- Subject: Introgen Therapeutics, Inc. and M. D. Anderson Cancer...
- From: AOL News <AOLNews@aol.com>
- Date: Tue, 16 Dec 1997 08:52:21 EST
- Organization: AOL (http://www.aol.com)
<HTML><PRE><FONT COLOR="#000000" SIZE=5><B>Introgen Therapeutics, Inc. and M.
D. Anderson Cancer Center Initiate First-Ever Phase I Clinical Trial Utilizing
Adenoviral-p53 Gene Therapy For Prostate Cancer
<FONT COLOR="#000000" SIZE=3></B> AUSTIN and HOUSTON, Texas, Dec. 16
/PRNewswire/ -- Introgen Therapeutics, Inc. and The University of Texas M. D.
Anderson Cancer Center today announced the initiation of a Phase I clinical
trial utilizing INGN 201 (Adenoviral-p53 gene therapy) for the treatment of
prostate cancer.
In 1997, approximately 210,000 new cases of prostate cancer will have been
diagnosed in the United States alone, making it the most common type of cancer
among men. It is also the second leading cause of cancer related mortality in
males. Surgery is effective in early cases, but many patients present with
locally aggressive disease and cannot be cured with either surgery or
radiation therapy, which constitute the most widely used forms of treatment.
Improving treatment options for this category of patient, which has become
more common in recent years due to new screening tests for the disease, is key
to improving outcomes.
David G. Nance, President and CEO of Introgen said, "Prostate cancer
affects an enormous number of men, and that number is increasing annually.
Current treatment options are associated with serious side effects and are of
limited efficacy. Our completed clinical studies in head and neck and non-
small-cell lung cancers have demonstrated evidence of clinical activity and an
excellent safety profile. We are optimistic that adenoviral-p53 gene therapy
will prove to be a valid approach to treating prostate cancer."
The Phase I trial, led by Christopher Logothetis, M.D. Principle
Investigator, is being conducted at The University of Texas M.D. Anderson
Cancer Center and will expand to additional sites in 1998. The trial will
enroll 30 patients.
"This study will determine the safety and antitumor activity of increasing
doses of INGN 201 injected directly into the prostate gland in patients with
locally aggressive tumors," said James A. Merritt, M.D., Vice President of
Clinical Affairs at Introgen. "If successful, this treatment approach could
make more of these patients amendable to surgical cure in the future. INGN
201 has also been shown to increase the potency of radiation therapy in model
systems. This offers an alternative or complementary path toward ultimate
clinical use in these patients."
Other p53 Trials In September 1997, Phase II clinical trials in head
and neck cancer using INGN 201 were initiated. Preliminary Phase I results
for head and neck cancer, as well as for non-small-cell lung cancer trials
were announced at the 33rd Annual Meeting at the American Society of Clinical
Oncology in May. These results demonstrated tumor stabilization and regression
in select patients with both mutated and normal p53 and no clinically
significant toxicities were seen in any patient.
Role of p53 Over 50 percent of all cancers have a mutation of the p53
gene. p53 is a tumor suppressor gene, encoding a protein that responds to
damage involving a cell's DNA. The protein activates one of two pathways in
the damaged cell: a growth-arrest pathway in which cell division is halted
until the DNA damage has been repaired; or a cell-suicide or apoptotic
pathway, in which heavily damaged cells undergo programmed cell death.
Each of these pathways prevents mutations from being passed on to daughter
cells and provides an important break in the development of certain cancers.
These protective pathways become non-functional when a cell's own p53 genes
are lost or mutated. Data produced in clinical studies indicates that
adenoviral-p53 therapy may benefit cancer patients bearing tumors with or
without p53 mutations.
Introgen Therapeutics/The University of Texas M. D. Anderson Cancer Center
Introgen Therapeutics, Inc., a privately held Texas-based company, is a leader
in the development of gene-based cancer therapeutics. Introgen was formed to
commercialize anti-cancer technology developed at The University of Texas M.
D. Anderson Cancer Center in Houston, Texas. Introgen's primary focus is on
the development of in vivo gene therapy products for a variety of cancers and
the development of vectors used to deliver genetic material constructs.
Introgen and its partner for p53 products, RPR Gencell, are planning to
conduct numerous Phase I and Phase II clinical trials in various indications
in the United States, Europe and Japan, and recently launched an international
Phase II trial in head and neck cancer.
This study was partially funded by an award to M.D. Anderson Cancer Center
from CaP CURE. CaP CURE, the Association for the Cure of Cancer of the
Prostate, is a public charity that provides nearly $20 million annually for
research to find a cure for advanced prostate cancer.
SOURCE Introgen Therapeutics, Inc.
CO: Introgen Therapeutics, Inc.; University of Texas M.D. Anderson Cancer
Center; Association for the Cure of Cancer of the Prostate
ST: Texas
IN: HEA MTC
SU:
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