John, Here's LGND's press release on the stellar clinicals for oral Targretin for CTCL:
PHASE II/III Data Are Favorable for Ligand's Targretin(TM) Capsules
Multicenter Interim Findings Presented at
European Society for Dermatologic Researchers Meeting
SAN DIEGO, Sept. 29 /PRNewswire/ -- Ligand Pharmaceuticals Inc.
(Nasdaq: LGND) announced that a leading dermatologist reported on Sunday that
41 percent of early and advanced stage cutaneous T-cell lymphoma (CTCL)
patients who had been refractory or intolerant to prior therapy and then
received higher dose Targretin(TM) Capsules (LGD1069) achieved a complete or
partial response. For the group of early stage CTCL patients, 37 percent who
received higher dose Targretin Capsules achieved complete or partial response
compared to none of the patients who received a lower dose of Targretin
Capsules. Findings for patients with advanced stage CTCL who received higher
dose Targretin Capsules showed 43 percent partial response. None of the
advanced stage patients received lower dose Targretin Capsules. The interim
findings for the first 36 patients enrolled in these two multicenter Phase
II/III trials were based on the Physicians' Global Assessment of Response
provided in the protocol. CTCL is a debilitating cancer characterized
primarily by skin lesions that can affect more than 50 percent of a person's
skin surface, making day-to-day living painful and difficult.
According to Madeleine Duvic, MD, Chief of Dermatology at The University
of Texas M. D. Anderson Cancer Center and Professor of Dermatology at The
University of Texas -- Houston Medical School, who presented the interim
findings, "Targretin is very active in CTCL with an acceptable safety profile.
The oral and topical routes of administration offer advantages over parenteral
administration, and are appropriate for both limited topical disease and more
advanced stages of CTCL. Receptor selective retinoids offer patients new
therapeutic alternatives that may be disease specific."
Dr. Duvic presented the findings during a keynote address, "Novel
Therapeutic Approaches to CTCL," at the European Society for Dermatologic
Research Cutaneous Lymphoma meeting in Berlin Sunday, Sept. 28.
The interim findings of the Phase II/III trials included two groups of
patients with refractory or persistent CTCL. The first group included
15 patients with early stage CTCL, seven of whom received low doses
(6.5 mg/m2/day) of Targretin Capsules, and eight who received higher doses
(500 to 650 mg/m2/day). The second group included 21 patients with advanced
stage CTCL who received the higher doses of Targretin Capsules.
Among the eight early stage patients on higher dose Targretin Capsules,
one patient (12 percent) attained complete response (no clinical evidence of
disease); two patients (25 percent) attained partial response (defined as
greater than 50 percent improvement); four patients (50 percent) showed
stabilization of disease; none of the patients showed progressive disease; and
one patient had been treated less than four weeks and was not yet evaluable
for response. Of the seven early stage patients receiving lower doses of
Targretin Capsules, there were no complete or partial responses; one patient
(14 percent) showed stabilization of disease; five patients (71 percent)
showed progression of disease; and one patient was not yet evaluable for
response.
Findings for the 21 patients with advanced stage CTCL who received higher
dose only Targretin Capsules showed nine patients (43 percent) with partial
response; seven (33 percent) who attained disease stabilization; two
(10 percent) who had progression of disease; and three patients who had been
treated less than four weeks and had not yet been evaluated for response.
Patients in both the early and advanced stage groups who received higher
dose Targretin Capsules included one (3 percent) with complete response;
11 (38 percent) with partial response; 11 (38 percent) with stabilization of
disease; two (7 percent) with progression of disease; and four patients not
yet evaluable for response. No responses were noted in patients with the
lower dose, suggesting a dose response.
Two-thirds of the responses were noted to have begun by the time of the
first response assessment, which occurred at week four of treatment. All of
the patient responses to Targretin Capsules are ongoing, with the exception of
one partial response patient who relapsed.
"Although a number of the higher dose patients have required dose
modifications for related side effects, Targretin Capsules have been
reasonably well-tolerated in the study population," according to Richard
Yocum, MD, Medical Director of Clinical Research at Ligand. "The majority of
the higher dose drug-related adverse events consisted of reversible
neutropenia (a reduction of white blood cells) without infectious
complications and elevation of serum triglycerides," Dr. Yocum said.
Targretin is a synthetic retinoid analogue discovered by Ligand scientists
which selectively activates a subclass of retinoid receptors called retinoid X
receptors (RXRs) which play an important role in several cellular activities.
One of the most important of these activities is called programmed cell death,
or "apoptosis," a natural process by which the body rids itself of unwanted
cells. This activity makes Targretin a potentially valuable anti-cancer
agent.
Approximately 1,700 patients are newly diagnosed with CTCL each year in
the U.S. The Company estimates that the prevalence of CTCL in the U.S. is
between 11,000 and 14,000 patients. Currently, patients with refractory or
advanced stages of CTCL commonly undergo cytotoxic chemotherapy or receive
interferon in attempts to control the disease.
An interim assessment of Phase I/II clinical trials for Targretin Topical
Gel in March 1997 showed that 43 percent of CTCL patients achieved clinically
significant improvement for signs and symptoms of the disease, with no related
serious adverse events. The study included 48 patients.
Phase II/III clinical trials for Targretin Capsules in CTCL are being
conducted at approximately 35 study centers and will enroll approximately
120 evaluable patients throughout the U.S., Canada, Europe and Australia. The
Company anticipates filing new drug applications (NDAs) for Targretin Capsules
and Topical Gel upon successful completion of the Phase III studies in the
second half of 1998.
Since 1989, Ligand Pharmaceuticals Inc. has established a leadership
position in gene transcription technology, particularly intracellular receptor
(IR) technology and Signal Transducers and Activators of Transcription
(STATs). Ligand applies IR and STATs technology to the discovery and
development of small molecule drugs to enhance therapeutic and safety profiles
and to address major unmet patient needs in cancer, women's and men's health
and skin diseases, as well as osteoporosis, cardiovascular, inflammatory and
metabolic diseases.
This press release may contain certain forward-looking statements by
Ligand and actual results could differ materially from those described as a
result of certain risks and uncertainties, including, without limitation (a)
that interim results may not be predictive of any final results; (b) that
these or any new products under development by Ligand or any of its partners
may not receive approval from the U.S. Food and Drug Administration or other
authorities to market any of these products; (c) that, there may not be a
market for the drugs, if, in fact, the drugs are approved for marketing. The
Company undertakes no obligation to update these statements for events or
circumstances occurring after the date hereof.
Targretin is the trademark of Ligand Pharmaceuticals Inc.
SOURCE Ligand Pharmaceuticals Inc.
CONTACT: Susan Atkins, Vice President, Corporate Communications
of Ligand Pharmaceuticals, 619-550-7687 |
