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Introgen Therapeutics, Inc. (ticker: ingn, exchange: NASDAQ) News Release - 6/4/03
Introgen's INGN 241 Therapy Shows Safety and Clinical Activity in
Phase 1 And Phase 2 Clinical Trials
Data Presented at American Society of Clinical Oncology Meeting
AUSTIN, Texas, June 4 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc.
(Nasdaq: INGN) announced that a cancer patient with metastatic melanoma has
shown regression of multiple tumors including a complete regression of one lesion
after treatment with its mda-7 therapeutic, INGN 241. A report of final phase 1
and initial phase 2 evaluation of INGN 241 was presented during the annual
meeting of the American Society of Clinical Oncology. INGN 241 is Introgen's
second clinical candidate being developed for solid tumors.
Dr. John Nemunaitis, of U.S. Oncology and principal investigator of the phase 1
trial said, "The biological activity of INGN 241 in these patients is very exciting to
see. This data compels us to continue evaluating the INGN 241 agent for
possible treatment of numerous solid tumors."
The administration of INGN 241 was well tolerated in all patients and minimal
toxicities were observed such as fever lasting a few hours. (Abstract # 792) A
key aspect of the phase 1 evaluation was to establish that intratumoral injection
of INGN 241 produced the MDA-7 therapeutic protein both in local and diffusible
forms and the resultant biological effects. Study results further indicate that
MDA-7 protein was detectable up to 4 cm from the injection site. This wide
distribution of MDA-7 protein correlated closely with apoptosis, or cancer cell
killing up to 4 cm away from the injection site, at the external edge of the
injected tumor. Phase 2 evaluation was done with single and multiple doses in
patients with advanced cancers. No tumor responded after a single dose, but
tumors in two patients regressed after as few as two doses. The first lesion in a
patient with metastatic melanoma completely regressed. A second lesion was
injected and this lesion shrank considerably. A third lesion was then treated and
this also responded to INGN 241. During the third set of injections, a distant
melanoma which had not been treated in the study became markedly inflamed,
suggesting a positive immune response. A second patient with melanoma also
showed evidence of tumor regression, as did one patient with squamous cell
cancer.
According to Dr. James Merritt, Introgen's chief medical officer, the clinical
development of INGN 241 was accelerated based on very promising preclinical
and clinical data. The phase 1 study confirmed that MDA-7 protein is active, and
importantly, has a wide area of biological effect. MDA-7 not only functions as a
tumor suppressor, but also as an immune enhancing cytokine which may be
significant as a cancer drug.
"We are in the process of designing a pivotal clinical program for this agent," said
Dr. Merritt.
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
for all gene therapy applications 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 and melanoma. 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- 06/04/2003
/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
ST: Texas
IN: MTC BIO
SU:
JS-AW
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