To: Cymeed who wrote (357 ) 12/9/1997 10:07:00 AM From: scott harrison Read Replies (3) | Respond to
SAN DIEGO--(BW HealthWire)--Dec. 9, 1997--DepoTech Corp.
(NASDAQ:DEPO) Tuesday announced that it has begun Phase II clinical
studies of DepoMorphine, sustained-release encapsulated morphine
sulfate being developed to treat acute post-surgical pain.
Based on DepoFoam technology, DepoMorphine is targeted at
patients following a broad range of surgeries, including deep
abdominal, thoracic, and orthopedic procedures.
The Phase II clinical trials are dose-escalation studies that
will assess safety, efficacy and pharmacokinetics of DepoMorphine
administered epidurally to patients prior to a variety of surgical
procedures. A total of 60 to 90 patients will be enrolled in these
studies.
A recently completed Phase I clinical trial showed that
DepoMorphine, when administered in normal volunteers, reached a
maximum tolerated dose of 30 mg. Current treatment with
un-encapsulated morphine sulfate consists of between 2 and 10 mg of
drug over the first 24 hours.
Pharmacokinetic data from preclinical studies and the Phase I
clinical trial indicate that morphine is present in subjects for a
prolonged period following DepoMorphine administration.
DepoMorphine can potentially offer two to three days of pain relief
using a single dose.
"DepoMorphine may offer a new therapeutic alternative in
post-operative pain management," said Edward L. Erickson, DepoTech's
president and chief executive officer. "Initiation of Phase II
trials is an important step towards adding new drugs to DepoTech's
product base."
The DepoFoam drug delivery system is composed of microscopic,
spherical particles that can be used to encapsulate a variety of
medically important compounds. A lipid-based formulation, DepoFoam
particles are non-toxic and biodegradable and, to date, have been
shown to be well-tolerated in patients. When injected into the body,
DepoFoam formulations generally provide sustained release of the
active drug which should allow for less frequent dosing.
DepoTech is a drug delivery company dedicated to the development
and manufacture of innovative, sustained-released therapeutic
products based on DepoFoam technology. Products are being developed
to satisfy medical needs in cancer, infectious diseases, pain
management and other fields. The company has filed a New Drug
Application with the U.S. Food and Drug Administration for its lead
product, DepoCyt, an anti-cancer drug for the treatment of
neoplastic meningitis.
This news release contains forward-looking statements regarding
DepoTech Corp.'s programs. Actual results could differ materially
from those described in this news release as a result of a number of
factors, including, but not limited to the following: There can be
no assurance that any product in the DepoTech product pipeline will
be successfully developed or manufactured, or that final results of
human clinical trials will be supportive of regulatory approvals
required to market products, or that final regulatory approval will
be received in a timely manner, if at all, or that patient and
physician acceptance of these products will be achieved. The
company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this release.
DepoTech is a registered trademark of DepoTech Corp.
Additional written materials and recent releases regarding
DepoTech are available on the World Wide Web at
depotech.com .
CONTACT: DepoTech Corp., San Diego
Edward L. Erickson, 619/625-2424
or
StratiPoint Group
Mike Jackman, 415/388-3216
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: MEDICINE PRODUCT
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