Expression Genetics, Inc.,
announced today the completion of a Phase I clinical study evaluating the
Company's lead drug candidate, EGEN-001. The study, conducted at The
University of Alabama at Birmingham and Baylor College of Medicine,
evaluated the safety, tolerance, preliminary efficacy, and biological
activity of the EGEN-001 in 13 patients with advanced recurrent epithelial
ovarian cancer. The product, utilizing the Company's proprietary
TheraPlas(R) delivery technology, is composed of interleukin-12 (IL-12)
gene expression plasmid formulated with a biocompatible delivery polymer
and is designed to increase local concentration of IL-12 protein. IL-12 is
a potent anti-cancer cytokine which works by enhancing the body's immune
system against cancer and inhibiting tumor blood supply. EGEN-001 for
treatment of ovarian cancer has been granted Orphan Drug Status by the FDA.
The Phase I clinical trial was an open-label dose escalation study
involving four dose levels of EGEN-001 administered intraperitoneally by
four weekly infusions in chemotherapy-resistant advanced stage recurrent
ovarian cancer patients. The treatment was well tolerated with no apparent
dose- related trends in clinical laboratory, ECG, or vital sign parameters.
General observations included abdominal cramping, mild to moderate
peritonitis, nausea, and mild elevation of body temperature. These data
demonstrate that this IL-12 gene therapeutic is safe for intraperitoneal
administration in ovarian cancer patients.
Several clinical and biological parameters were evaluated as secondary
endpoints of this study. Tumor burden of patients was monitored during
treatment and results show 31% of patients showed stable disease. To date,
the overall median survival is over 12.2 months with 7 out of 13 patients
still surviving. There appeared to be some trend with respect to clinical
benefit in the patients treated with higher dosages. IL-12 plasmid was
detectable in peritoneal fluid of all evaluable patients and in blood
samples of only a few patients at considerably lower level, suggesting that
the plasmid delivery following EGEN-001 administration was localized at the
delivery site, a major advantage of EGEN-001 therapy over recombinant
protein therapy. The IP administered EGEN-001 was biologically active since
it increased the peritoneal levels of interferon-gamma, the predominant
cytokine activated by IL-12, in all patients.
"We are quite pleased with the safety profile of EGEN-001 observed in
this initial clinical trial and are encouraged by some of the preliminary
efficacy and activity results we have seen resulting from the
administration of EGEN- 001 monotherapy in advanced ovarian cancer
patients," said Dr. Danny H. Lewis, CEO of Expression Genetics. "We have
completed the necessary regulatory process and expect to immediately begin
enrollment of patients in our next study which will combine EGEN-001
administration with conventional chemotherapy in platinum-sensitive
recurrent ovarian cancer patients."
The lead investigator, Ronald Alvarez, M. D., Director of Gynecologic
Oncology, The University of Alabama at Birmingham, stated, "We are
encouraged by the initial clinical results of this trial and look forward
to moving ahead with expanded clinical testing of EGEN-001 in order to
evaluate the safety of this experimental drug in combination with
paclitaxel and platinum based chemotherapy treatment regimens."
About Ovarian Cancer
Ovarian cancer accounts for approximately 4 percent of all women's
cancers and is the fourth leading cause of cancer-related death among women
in the U.S. The American Cancer Society statistics for ovarian cancer
estimate that there will be 22,430 new cases and 15,280 deaths in 2007. The
death rate for this disease has not changed much in the last 50 years.
Ovarian cancer has the highest mortality of all cancers of the female
reproductive system. This cancer is often diagnosed at an advanced stage
after the cancer has spread beyond the ovary. Over $2 billion is spent in
the U.S. each year on treatment of ovarian cancer.
About Expression Genetics, Inc.
Expression Genetics, Inc. (EGEN), with laboratories and headquarters in
Huntsville, Alabama is a privately held biopharmaceutical company focused
on developing therapeutics for the treatment of human diseases including
cancer and cardiovascular disease. The Company specializes in the delivery
of therapeutic nucleic acids (DNA and RNAi) and proteins aimed at specific
disease targets. The Company has a significant intellectual property
position in biocompatible polymers, their combination with DNA, and their
therapeutic applications. EGEN has research pipeline products aimed at
treatment of various cancers and cardiovascular disease. These projects
involving siRNA, shRNA, tumor antigens, and angiogenic genes are in early
stages. EGEN has collaborations with outside investigators, biotech
organizations, and universities on various projects in these areas.
Safe Harbor for Forward-Looking Statements
Certain statements contained in this press release may be deemed to be
forward looking statements under federal securities laws and Expression
Genetics intends that such forward-looking statements be subject to the
safe harbor created thereby. Expression Genetics does not undertake an
obligation to publicly update or revise any forward looking statements,
whether as a result of new information, future events or otherwise. Actual
events or results may differ from our expectations as a result of a number
of factors, including but not limited to uncertainties in clinical trials
and product development programs, ability and success level of the Company
in securing adequate capital for operations, market place acceptance of any
resulting product and other factors common to biotechnology research and
development. There can be no guarantee that any product in our pipeline
will be successfully developed.
Expression Genetics, Inc.
egencorp
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