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Introgen Therapeutics, Inc. (ticker: ingn, exchange: NASDAQ) News Release - 6/2/03
Introgen's Intrabronchial Advexin Therapy Demonstrates Safety and Clinical
Activity in Bronchoalveolar Lung Cancer
Evidence of Both Local and Systemic Therapeutic Activity Presented at American
Society of Clinical Oncology Meeting
CHICAGO, June 2 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN)
announced that direct intrabronchial instillation of its p53 drug Advexin is remarkably
safe and shows evidence of therapeutic activity in cancer patients with bronchoalveolar
lung carcinoma. These data were presented during the annual meeting of the American
Society of Clinical Oncology by Introgen's collaborator Dr. David Carbone of The
Vanderbilt-Ingram Cancer Center. The phase 1 study was conducted by the Eastern
Cooperative Oncology Group under Introgen's Cooperative Research and Development
Agreement with the National Institutes of Health.
"In view of previously reported activity of Advexin monotherapy and Advexin
radiotherapy combination treatment for advanced lung cancer, this report of clinical
activity with yet another method of delivering Advexin is encouraging" said Dr. Carbone.
In the phase 1 study, 26 lung cancer patients were treated with Advexin which was
delivered via repeated instillations into the bronchial passages, known as bronchoalveolar
lavage. (Abstract # 2492) The therapy was well tolerated in all patients and improved
ability to breathe was noted in 20 percent of the patients who were able to be
evaluated. Shortness of breath is a frequent problem in this form of lung cancer. The
majority of the patients' disease stabilized and the cancer did not continue to grow. One
patient had a partial response as demonstrated by x-ray. Most patients whose disease
stabilized in the area for the lung treated with Advexin experienced progression of
disease in untreated areas of the lung, suggesting that Advexin was active only in the
treated lobes. However, one patient was reported to have had objective shrinkage of
metastatic disease in two distant sites, including the brain, raising the possibility that
local instillation could have more systemic effects.
"We are beginning to study treatment with Advexin in earlier stages of cancer, in
combination with other modalities such as surgery and radiotherapy," said Dr. James
Merritt, Introgen's chief medical officer. "We have shown previously that Advexin is
active as an intratumoral injection in advanced lung cancer. Based on this report we
envisage treating early lung cancers which cannot be injected and have to be treated
by instillation into the bronchial tree," he added.
Cancers of the lung and bronchus will account for 171,900 new cases of cancer in the
United States this year, according to the American Cancer Society. Bronchoalveolar lung
carcinoma (BAC) is characterized by thin sheets of tumor cells growing along the
pulmonary airways and is often resistant to surgery, chemotherapy and radiation.
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 for bronchoalveolar lung carcinoma. 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- 06/02/2003
/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.; American Society of Clinical Oncology;
Eastern Cooperative Oncology Group; National Institutes of Health
ST: Texas, Illinois
IN: HEA MTC BIO
SU:
AW-CT
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