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Introgen Therapeutics, Inc. (ticker: ingn, exchange: NASDAQ)
News Release - 6/2/03
Introgen's Advexin Therapy Halts Tumor Growth in
Advanced Esophageal Cancer Patients
CHICAGO, Jun 2, 2003 /PRNewswire-FirstCall via COMTEX/ --
Two abstracts describing an early stage phase 1/2 clinical
study in esophageal cancer indicated that Introgen
Therapeutics' (Nasdaq: INGN) Advexin therapy was well
tolerated by patients and appeared to slow the advancement
of the disease, the company announced today. These
patients were not eligible for surgery. Additionally, biosafety
studies revealed that Advexin is safe and biologically effective
in the patients treated on the study. These data were
presented and published at the annual meeting of the
American Society of Clinical Oncology.
The preliminary clinical results were reported by the
investigators at Chiba University School of Medicine Hospital in
Japan. (Abstract # 877) The tumors, which were far advanced
and resistant to standard therapies, were injected twice
weekly with Advexin over a two to five month period via local
injection. Seven patients had been treated at the time of this
report and only one patient's disease had progressed during
the evaluation period. Pain and mild fever were the only
recorded side effects. Biologically active p53 protein was
produced within the tumors, as revealed by laboratory
evaluations, which were detailed in the second abstract
reported by the investigators. (Abstract # 1334)
"We are encouraged by the initial data for Advexin in the
treatment of esophageal cancer," said James A. Merritt, M.D.,
Introgen's chief medical officer. "Given the activity and
tolerance shown in these studies, and the dire need for
improving the treatment of this condition, the possibility of
combining Advexin with radiotherapy or radiotherapy plus
chemotherapy is also attractive."
Esophageal cancer is a particularly invasive cancer, which is
usually too far advanced for surgical removal and cure at the
time it is diagnosed. The cancer is notoriously resistant to
therapy, invades the local anatomical structures in the chest,
and most patients have substantial difficulty and pain with
eating and swallowing. While rare in the United States,
esophageal cancer is common in some countries, notably
Japan. The disease is similar to squamous cell cancer of the
head and neck, which is more common in the United States.
Advexin is being studied in two phase 3 studies in advanced
head and neck cancer.
In addition to the esophageal study, Introgen is also
conducting a phase 1/2 study in non-small cell lung cancer at
four other universities in Japan. The Advexin trial represents
the first therapeutic gene drug to receive regulatory approval
for commercial development in Japan. Introgen and its
collaborators recently published the results of a clinical study
of Advexin combined with radiotherapy in patients with locally
advanced lung cancer in which showed that approximately
60% of patients' primary tumors regressed or disappeared
after the combination therapy, as assessed by both biopsies
and by CT scans three months after treatment.
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 ADVEXIN therapy
alone or in combination with other modalities for esophageal
cancer. 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.
C. Channing Burke of Introgen Therapeutics, Inc.,
+1-512-708-9310, ext. 322, or c.burke@introgen.com
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