Procept Announces Initiation of Several Clinical Trials
Sponsored by the National Cancer Institute
O6-Benzylguanine Chemosensitizer to be Studied in Additional Cancer Indications
CAMBRIDGE, Mass.--(BW HealthWire)--Aug. 23, 1999-- Procept, Inc. (Nasdaq SmallCap:PRCT - news) today announced the
initiation of four new Phase I human clinical trials of its O6-Benzylguanine (``BG') chemosensitizing agent. Although the
objectives are different for each trial, they are generally designed to determine the maximum tolerated dose of BCNU, a
commonly used alkylating agent, in combination with BG. These trials are sponsored by the National Cancer Institute (``NCI') and
will be conducted under the Cooperative Research and Development Agreement (``CRADA') that was executed with the NCI to
further the Phase I and Phase II development of BG.
The first trial is being conducted at the Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve
University (``CWRU') under the direction of Dr. Timothy Spiro for the treatment of breast cancer. This trial is currently open for
enrollment. The second trial is also being conducted at CWRU under the direction of Dr. Gary S. Wood for the treatment of
cutaneous T-cell lymphoma. Three patients have been enrolled and recruitment continues. A third trial is being conducted through
the Pediatric Oncology Group (``POG') under the direction of Dr. Denise M. Adams of the Duke University Medical Center for
treating children with primary central nervous system tumors refractory to standard therapy. Three patients have been enrolled
and recruitment continues. The fourth trial is being conducted at the University of Chicago Medical Center under the direction of
Dr. Mark Ratain. Unlike the other studies, the major objective of this study is to confirm the minimal BG dose that significantly
inactivates the tumor DNA repair protein O6 alkylguanine-DNA alkyltransferase (``AGT') in patients with a variety of surgically
resectable solid tumors. This trial is currently open for enrollment.
``We are very excited about these additional clinical trials,' said John F. Dee, President and CEO of Procept, Inc. ``The NCI and
the many investigators continue to support the clinical development of BG for a variety of cancer indications. In addition to brain
cancer, melanoma, and multiple myeloma, Procept hopes that BG may provide increased efficacy for O6-alkylating agents in other
cancers, such as lung, colon, and breast for which O6-alkylating agents are not commonly used. We hope to initiate this Phase II
program soon.'
BG is a chemosensitizer that is designed to breakdown tumor resistance to a significant class of commonly used chemotherapeutic
agents known as O6-alkylating agents. BG inactivates tumor AGT, a DNA repair protein which interferes with the effectiveness
of certain alkylating agents. Inactivation of AGT in a variety of human tumor cell lines rendered these cells more sensitive to the
cytotoxic effects of several alkylating agents. In preclinical animal studies, treatment with BG increased the anti-tumor activity of
BCNU in brain, colon and prostate cancers. Published human clinical data show that a correlation exists between low levels of
AGT and survival in brain tumor patients treated with BCNU chemotherapy. The dose of BG that effectively inactivates the DNA
repair protein AGT in solid tumors was determined in NCI-sponsored Phase I studies performed at the Duke University Medical
Center, the University of Chicago and the Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve
University. Phase I clinical studies at these institutions are also nearing completion to determine the optimum dose of the
O6-alkylating agent BCNU that can be combined with the previously determined effective dose of BG. Following completion of
these trials, a Phase II development program will be conducted in accordance with the CRADA.
Procept, Inc., located in Cambridge, MA, is a biopharmaceutical company currently engaged in the in-licensing, development and
commercialization of novel drugs with a focus on anti-infectives and oncology. The Company's lead AIDS product, PRO 2000 Gel,
is being developed as a female-controlled topical microbicide for the prevention of HIV infection and other sexually transmitted
diseases. BG is a chemosensitizing agent designed to breakdown tumor resistance and therefore enhance the efficacy of
chemotherapeutic agents in several cancer indications. The proprietary photodynamic therapy compound, Boronated
Protoporphyrin, is designed to be used with lasers to selectively kill fast growing cells and may be suitable to treat cancer,
pre-cancer and various other medical conditions, including age-related macular degeneration, an area of recent excitement. Each
of these compounds is in human clinical trials and two have received government funding and support. The Company continues its
search for new in-licensing and acquisition opportunities.
Certain statements in this press release constitute ``forward-looking statements' that involve risks and uncertainties, including
those arising under the Company's business strategy; the success of the Company in financing efforts; the pursuit of collaborative
arrangements for research and development of product candidates, as well as the pursuit of joint development or licensing
arrangements with pharmaceutical, diagnostic or instrumentation companies; the research or development of particular products,
compounds or technologies; the uncertainty of the results of such development activities and related clinical trials or required
regulatory approvals; and the reliance on collaborative partners and governments for development, regulatory or marketing
activities. |
