Longer-Term Use of Panretin Gel for Treatment of Patients with Cutaneous AIDS-Related Kaposi's Sarcoma Improves Response Rate to 56%.
SAN DIEGO--(BW HealthWire)--May 17, 2000
Data Presented at the National Cancer Institutes' Fourth
International AIDS Malignancy Conference
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced study results showing that longer-term use of the Company's Panretin(R) (alitretinoin) gel 0.1% substantially improves response rates in patients with cutaneous AIDS-related Kaposi's sarcoma (KS). These results, based on long-term follow-up from the Company's multicenter Phase III clinical trial, were presented in a poster session at the National Cancer Institutes' Fourth International AIDS Malignancy Conference in Bethesda, MD by Richard C. Yocum, M.D., Ligand's Senior Medical Director, Clinical Research.
"The longer-term topical application of Panretin gel resulted in further, incremental benefit to patients during the follow-up of this Phase III trial after completion of the initial 12 weeks of treatment," noted Dr. Yocum.
"Overall response rate improved over the period to a 56% response rate. These data further demonstrate the significant and clinically meaningful efficacy of Panretin gel as a safe and effective treatment option for patients with cutaneous KS that can be self-applied at home without the need for frequent visits to health care providers."
Study Design and Results
The objective of this analysis was to evaluate the longer-term safety, tolerability and efficacy of Panretin gel in the treatment of patients with AIDS-related cutaneous KS. The Phase III study included a randomized, double-blind, 12-week phase of study that compared Panretin gel to vehicle gel in 268 HIV-positive patients with biopsy-proven KS. Subsequently, 184 patients (all of whom were men) elected to begin open-label treatment with Panretin gel for up to an additional 163 weeks (for a total treatment duration of up to 175 weeks) with applications generally ranging from two times per day to four times per day. Overall response rates (clinical complete and partial responses) were determined by AIDS Clinical Trials Group (ACTG) criteria applied to topical therapy of six representative cutaneous index lesions.
A comparison of the data collected from the blinded-phase to those of the open-label phase showed a substantial increase in patient response rate, from 35% to 56%, and the clinical complete response rate (all index lesions completely resolved) increased from 0.7% to 3.3%. The projected median time to response (greater than 50% improvement) using Kaplan-Meier analysis was 14 weeks, and the projected median time to relapse was 65.1 weeks from initial treatment. Following a maximum of 175 weeks of monitoring, 36 responding patients (33%) relapsed. Of the 29 responding patients who had follow-up assessments after the discontinuation of treatment, 25 (86%) continued to meet the ACTG response criteria over a median duration of 21.9 weeks (range 4.1 to 67.1 weeks).
Adverse events relating to the course of treatment were limited primarily to the site of application and almost all were mild to moderate. The most common adverse events were transient and included rash or redness (51%), pain (26%) and pruritus (itching, 11%). The resolution of these most common adverse events occurred promptly upon discontinuation of treatment (median of 9 to 11 days).
Kaposi's sarcoma was first described in 1872 by the Austro-Hungarian dermatologist, Moritz Kaposi. Until the HIV disease epidemic, KS was a rarely diagnosed tumor. KS is the most frequently occurring AIDS-related malignancy and is often characterized by multifocal, widespread lesions. KS may involve the skin, oral mucosa, lymph nodes and visceral organs, such as the lung and gastrointestinal tract.
In February 1999, Panretin gel was approved by the Food and Drug Administration for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma when systemic anti-KS therapy is not required. Ligand is currently awaiting a response from the European Medicines Evaluation Agency on the Panretin gel Marketing Authorization Application submitted in February 1999 and has received approval to market Panretin gel in Canada.
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 had three drugs approved during 1999 for marketing in the U.S. -- Targretin(R) capsules, ONTAK(R) and Panretin(R) gel -- that are being marketed through its specialty cancer and HIV-center sales force. Targretin(R) gel is currently under review by the FDA for marketing approval in the U.S., and Morphelan(TM) (licensed from Elan) is in late-stage development. 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 shown in clinical trials will be repeated in any patient population; that any development candidate or any compound or product in the Ligand pipeline will be successfully developed; that any regulatory filings will be made; that any regulatory approvals will be granted in a timely manner, or at all; that, if approved, any product will be accepted by physicians for prescribing, by patients for use and by insurance companies / agencies for reimbursement; or that any products will be commercially successful. 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 Ligand's website at http://www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.
Note: Targretin(R)and Panretin(R)are registered trademarks of Ligand Pharmaceuticals Incorporated, and ONTAK(R)is a registered trademark of Seragen, Inc., a wholly owned subsidiary of Ligand. Morphelan(TM)is a trademark of Elan Corporation plc (NYSE: ELN). Full prescribing information for our marketed products may be obtained from Ligand Professional Services by calling toll-free 1-800-964-5836.
Ligand Pharmaceuticals' releases are available on the World Wide Web at www.businesswire.com/cnn/lgnd.htm.
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|Date:||May 17, 2000|
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