Subject:
CA-LIGAND-PHARM - BW0573 12-15-99
Date:
Wed, 15 Dec 1999 17:22:37 -0500 (EST)
From:
"BusinessWire@Bizwire.com"<NewsRoom@bizwire.com>
DEC 15,1999 14:18 PACIFIC 17:18 EASTERN
( BW)(CA-LIGAND-PHARM)(LGND) Ligand Pre-Clinical Study Results for
Targretin Published in ''Journal of the National Cancer Institute''
Business Editors/Health & Medical Writers
SAN DIEGO--(BW HealthWire)--Dec. 15, 1999--
Suggests Targretin(R) May be Useful for Breast
Cancer Patients Who Have Failed Tamoxifen Therapy
Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) published in
the "Journal of the National Cancer Institute" results of its third
pre-clinical study of Targretin in breast cancer, showing that
Targretin(R) (bexarotene), when added to tamoxifen therapy, caused
complete or partial regression in 94 percent of animals with
tamoxifen-resistant primary breast tumors.
As a result of the positive indications from multiple
pre-clinical studies, Ligand launched a human Phase II clinical trial
in November 1998 to assess the effectiveness of Targretin capsules in
the treatment of women with advanced breast cancer. Interim results
are now expected in the first half of 2000 from this ongoing clinical
trial.
"Our previous studies, published in 'Cancer Research' in December
1996 and February 1998, have shown the efficacy of Targretin in
pre-clinical models for breast cancer prevention and for the treatment
of well-established breast tumors," said William W. Lamph, Ph.D.,
Ligand Associate Director, Nuclear Receptor Discovery. "This
pre-clinical study showed that a combination of Targretin and
tamoxifen was more effective than treatment with either agent alone,
suggesting that Targretin may also be a useful therapeutic for breast
cancer patients who have failed tamoxifen therapy."
The data published yesterday demonstrated that Targretin, when
added to tamoxifen treatment, caused complete or partial regression in
94 percent of primary breast tumors in animals that had stopped
responding to and hence failed initial tamoxifen therapy. In contrast,
only 33 percent of primary breast tumors that remained on high-dose
tamoxifen therapy but did not receive Targretin exhibited a complete
or partial regression. The majority of tumors that remained on
high-dose tamoxifen therapy alone continued to show progressive
growth, consistent with previous studies showing emergence of
tamoxifen resistance. The combination of Targretin and tamoxifen
showed a significant decrease of 38% in the total number of mammary
tumors per animal compared to only a 6% decrease in total number of
tumors per animal for those animals that remained on tamoxifen therapy
alone. The combination regimen of Targretin and tamoxifen not only
reduced the total number of tumors per animal, but also significantly
decreased primary tumor burden by 68%. In contrast, primary tumor
burden increased by 15% for animals that remained on tamoxifen alone,
consistent with their tamoxifen-resistant characteristics. The data
published yesterday also demonstrated that 51 percent of mammary
tumors that had failed to respond to tamoxifen therapy exhibited a
complete or partial regression when Targretin therapy was initiated in
the absence of additional tamoxifen administration.
"The current data clearly demonstrate that Targretin can overcome
tamoxifen failure in this pre-clinical model and may provide a
rationale for combining Targretin with tamoxifen after mammary tumors
have failed initial tamoxifen therapy," said Dr. Lamph.
Ligand has filed a New Drug Application (NDA) with the U.S. Food
and Drug Administration (FDA) for Targretin capsules to treat patients
with cutaneous T-cell lymphoma (CTCL) and is conducting Phase II
studies in breast cancer. Ligand met with the FDA's Oncologic Drugs
Advisory Committee on December 13 to review the NDA submission of
Targretin capsules to treat patients with CTCL, and the FDA is
expected to complete its review of the NDA in December 1999.
The results of the pre-clinical study were presented previously
at the American Association for Cancer Research (AACR) 90th Annual
meeting in Philadelphia, and more recently the initial analysis of
this data was presented at the National Surgical Adjuvant Breast and
Bowel Project (NSABP) annual conference in Washington, D.C.
Additional data presented earlier this year at both the AACR
meeting in Philadelphia and at the 81st Annual meeting of the
Endocrine Society in San Diego by Veena Agarwal, Ph.D., a Ligand
research scientist, demonstrated that, in this pre-clinical model,
Targretin administration altered cellular differentiation within the
tumor and that this altered differentiation correlated with mammary
tumor regression.
Targretin, also known as LGD1069 (bexarotene), a synthetic
retinoid analogue discovered by Ligand scientists, selectively
activates a subclass of retinoid receptors called Retinoid X Receptors
(RXR), which play an important role in the control of cellular
functions.
Ligand Pharmaceuticals Incorporated
Ligand Pharmaceuticals Incorporated discovers, develops and
markets new drugs that address critical unmet medical needs of
patients in the areas of cancer, skin diseases, and men's and women's
hormone-related diseases, as well as osteoporosis, metabolic disorders
and cardiovascular and inflammatory diseases. Ligand's first two drugs
-- Panretin(R) gel and ONTAK(R) -- were approved for marketing in the
U.S. in early 1999 and are being marketed through its specialty cancer
and HIV-center sales force in the U.S. Four additional
oncology-related products are in late-stage development, including
Targretin(R) capsules, Targretin(R) gel, Panretin(R) capsules, and
Morphelan(TM) (licensed from Elan). Ligand's proprietary drug
discovery and development programs are based on its leadership
position in gene transcription technology, primarily related to
Intracellular Receptors (IR) and Signal Transducers and Activators of
Transcription (STATs).
This news release may contain certain forward looking statements
by Ligand and actual results could differ materially from those
described as a result of factors including, but not limited to the
following. There can be no assurance that results from more advanced
clinical trials will be consistent with earlier results, that drug
candidates will show efficacy in all indications currently being
studied, that final results will be supportive of regulatory approvals
required to market products, that regulatory filings will be made in a
timely manner, that regulatory approvals will be received in a timely
manner or at all, or that patient and physician acceptance of these
products will be achieved. Additional information concerning these and
other factors affecting Ligand's business can be found in press
releases as well as in Ligand's public periodic filings with the
Securities and Exchange Commission, available via our website at
ligand.com. Ligand disclaims any intent or obligation to
update these forward-looking statements beyond the date of this
release.
Panretin(R) and Targretin(R) are registered trademarks of Ligand
Pharmaceuticals Incorporated, and ONTAK(R) is a registered trademark
of Seragen, Inc., a wholly owned subsidiary of Ligand.
Ligand Pharmaceuticals' releases are available on the World Wide
Web at www.businesswire.com/cnn/lgnd.htm.
--30--jf/sd* lc/sd
CONTACT: Ligand Pharmaceuticals Incorporated
Paul V. Maier, 858/550-7573 |
