Life Medical Sciences Inc. (Nasdaq NM:CHAI) announced the early termination of the European clinical trial on PILIEL, its topical gel for hair regrowth.
The decision, in part, reflects a revised strategy to concentrate its resources on its more promising products based on its bioresorbable polymer technology for post-surgical adhesion prevention. The company said it is actively negotiating with several well-established companies regarding the licensing and distribution of its adhesion prevention products and expects to execute an agreement during the first quarter of 1998.
According to Life Medical Sciences President and Chief Executive Officer Robert P. Hickey: “We felt we had sufficient information to conclude that PILIEL would not yield the desired benefit to the intended male users. Conversely, we have been increasingly encouraged by the clinical and pre-clinical surgical results achieved by our growing family of adhesion prevention products.”
Life Medical Sciences’ first bioresorbable film for adhesion prevention, REPEL, recently demonstrated a high level of efficacy in reducing the extent of adhesion formation after gynecological surgery. The company will soon submit an IDE application to the FDA to initiate U.S. clinical trials on REPEL-CV, another proprietary bioresorbable film specifically designed for use in cardiovascular surgical procedures. The worldwide market potential for REPEL and REPEL-CV alone is estimated at $450 million.
Hickey continued: “We believe there is a substantial opportunity for Life Medical Sciences in the exploitation of our patented bioresorbable polymer technology in areas like adhesion prevention, drug delivery and other medical devices. One of our main objectives is the establishment of a family of products for use in the wide range of surgical procedures where adhesion formation can present a serious post-operative complication.
“We have made impressive progress over the past year on several products including REPEL-CV, which could soon become the first bioresorbable adhesion prevention product to be evaluated in human cardiovascular surgery.”
Life Medical Sciences Vice President and Chief Scientific Officer Dr. Eli Pines said: “Human and financial resources associated with the continuation of the PILIEL trial will be redeployed to proceed more aggressively on advancing REPEL, REPEL-CV and RESOLVE, a viscous solution for gynecological and general abdominal surgery, as well as on developing products for preventing adhesion formation following orthopedic surgery and neurosurgery.”
Recent results from the company’s U.S. pilot clinical trial for REPEL are being used in a CE Mark registration which could permit the sale of REPEL throughout Europe by the first quarter of 1999. The company is also planning to initiate pivotal clinical trials for REPEL in numerous sites in the United States and Europe during the second quarter of 1998.
Life Medical Sciences is engaged in the development and commercialization of innovative and cost-effective medical products for therapeutic applications.
Certain statements in this news release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements.
Such factors include, among others, the following: delays in product development; problems or delays with clinical trials; failure to receive or delays in receiving regulatory approval; lack of enforceability of patents and proprietary rights; industry capacity; industry trends; demographic changes; competitions; material costs and availability; changes in business strategy or development plans; quality of management; availability, terms and deployment of capital; business abilities and judgment of personnel; availability of qualified personnel; changes in, or the failure to comply with, government regulations.
Regrowth Editorial: It is sad to see that Piliel didn’t live up to expectations, especially since it was hyped so often and early. It just goes to show again that early results in small #s of people don’t always work out when tested in large #s of people. Although it is also possible that Piliel did work somewhat effectively and that it was an unpatentable product that made it not pursuing since everybody would be able to clone it. I know there was speculation about this in the past. Now we may not know unless the exact ingredients become known. The even worse prospect is that with Piliel out of the picture and Tricomin possibly next, there is no new hairloss treatment on the horizon in the next few years, although there are things in the pipeline for farther down the road.