Navigation Links
BioSpecifics Technologies Corp. Announces Top-Line Phase 2b Results for XIAFLEX(TM) for Treatment of Peyronie's Disease
Date:12/16/2009

LYNBROOK, N.Y., Dec. 16 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced top-line efficacy and safety results from a Phase 2b clinical trial of XIAFLEX(TM) for the treatment of Peyronie's disease. Peyronie's disease is characterized by the presence of inelastic collagen on the shaft of the penis, which can distort an erection and make sexual intercourse difficult or impossible in advanced cases. The Phase 2b study, conducted by the Company's partner, Auxilium Pharmaceuticals, Inc., was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients' sexual quality of life using the Peyronie's disease Patient Reported Outcome (PRO) questionnaire. Overall, XIAFLEX demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvature (p=0.001) and the PRO Peyronie's disease bother domain (p=0.046). There was no statistically significant change in mean scores between XIAFLEX and placebo in the PRO penile pain, intercourse discomfort or intercourse constraint domains. XIAFLEX was well-tolerated and the most common treatment related adverse events in the Phase 2b study were consistent with adverse events reported in previous Peyronie's disease trials with XIAFLEX, which included injection site bruising, edema and pain.

"Peyronie's disease can be psychologically devastating and patients have very limited and undesirable treatment options today," commented Thomas L. Wegman, President of BioSpecifics. "We look forward to progress in the clinical program for XIAFLEX in Peyronie's disease in 2010."

In patients who received XIAFLEX, a mean improvement of 29.7% in penile curvature from baseline to 36 weeks was seen (54.4 to 38.2) vs. an 11.0% mean improvement in curvature seen in placebo patients (50.6 to 45.1); (p=0.001). In patients who received XIAFLEX, 60.5% of patients achieved the endpoint of at least a 25% reduction in angle of curvature vs. 25.0% of placebo patients achieving at least a 25% reduction in angle of curvature. In the PRO Peyronie's disease bother domain, the overall XIAFLEX treatment arm experienced a benefit in mean change in score from baseline to 36 weeks that was significantly better than the overall placebo arm benefit (p=0.046). Auxilium Pharmaceuticals Inc. expects to meet with the U.S. Food and Drug Administration (FDA) in the second quarter of 2010 to further discuss these results.

The Phase 2b study was a randomized, double-blind, placebo-controlled trial that was designed to assess the safety and efficacy of XIAFLEX when administered two times a week, every six weeks, for up to three treatment cycles (2 x 3). The study was conducted at 12 sites throughout the U.S., and 145 patients were monitored for 36 weeks following the first injection, with 109 patients receiving XIAFLEX as a series of intralesional injections and 36 receiving placebo (3:1 ratio) in the study. The treatment and placebo arms were also randomized to test for a benefit with the addition of penile modeling versus no modeling (1:1). Modeling refers to massaging of the plaque and is intended to maximize the enzymatic effect of the XIAFLEX injection in the plaque.

The trial was designed to measure the improvement in penile curvature and complete the validation of disease PRO, which measured four domains of patients' sexual quality of life over a period of 36 weeks: penile pain, Peyronie's disease bother, intercourse discomfort and intercourse constraint.

To qualify for the study, patients must have been diagnosed with Peyronie's disease for longer than six months, have stable disease, be able to maintain a rigid erection and have a penile contracture between 30 and 90 degrees. Patients were stratified by the degree of penile curvature (i.e. 30 degrees to 60 degrees versus 60 to 90 degrees).

About Peyronie's Disease

Peyronie's disease is characterized by the presence of inelastic collagen on the shaft of the penis, which can distort an erection and make sexual intercourse difficult or impossible in advanced cases. Significant psychological distress has been noted in sexually active patients with Peyronie's disease. Currently, there are no effective pharmaceutical therapies for this ailment.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for eleven clinical indications, three of which include: Dupuytren's disease, Peyronie's disease, and frozen shoulder (adhesive capsulitis). Its partner Auxilium has announced the acceptance of the Biologic License Application and Priority Review by the FDA's Arthritis Advisory Committee for injectable collagenase XIAFLEX in the treatment of Dupuytren's disease, and on September 16, 2009, the Arthritis Advisory Committee unanimously recommended, by a vote of 12 to 0, that the FDA approve XIAFLEX for the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for marketing XIAFLEX product in Europe.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private

Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, its expected revenue growth, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause its actual results to differ materially from those indicated by such forward-looking statements, including the ability of its partner Auxilium to obtain regulatory approval of XIAFLEX(TM) in the United States for Dupuytren's disease and Peyronie's disease and the ability of Pfizer to obtain regulatory approval of XIAFLEX(TM) in its territory for these same indications, which will determine the amount of milestone, royalty and sublicense income payments it may receive; the amount of earn out payments it may receive from DFB Biotech Inc. and its affiliates; whether Auxilium exercises its option under the companies' license agreement for additional indications; the potential benefits of its existing license and development agreements; its estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company's Form 10-K for the year ended December 31, 2008 and the Form 10-Q for the quarter ended September 30, 2009 and any subsequent reports filed with the SEC. The Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

SOURCE BioSpecifics Technologies Corp.


'/>"/>
SOURCE BioSpecifics Technologies Corp.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. BioSpecifics Technologies Corp. to Present at the Piper Jaffray 21st Annual Health Care Conference
2. BioSpecifics Technologies Corp. Announces XIAFLEX(TM) CORD I Study Published in New England Journal of Medicine
3. BioSpecifics Technologies Corp. to Present at Cowen and Company 29th Annual Health Care Conference
4. BioSpecifics Technologies Corp. Announces Initiation of Phase IIb Trial for Peyronies Disease
5. Hill-Rom Investor Conference Features Business Strategy Updates and New Technologies
6. Greenway Medical Technologies PrimeSuite 2011 Receives CCHIT 2011 Comprehensive Certification
7. The Army Awards Follow-On Contract for Autonomous Airway Management to Energid Technologies
8. New Analytical Training Lab Standardizes on Waters Innovative Technologies to Achieve Educational Goals
9. Remote Technologies Improve Patient Care, Viable Alternative to Intensivist Shortage
10. Mach 7 Technologies Contracted by Singapore General Hospital to Provide State-of-the-Art Patient Image Management Technology
11. CareFusion Announces Six New Pyxis(R) Technologies at the ASHP Midyear Clinical Meeting and Exhibition
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... June 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... innovative inhaled drugs, announced today that it was added ... reconstituted its comprehensive set of U.S. and global ... is an important milestone for Pulmatrix," said Chief Executive ... awareness of our progress in developing drugs for crucial ...
(Date:6/23/2016)... -- Any dentist who has made an implant supported denture ... of them do not even offer this as a viable ... costs involved. And those who ARE able to offer that ... cost that the majority of today,s patients would not be ... , founder of Dental Evolutions Inc. and inventor of Implanova ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on ... today announced that patient enrollment in its ongoing ... Duchenne) has exceeded 50% of its 24-patient target. ... in the third quarter of 2016, and to ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect Plugin ... whole new perspective by using the title layers in ProSlice Levels to split-up ... Levels contains over 30 Different presets to choose from. FCPX users can ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
Breaking Medicine News(10 mins):