Here's LGND's latest press release (came out after yesterday' close):
INVESTIGATORS PRESENT INTERIM PHASE I II DATA AT INTERNATIONAL AIDS CONFERENCE ON ALRT1057 TOPICAL RETINOID GEL IN KAPOSI'S SARCOMA 30% Of Patients Achieve Partial or Complete Response VANCOUVER, British Columbia, July 8 /PRNewswire/ -- Madeleine Duvic, MD, Chief of Dermatology at The University of Texas -Houston Medical School, today reported to the medical scientific community at the XIth International AIDS Conference interim results of Phase I/II clinical trials of ALRT1057 (9-cis-retinoic acid) Topical Gel in cutaneous Kaposi's sarcoma (KS). The multicenter trial was designed to assess safety and effectiveness of ALRT1057 Topical Gel. Methods: Dr. Duvic reported interim data on sixty-three (63) AIDS patients with biopsy-proven KS lesions enrolled in a controlled Phase I/II trial at six centers. 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 control lesions. Untreated control lesions could be converted to treatment after 8 to 16 weeks. Investigators measured treated and untreated lesion area and elevation every two to four weeks, documented by standardized serial photography. Partial response (PR) was defined using AIDS Clinical Trial Group (ACTG) criteria applied to topical therapy as a complete flattening of at least 50% of the raised lesions (PR-H), or a 50% decrease in area (PR-A). Results: According to Dr. Duvic, ALRT1057 Topical Gel was welltolerated with minimal peri-lesional irritation and no detectable systemic absorption. Forty-three (43) patients with 179 treated index lesions and 119 control lesions received at least 12 weeks of therapy, or withdrew prior to 12 weeks of therapy. A partial response by either height or area (PR-H or PR-A) was achieved in 13 (30%) of the patients for the group of the treated index lesions vs. 4 (9%) for the control (untreated) index lesion group. At least one treated index lesion responded in 30% of patients 23% of patients had at least 50% of treated index lesions respond 9% had all treated index lesions respond. Responses were seen in patients with a wide range of helper T-cell CD4+ lymphocyte counts, including four (4) with counts below 50/mm3, a subset often refractory to KS therapies. Responses were sustained, with a median patient follow-up of 16 weeks (maximum 42 weeks). Only 4 of 28 lesions relapsed, after a median of 12 weeks of response. Conclusions: Dr. Duvic concluded that ALRT1057 Topical Gel induces responses with tolerable side effects and is capable of producing partial to complete resolution of lesions, even in patients with low CD4+ counts. This is the first topical therapy to be extensively evaluated for KS. ALRT1057 Topical Gel may enable patient-controlled, conservative management for this often disfiguring condition. These data support results of assessment reported previously. Based on the efficacy observed with ALRT1057 Topical Gel in KS, systemic therapy with ALRT1057 Oral Capsules in KS is also being assessed. A Phase II study of ALRT1057 Oral Capsules in KS is now
open to enrollment and a Phase II protocol for ALRT1057 Oral Capsules in KS has been accepted by the newly-formed AIDS-Related Malignancy Consortium under the sponsorship of the National Cancer Institute (NCI). In addition, NCI has plans to evaluate ALRT1057 Oral Capsules in HIV+ patients to examine its ability to help sustain CD4+ levels. ALRT1057 Oral Capsules is beginning 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, ovarian carcinoma, and head and neck squamous cell carcinoma. A Phase I/II study is currently being conducted by NCI to evaluate the safety and efficacy of ALRT1057 Oral Capsules in children with malignancies, and NCI is evaluating ALRT1057 Oral Capsules in patients with cervical cancer and those with breast cancer. A pivotal Phase III clinical trial for KS with ALRT1057 Topical Gel has been launched at multiple centers in the U.S. and Canada. ALRT1057 is a proprietary product of Allergan Ligand Retinoid Therapeutics, Inc. (Nasdaq: ALRIZ), 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. The University of Texas-Houston Health Science Center is dedicated to building a model health sciences center for the 21st century. It is a model built on education, research and care devoted to the maintenance of health and the prevention of disease. The University is located in the world-famous Texas Medical Center and is the state's most comprehensive institution of health sciences. -0- 7/8/96
/CONTACT: Mary Lynn Fernau of The University of Texas, Houston Health Science Center, 713-792-4253 or Susan E. Atkins of ALRT, 619-550-7687/ /Ligand Pharmaceuticals press releases are available through Company News On-Call by fax, 800-758-5804, extension 509313, or prnewswire.com |
