Wednesday, August 29, 2012

Spinifex Announces Positive Phase 2 Results for EMA401 in Postherpetic Neuralgia


MELBOURNE, Australia,
Trial Meets Primary Endpoint: Reduction in Pain
Spinifex Pharmaceuticals, an Australian pain drug development company, today announces positive headline results from the Phase 2 clinical trial of its lead product, EMA401, in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

The clinical trial met its primary endpoint, reduction in mean daily pain score versus placebo over the last week of 28 days of treatment. Results show a statistically significant and clinically meaningful reduction in mean pain intensity from baseline to week 4 for subjects on active treatment when compared to placebo. On an intent to treat basis, the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.34; Placebo: -1.64; p = 0.006.

A significantly greater proportion of patients on active treatment reported a more than 30% reduction in mean pain intensity score compared to baseline (i.e. responder rate) (EMA401: 56.5%; Placebo: 34.1%; p = 0.003), meeting a key secondary endpoint.

EMA401 was generally safe and well tolerated with no serious treatment related adverse events reported.
The double-blind, placebo-controlled randomised trial was recruited at 29 centres in six countries and enrolled 183 patients. More details on the trial design and results can be found in the appendix.

Spinifex will be presenting an overview of the clinical development of EMA401 today at the 14th World Congress of Pain in Milan, a major international meeting organised by the International Association for the Study of Pain (IASP). Full results of the Phase 2 trial are expected to be published in a leading pain clinical research journal.

Dr Milton Raff (Christiaan Barnard Memorial Hospital, Cape Town, South Africa), Principal Investigator for the Study, said: "These headline results are very promising with a clear reduction in pain versus placebo and a good safety and tolerability profile. EMA401 offers an entirely novel approach to the treatment of PHN and could represent a valuable new option in an area where there is a clear need for new medicines. Current treatments for the condition are effective in some patients but a significant proportion either don't respond to therapy and are left with debilitating symptoms or suffer significant side effects."

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BioSpecifics Technologies Corp. Announces Presentation of Additional Phase III Data from XIAFLEX Clinical Trials for Peyronie's Disease at SMSNA/ISSM Joint Annual Meeting


LYNBROOK, N.Y BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe and Eurasia, today announced that additional data will be presented from the Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease conducted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (Auxilium) and known as IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies).

 These data will be presented at two oral presentations at the Sexual Medicines Society of North America (SMSNA)/International Society for Sexual Medicine (ISSM) Joint Annual Meeting on August 27 and 29, 2012 in Chicago, IL.

"These data highlight the psychological severity of this condition, which currently has no FDA-approved pharmaceutical therapy, and complement the positive top-line Phase III results from the two IMPRESS clinical trials that we reported in June," commented Thomas L. Wegman, President of BioSpecifics. "We are excited about the potential for XIAFLEX as the first and only biologic therapy for the treatment of Peyronie's disease and we look forward to Auxilium's submission of the sBLA filing to the FDA by the end of this year."

Peyronie's disease can be a physically and psychosocially devastating disorder that may result in deformity of the penis, sexual dysfunction, pain, emotional distress, and loss of self-esteem and depression.  To measure the impact of Peyronie's disease on a patient, the IMPRESS clinical trials utilized a proprietary Peyronie's Disease Questionnaire (PDQ) developed with the U.S. Food and Drug Administration (FDA). One domain of the PDQ is patient bother, which is the patient-reported bother relating to various aspects of Peyronie's disease including pain or discomfort with erection, appearance of the erect penis, difficulty when attempting intercourse and less frequent intercourse. 

The analysis to be presented at the SMSNA/ISSM meeting focuses on the level of patient bother associated with Peyronie's disease as related to the degree of curvature deformity. As reported by Auxilium:

  • At baseline, results showed that all degrees of curvature deformity evaluated in the studies may be associated with high levels of bother and distress.

  • Specifically, more than half (58 percent) of patients with lesser levels of curvature deformity (30 to 60 degrees) reported that they were "very bothered" or "extremely bothered" about their condition. Additional results showed that 73 percent of patients with curvature deformity of 60 to 90 degrees were also "very bothered" or "extremely bothered" about their condition.

  • A high level of patient-reported moderate to severe distress over Peyronie's disease was also noted among subjects with curvature deformity of 30 to 60 or 60 to 90 degrees (80.5 percent and 90.5 percent, respectively).

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