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Introgen Therapeutics, Inc. (ticker: ingn, exchange: NASDAQ) News
Release - 6/3/03
Phase 2 Breast Cancer Study Shows Clinical Responses in
90 Percent of Patients Treated With Introgen's Advexin
Therapy
Advexin Safely Combined with Aventis' Taxotere and
Pharmacia's Adriamyacin
CHICAGO, Jun 3, 2003 /PRNewswire-FirstCall via COMTEX/ --
Introgen Therapeutics, Inc. (Nasdaq: INGN) and its collaborators
at The University of Texas M. D. Anderson Cancer Center made
available preliminary data from a phase 2 study in patients with
locally advanced breast cancer indicating that Advexin can be
safely combined with a two-drug standard chemotherapy regimen
and that 90 percent of the patients had major responses to the
therapy. The data (Abstract # 967) was published in conjunction
with the 39th annual meeting of the American Society of Clinical
Oncology being held in Chicago, IL and is available in the
published proceedings.
Dr. Massimo Cristofanilli, assistant professor of breast medical
oncology at M. D. Anderson, and principal investigator said,
"These patients are typically difficult to treat because of the
advanced nature of their disease. We use neoadjuvant therapy to
shrink the large tumors before surgery and radiotherapy to
improve patient outcomes. Our hypothesis is that Advexin can
improve our current neoadjuvant regimen."
The phase 2 study is evaluating Advexin therapy combined with
systemic Taxotere, marketed by Aventis, and Adriamycin,
marketed by Pharmacia, in locally advanced breast cancer and is
being administered prior to surgery. Locally advanced breast
cancer accounts for 5 to 15 percent of newly diagnosed breast
cancer cases in the United States. After 4 months of neoadjuvant
therapy, patients in the study underwent standard surgery to
remove any residual cancer and then had post operative therapy.
The tumor status was evaluated at the time of surgery. The
primary endpoint of the study was the complete pathological
remission rate at the time of surgery. Ninety percent of the
patients treated had clinical complete responses or partial
responses. Pathological examination revealed only scattered
residual tumor cells. No patients had progressive disease.
"We have seen very few side effects," says Cristofanilli. "A few
patients experienced irritation at the site of injection, but that
lasted for only a couple of days. The fact that we have not seen
any progression is important for patients with breast cancer. This
treatment could eventually be applied to breast cancer patients
with every stage of disease."
"This study is an important part of Introgen's development plan
for Advexin because we are administering the drug in the setting
of primary, multi-modality local therapy of cancer in conjunction
with surgery, chemotherapy, and radiation therapy," said Dr.
James Merritt, Introgen's chief medical officer. "A detailed analysis
of these patients compared to previous patients treated with the
chemotherapy alone is in progress to determine the full measure
of clinical efficacy effect of Advexin in this clinical setting."
Advexin supplies p53 protein in very high concentrations in cancer
tissue which selectively kills cancer cells while not harming the
surrounding normal cells. P53 is a normal constituent of cells and
is known as a tumor suppressor because it provides a powerful
halt signal on cell growth. One of the major roles of this protein is
to recognize when the cell has been damaged by mutation and
stop cell growth to initiate repair. If the cell is heavily damaged
and beyond repair, p53 initiates the cell death pathway to
prevent the cell from growing out of control. Scientists refer to
this process as apoptosis. Apoptosis, or cell death, is a normal
process that the body uses to eliminate damaged cells,
precancerous cells and cells that are no longer necessary.
In about half the cases of aggressive breast cancer, the p53
gene is mutated so that protein is no longer available in proper
amounts to control cell growth. In the cancers where the p53
gene is still normal, the function of the p53 protein can be
disrupted in other ways such as sequestration and rapid decay.
Loss of p53 is associated with more aggressive tumors that are
resistant to chemotherapy and radiation therapy. Loss of p53 is
also associated with early metastasis and decreased survival
rates.
Prospective patients and/or referring physicians who would like to
learn more about the study, should call the M. D. Anderson
Cancer Center Information Line at (800) 392-1611.
About Introgen Therapeutics, Inc.
Introgen is a leading developer of biopharmaceutical products,
such as Advexin, 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.
Introgen holds a license from The University of Texas M.D.
Anderson Cancer Center to commercialize products based on the
p53 and the 3p21.3 family of genes, and has the option to license
future technologies under sponsored research agreements. The
University of Texas System owns stock in Introgen.
Certain statements in this press release that are not strictly
historical may be "forward-looking" statements, which involve 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 for locally advanced
breast 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 on March 31, 2003 and its quarterly report on Form 10-Q
filed 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. For more information about M.D.
Anderson Cancer Center, please visit www.mdanderson.org.
CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,
+1-512-708-9310, Ext. 322, or e-mail, c.burke@introgen.com
SOURCE Introgen Therapeutics, Inc.
C. Channing Burke of Introgen Therapeutics, Inc.,
+1-512-708-9310, Ext. 322, or e-mail, c.burke@introgen.com
mdanderson.org |
