Although additional confirmatory studies are needed, these findings support our previous studies in which we showed that injection of PLX-PAD cells into muscle generates a systemic effect. The findings also open up new possibilities for the potential use of PLX-PAD cells. Based on these results, we intend to continue to develop PLX-PAD in orthopedic indications including sports injuries and muscle trauma, as well as muscle wasting and rehabilitation."
The Phase I/II trial was a randomized, double blind, placebo controlled study conducted at the Orthopedic Clinic of the Charité – Universitaetsmedizin Berlin jointly with the Berlin-Brandenburg Center for Regenerative Therapies under the auspices of the Paul-Ehrlich-Institute (PEI), Germany's health authority. The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty using the transgluteal approach. Post-operative healing is crucial for joint stability and function. The 20 patients in the study were randomized into three treatment groups. Each patient received injections in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells (n=7), the second was administered 300 million PLX-PAD cells (n=6), and the third received placebo (n=7). The primary efficacy endpoint was clearly met and the safety profile at 12 months was excellent.
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