Today's press release on ATRAGEN showing it is moving to Phase II trials.
ATRAGEN was recently added to the last Promising Protocols post.
Tuesday July 21, 4:19 pm Eastern Time
Company Press Release
SOURCE: Aronex Pharmaceuticals, Inc.
Aronex Pharmaceuticals Announces Expanded Clinical Development Program For
ATRAGEN(R) Being Evaluated In Non-Hodgkin's Lymphoma
THE WOODLANDS, Texas, July 21 /PRNewswire/ -- Aronex Pharmaceuticals, Inc.
(Nasdaq: ARNX - news), a biopharmaceutical company focused on proprietary
medicines to treat cancer and infectious diseases, announced today an
expanded clinical development program for ATRAGEN(R), its proprietary
liposomal formulation of all-trans retinoic acid (ATRA) for the treatment
of hematologic malignancies and solid tumors. The Company has begun to
evaluate ATRAGEN in a Phase II clinical trial in patients diagnosed with
In addition, enrollment has been completed for the ATRAGEN pivotal Phase II
clinical trials in acute promyelocytic leukemia. The Company anticipates a
year-end 1998 filing of a New Drug Application (an ``NDA'') for this
In commenting on the expanded ATRAGEN clinical development program,
Geoffrey F. Cox, Ph.D., Chairman and CEO of Aronex Pharmaceuticals, said,
``We are very pleased that we have completed enrollment of our pivotal
Phase II clinical trial as planned. The Company believes ATRAGEN could have
potential in a number of further cancer indications. Like oral ATRA,
clinical trials indicate that ATRAGEN acts by inducing tumor cells to
differentiate into mature cells that do not proliferate abnormally. Unlike
oral ATRA, ATRAGEN's liposomal formulation sustains higher blood levels
over long periods of time thus extending the potential effectiveness of the
drug. The Company believes that ATRAGEN could be a complementary treatment
to conventional chemotherapy. A positive clinical impact in one or all of
the identified additional indications would have a substantial impact on
the market potential for ATRAGEN and will help to define the product's
potential future role.''
The Company has initiated a multi-center Phase II study of ATRAGEN in
patients with relapsed or refractory non-Hodgkin's lymphoma. This study
will evaluate the ability of ATRAGEN to induce a response in this
population as well as establish the optimal dose. According to the American
Cancer Society, there are more than 55,000 cases of non-Hodgkin's lymphoma
diagnosed every year. Worldwide, this could be translated into
approximately 100,000 cases. This clinical indication was chosen based on
the in vitro work of Richard Ford, M.D. Ph.D. of the University of Texas,
M.D. Anderson Cancer Center. In the October 1997 issue of Cell Growth &
Differentiation, Dr. Ford showed that ATRAGEN is substantially more potent
than free ATRA in inhibiting the growth of B-cell non-Hodgkin's lymphomas
taken from patients. Other retinoids have shown only modest inhibition of
cell growth and only at considerably higher concentrations. In addition,
ATRAGEN induced a high level of apoptosis (programmed cell death).
The Company's expanded ATRAGEN clinical trial program is expected
eventually to encompass the evaluation of ATRAGEN in a number of other
hematologic malignancies and solid tumors.
Aronex Pharmaceuticals, Inc. is a biopharmaceutical company that develops
and commercializes proprietary innovative medicines to treat cancer and
infectious diseases. Aronex Pharmaceuticals currently has four products in
advanced clinical development, two of which are in an advanced stage, as
well as a pipeline of additional products.
Any statements which are not historical facts, including statements
regarding the Company's clinical development programs and the expected
timing of clinical trials and NDA filings, contained in this release are
forward looking statements that involve risks and uncertainties, including
but not limited to those relating to product demand, pricing, market
acceptance, the effect of economic conditions, intellectual property rights
and litigation, clinical trials, governmental regulation, competitive
products, risks in product and technology development, the results of
financing efforts, the ability to complete transactions and other risks
identified in the Company's Securities and Exchange Commission filings.
SOURCE: Aronex Pharmaceuticals, Inc.