Here's one of the press releases:
ALRT Reports Final Phase I II Data and Interim Control Group
Assessment of Phase III Panretin(TM) Topical Gel in Kaposi's Sarcoma
Presentations Today At Hambrecht & Quist
SAN FRANCISCO, Jan. 7 /PRNewswire/ -- Allergan Ligand Retinoid
Therapeutics, Inc. (ALRT) (Nasdaq: ALRIZ) announced here today two
milestones in its clinical trials of Panretin(TM) (ALRT1057 -
9-cis-retinoic acid) Topical Gel in (cutaneous) Kaposi's sarcoma
(KS).
"The final results of the Panretin Topical Phase I/II trials are
consistent with interim results presented by investigators at the
XIth International AIDS conference in Vancouver in July," according
to Steven D. Reich, MD, Senior Vice President, Clinical Research,
Ligand Pharmaceuticals, responsible for the conduct of ALRT cancer
trials. "And, we have concluded that the data from the study will
be useful to support a new drug applicationon (NDA) based upon the
ongoing Phase III pivotal trial which, if successful, ALRT plans to
file with the Food and Drug Administration (FDA) in the fourth
quarter of 1997."
ALRT also reported on the interim control group assessment of
its Phase III trial of Panretin Topical Gel in KS. "Based on the
first 100 patients completing the blinded portion of the study (up
to 16 weeks), the control response is equal to or below 10%," Dr.
Reich said. "These results are within the range expected and do not
require expansion of the trial however, in order to ensure that we
achieve the desired statistical power on evaluable patients, we
intend to expand the Phase III trial by approximately 35 additional
patients. This should not delay the 1997 filing of the NDA, but it
will add to the patient accrual period which we expect to complete
in the second quarter of this year."
Phase I/IIa Data - "Statistically Significant Activity"
"Statistically significant activity was demonstrated in the
Phase I/IIa intrapatient controlled study," Dr. Reich said.
Patients with AIDS entered in the Phase I/IIa trials with biopsy
proven KS lesions. Patients applied 0.05% or 0.1% gel to multiple
index lesions one to four times daily. Additional index lesions
selected for similar characteristics were monitored as untreated
lesions. Responses were defined by using AIDS Clinical Trial Group
(ACTG) criteria applied to topical therapy. The response rate in
the Phase I/IIa trials which had 115 patients entered was 27% in
treatment lesions (compared with 30% of 63 patients at interim
assessment in July) and 16% in control (untreated) lesions (compared
with 9% in July). About one-quarter of the control lesion
responders had evidence of using active drug on lesions that were
intended to be left untreated. "Because the Phase I/II trials of
Panretin Topical Gel were open label, it was known that there was
the potential for control index lesions to be treated with active
drug," Dr. Reich said.
Phase III Interim Control Group Assessment
"The Phase III study was designed as a randomized, blinded,
placebo- controlled trial in order to decrease the chance of control
lesions being treated with active drug," Dr. Reich noted. "The
interim assessment in the Phase III trial was built into the study
design in order to allow expansion of the sample size to maintain
statistical power of the intent to treat analysis if the response
rate of the control group were greater than 10%. After the first
100 patients had completed the blinded portion of the study with
each patient being followed for up to 16 weeks, an independent
contractor determined the control response rate. The response rate
(less than or equal to 10%) is low enough that the power of the
intent-to-treat analysis to detect a 15% difference [attributed to
treatment] can be maintained with the current sample size. However,
we have decided to enroll an additional 35 patients (15% more) in
order to maintain the statistical power of the evaluable patient (as
per protocol) analysis. While this will add additional time to the
accrual process, we expect the study to be complete in time for a
1997 NDA filing," Dr. Reich said.
Based on the efficacy observed with Panretin(TM) (ALRT1057)
Topical Gel in KS, systemic therapy with Panretin Oral Capsules in
KS is also being assessed. A Phase II study of Panretin Oral
Capsules in KS is now open to enrollment and a Phase II protocol for
Panretin Oral Capsules in KS has been accepted by the newly-formed
AIDS-Related Malignancy Consortium under the sponsorship of the
National Cancer Institute (NCI). Panretin Oral Capsules are in
international Phase II clinical trials for the treatment of various
cancers, including KS, renal cell carcinoma (in Canada and the U.S.
in combination with interferon alpha), non-Hodgkin's lymphoma,
multiple myeloma, acute promyelocytic leukemia, prostate carcinoma
and ovarian carcinoma. A Phase I/II study is currently being
conducted by NCI to evaluate the safety and efficacy of Panretin
Oral Capsules in children with malignancies, and NCI is evaluating
Panretin Oral Capsules in patients with cervical cancer and those
with breast cancer. Phase II trials are also being conducted for
benign indications in psoriasis and proliferative vitreoretinopathy
(PVR) with Panretin Capsules.
Panretin is a proprietary product of Allergan Ligand Retinoid
Therapeutics, Inc., a company that was formed in 1994 to discover
and develop drugs based on retinoids. Retinoids have a broad range
of biological actions, and evidence suggests that retinoids may be
useful in the treatment of skin diseases, a variety of cancers,
including kidney cancer, certain forms of leukemia and other
cancers, as well as eye diseases.
This statement contains certain forward looking statements by
ALRT 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, or any product in the ALRT
pipeline, will be successfully developed, that regulatory approvals
will be granted, that patient and physician acceptance of these
products will be achieved or 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.
NOTE: If you would prefer to receive Ligand's press releases
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SOURCE ALRT
-0- 1/7/97
/CONTACT: Susan E. Atkins, Vice President, Corporate Communications
and Investor Relations of Ligand Pharmaceuticals, 619-550-7687/
/ALRT press releases are available through Company News On-Call
by fax, 800-758-5804, extension 509313, or at
prnewswire.com
(ALRIZ) |
