Life Medical Sciences Terminates PILIEL Trial
By BW HealthWire
December 17, 1997
EDISON, N.J.--(BW HealthWire)--Dec. 17, 1997--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.
--Source: BusinessWire