Here's the PRNewswire version:
Ligand's Panretin(TM) Capsules Demonstrate Positive Results In Two Phase
II Trials for AIDS-Related KS
Tuesday, February 10, 1998 05:15 PM
>
NDA Planned 1999
SAN DIEGO, Feb. 10 /PRNewswire/ -- Ligand (LYE-gand) Pharmaceuticals Inc. (Nasdaq:
LGND) announced today that analyses of two Phase II trials with Panretin(TM) Capsules in
patients with AIDS-related Kaposi's sarcoma (KS) showed patient response rates of 38 percent
and 37 percent.
The two studies were similar in design, with one conducted by the AIDS Malignancy Consortium
(AMC) sponsored by the National Cancer Institute (NCI) and the other conducted directly by
Ligand. Both were multicenter, open label studies designed to evaluate the safety and efficacy of
Panretin Capsules in patients with AIDS-related KS.
"With positive results from these two studies, and a New Drug Application (NDA) filing for our
topically applied Panretin Gel on track for later this quarter, Ligand will intensify its focus on bringing
Panretin Capsules to market for people with AIDS-related KS," said David E. Robinson, Ligand
Chairman, President and Chief Executive Officer.
"Because there are many more KS patients with no available alternative oral treatments to
chemotherapy than there are patients with acute promyelocytic leukemia (APL), we will restructure
our more slowly accruing APL program by terminating one of our ongoing Phase III studies, and we
will channel our resources into the KS indication with a goal of completing an NDA filing in 1999,
our targeted timetable," Mr. Robinson said.
In the studies, Panretin Capsules were administered once daily at doses increasing from 60 mg/m2
to 100 mg/m2/day. Study participants had to have biopsy proven KS associated with AIDS and at
least five to six skin lesions that were assessed every two weeks for response. Response was
determined by applying the standard AIDS Clinical Trial Group (ACTG) criteria for complete and
partial response based on the indicator lesions. The protocol-defined evaluation period was 16
weeks.
The study conducted by the AMC has enrolled 66 patients at eight sites. The overall response rate
at final analysis through the 16-week evaluation period for patients meeting the criteria for evaluation
was 38 percent (19 of 50) including one complete responder. Drug side effects were generally
manageable, with some patients requiring dose reductions with headache, dry skin, rash, alopecia,
peeling/flaking, and hyperlipidemia as the most common events.
The study conducted by Ligand enrolled 57 men at five study centers. The overall response rate for
all patients (21 of 57) was 37 percent, and for patients who met the protocol defined criteria for
evaluation the overall response rate was 57 percent (21 of 37). One patient demonstrated a
complete response. Almost all patients were on highly active antiretroviral therapy (HAART),
including at least one protease inhibitor, prior to the start of Panretin Capsules therapy. The side
effect profile was similar to that of the AMC study.
"Detailed analyses of both studies are continuing," according to Steven D. Reich, M.D., Ligand
Senior Vice President, Clinical Research, "and final results of both studies will be reported at
scientific forums starting in April. We are encouraged by the positive findings of these studies.
Future studies are planned to further explore dosing regimens, activity and tolerance," Dr. Reich
said.
Kaposi's sarcoma is the most frequent malignant cancer lesion in patients who are HIV-positive and
is often characterized by multifocal, widespread lesions at the onset of illness, and may involve the
skin, oral mucosa, lymph nodes and visceral organs, such as the lung and gastrointestinal tract. KS
was first described in 1872 by the Austro-Hungarian dermatologist, Moritz Kaposi. Until the HIV
disease epidemic identified with AIDS, KS was a rarely seen tumor.
Panretin Capsules are in two single-agent Phase II trials and in a Phase I trial in combination with
interferon for patients with AIDS-related Kaposi's sarcoma. Phase II trials are ongoing in breast,
ovarian, pediatric cancers, and bronchial metaplasia. Trials in myelodysplastic syndrome and a study
in severe plaque psoriasis have been completed. Ligand expects to be able to determine additional
indications for NDA filings from these studies based on results expected to be announced in 1998.
Panretin Capsules will continue to be studied in patients with APL.
Two pivotal Phase III trials of Panretin(TM) Gel for topical treatment of KS have been completed
to support an NDA filing in the first quarter of 1998. The trials showed response rates of 42 and 35
percent respectively at 16-week assessments, and up to 48 percent response with continued
treatment beyond 16 weeks.
Since 1989, Ligand Pharmaceuticals Incorporated has established a leadership position in gene
transcription technology, particularly intracellular receptor (IR) technology and Signal Transducers
and Activators of Transcription (STATs). Ligand has applied IR and STATs technology to the
discovery and development of small molecule drugs to enhance therapeutic and safety profiles and
to address unmet patient needs in cancer, women's and men's health and skin diseases, as well as
osteoporosis, metabolic, cardiovascular and inflammatory disease.
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 Panretin Capsules, Panretin Gel, or any product in the Ligand
pipeline will be successfully developed, that regulatory approvals will be granted, that patient and
physician acceptance of these products will be achieved, that final results of human clinical trials will
be consistent with any interim results, or that final results will be supportive of regulatory approvals
required to market products or that regulatory filings will be made in the timeframe expected. Ligand
undertakes no obligation to update the statements contained in this press release after the date
hereof.
SOURCE Ligand Pharmaceuticals Inc.
CONTACT: Susan Atkins of Ligand Pharmaceuticals, 619-550-7687 |
