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Introgen Therapeutics, Inc. (ticker: ingn, exchange: NASDAQ) News Release
- 6/6/03
Introgen Reports Safety and Clinical Activity for INGN 241
Therapy; Phase 1/2 Study Shows Potency of INGN 241 as
Cancer Cell Killer
WASHINGTON, June 6 /PRNewswire-FirstCall/ -- A report of final phase 1
and initial phase 2 evaluation of Introgen Therapeutics' (Nasdaq: INGN)
anti- cancer drug INGN 241 was presented during a scheduled press
conference at the annual meeting of the American Society of Gene
Therapy. The trial results in patients with solid tumors demonstrate that
INGN 241 is well tolerated, that the agent is biologically active, and
importantly, minimal toxicities are associated with the treatment.
Introgen's chief medical officer, Dr. James Merritt, was invited to present
these data at the press conference.
"Introgen's belief that INGN 241 is one of the most promising anti-cancer
gene drugs in clinical development today has been validated repeatedly
in our studies, and we are gratified that our research has been
highlighted as newsworthy by the ASGT review committee," said Dr.
Merritt.
Previous studies show that INGN 241 causes cancer cells to die and the
MDA-7 protein released from the tumor cells may stimulate the immune
system to attack additional metastatic tumor cells. A phase 1 study
confirmed that INGN 241 is safe and that the MDA-7 protein is active,
and importantly, has a wide area of biological effect within injected
tumors. In the phase 1 dose- escalating study, tumors from patients
treated with the higher dose of the therapy were observed to have the
MDA-7 protein in up to 80 percent of cells. The cancer therapeutic has
the potential to trigger the human immune system to attack cancer
cells. Increases in killer T cells were observed following treatment. To
date, in the phase 2 study, although no tumor has responded after a
single dose, tumors in two patients regressed after as few as two doses.
Complete regression was noted in a melanoma. Regression was also
noted in a case of squamous cell cancer.
INGN 241 consists of the human mda-7 gene in Introgen's proprietary
adenovirus vector. The mda-7 gene was discovered by the laboratory of
Dr. Paul B. Fisher, professor of clinical pathology and the Michael and
Stella Chernow Urological Cancer Research Scientist in the Departments
of Neurological Surgery, Pathology and Urology at Columbia University.
Introgen holds an exclusive worldwide license from the Corixa
Corporation.
Introgen is a leading developer of biopharmaceutical products designed
to induce therapeutic protein expression using non-integrating gene
agents for the treatment of cancer and other diseases. Introgen
maintains integrated research, development, manufacturing, clinical and
regulatory departments and operates a commercial-scale, CGMP
manufacturing facility.
Certain statements in this press release that are not strictly historical
may be "forward-looking" statements, which are based on current
expectations and entail various risks and uncertainties. Such
forward-looking statements include, but are not limited to, those relating
to Introgen's future success with its clinical development program with
INGN 241 for solid tumors. There can be no assurance that Introgen will
be able to commercially develop gene- based drugs, that necessary
regulatory approvals will be obtained or that any clinical trials or studies
undertaken will be successful or that the proposed treatments will prove
to be safe and/or effective. The actual results may differ from those
described in this press release due to risks and uncertainties that exist in
Introgen's operations and business environment, including, but without
limitation, Introgen's stage of product development and the limited
experience in the development of gene-based drugs in general,
Introgen's dependence upon proprietary technology and current
competition, history of operating losses and accumulated deficits,
reliance on collaborative relationships, and uncertainties related to
clinical trials, the safety and efficacy of Introgen's product candidates,
the ability to obtain the appropriate regulatory approvals, patent
protection and market acceptance, as well as other risks detailed from
time to time in Introgen's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K filed with the SEC
on March 31, 2003 and its quarterly report on Form 10- Q filed with the
SEC on May 15, 2003. Introgen undertakes no obligation to publicly
release the results of any revisions to any forward-looking statements
that reflect events or circumstances arising after the date hereof.
Editor's Note: For more information on Introgen Therapeutics, or for a
menu of archived press releases, please visit Introgen's Website at:
www.introgen.com .
Contact:
Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322
Email: c.burke@introgen.com
SOURCE Introgen Therapeutics, Inc.
-0- 06/06/2003
/CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,
+1-512-708-9310, ext. 322, or c.burke@introgen.com /
/Web site: introgen.com /
(INGN)
CO: Introgen Therapeutics, Inc.
ST: Texas
IN: MTC BIO HEA
SU:
GN-CD
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