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Ligand's Targretin Gel Shows Promise for Many Chronic Severe Hand Dermatitis Patients
Interim Analysis of 55-Patient Phase I/II Study: 32% of Patients on Targretin Alone Achieved 90% Improvement; 68% of Patients Improved by at Least 50%
SAN DIEGO--(BUSINESS WIRE)--Sept. 5, 2002-- Almost a third of patients with chronic severe hand dermatitis (eczema) who were treated with Ligand's (Nasdaq: LGND - News) Targretin® (bexarotene) gel 1% experienced clinical improvement of 90% or more, according to an interim analysis of a Phase I/II dose escalation study.
In addition, 68% of patients who were treated with Targretin achieved a clinically significant improvement of 50% or more.
"These interim data underscore that Targretin gel therapy may effect significant improvement in severe hand eczema, a common, sometimes disabling condition," said principal investigator Jon Hanifin, M.D., Professor, Department of Dermatology, Oregon Health & Science University. "Severe hand eczema is a difficult disease to treat, and topical steroids, the current standard of care, cause troublesome side effects such as skin atrophy. New therapies are needed in this area, and Targretin gel may play an important role in filling an unmet medical need."
Fifty-five patients with a history of severe or very severe hand dermatitis for at least six months were enrolled in the 22-week, open-label study, which was designed to evaluate safety, tolerability and activity. Most of the patients were refractory to standard treatments for hand dermatitis. Patients were randomized to Targretin monotherapy; Targretin in combination with mometasone furoate, a medium potency topical steroid; or Targretin in combination with hydrocortisone, a low potency topical steroid. By study design, half of the patients were included in the Targretin monotherapy arm and the other half were equally divided into the two steroid combination arms. In order to assess tolerability, all Targretin doses were escalated every two weeks, starting every other day, then once per day, twice per day and, finally, three times per day. The steroidal ointments were applied twice daily.
"The preliminary results from this study are quite encouraging," said principal investigator Debra Breneman, M.D., Associate Professor of Dermatology, University of Cincinnati. "Targretin gel generated response rates in patients with chronic, severe disease that compared favorably to those seen with topical steroids in this patient population. However, it did not exhibit steroid side effects." The investigators evaluated efficacy based on:
Physician's Static Assessment (PSA). This primary, FDA-mandated endpoint, which calls for 90% or greater improvement in signs and symptoms, is equivalent to a clear or almost clear condition on at least two observations 21 days apart.
Physician's Global Assessment (PGA), which calls for 50% or greater improvement in signs and symptoms on at least two observations four weeks apart.
At the time of the interim analysis, 26 patients had completed treatment, 18 of them for the entire 22-week study period. Preliminary efficacy results based on an intent-to-treat analysis of all 55 patients were:
Targretin Gel only Targretin Gel + Targretin Gel +
(28 patients) mometasone hydrocortisone (14)
furoate (13)
PSA (at least 90% 32% 46% 7%
improvement)
PGA (at least 50% 68% 62% 50%
improvement)
Based on PGA, most patients responded to treatment by week 14, but patients continued to have a first response to Targretin monotherapy beyond that time. Patients took longer to achieve the more stringent PSA responses, with responses continuing through week 22, the final week of the study.
Adverse events were localized and generally mild to moderate in severity. Irritation/rash was the most common adverse event, experienced by 20% of patients in the three treatment arms. Three patients withdrew from the study due to adverse events, none of whom were treated with Targretin alone.
All treatment frequencies were tolerated by patients, as measured by compliance with the dose-escalation regimen. More than half of patients escalated their dose of Targretin gel to three times daily and stayed on that dose.
"We are particularly encouraged by these results, and intend to move forward to design and gain FDA agreement on Phase II/III registration trials of Targretin gel in hand dermatitis," said Andres Negro-Vilar, M.D., Ph.D., Ligand's Senior Vice President for Research and Development and Chief Scientific Officer.
About Hand Dermatitis and Targretin Gel
There are many sub-types of hand dermatitis, and many causes. The three most common sub-types are contact (an inflammatory response of the skin to an antigen or irritant), atopic (a chronic itchy condition usually beginning in infancy) and dyshidrotic (a recurrent or chronic relapsing form of vesicular dermatitis involving both surfaces). Hand dermatitis may have a hereditary component. Most hand dermatitis is caused by contact with environmental substances, such as chemicals, soaps and cleaning fluids. Fewer cases are caused by allergic reactions to a wide variety of substances, including foods, plants, metals and cosmetics. Chronic hand dermatitis will repeatedly relapse or flare. It can involve 25-90% of the hands and affect one or both surfaces. Topical steroids are the primary first-line treatment.
Hand dermatitis is a form of atopic dermatitis, which affects an estimated 1.9 million people in the United States. Ligand estimates that the atopic dermatitis market could exceed $1 billion over the next several years.
Targretin gel 1% was granted marketing clearance by the U.S. Food and Drug Administration (FDA) in June of 2000 for the topical treatment of cutaneous lesions in patients with early-stage (TNM Stage 1A and 1B) CTCL who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
About Ligand
Ligand discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, men's and women's hormone-related diseases, osteoporosis, metabolic disorders, and cardiovascular and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology, primarily related to Intracellular Receptors (IRs) and Signal Transducers and Activators of Transcription (STATs).
This news release may contain certain forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Actual events or results may differ from Ligand's expectations. There can be no assurance that results of subsequent studies of Targretin gel in combination with any therapy will confirm results presented here. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available via Ligand's internet site at www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.
Full prescribing information for Ligand's products can be obtained in the United States from Ligand Professional Services by calling toll-free 800-964-5836, or on Ligand's internet site at www.ligand.com.
Ligand Pharmaceuticals' releases are available on the World Wide Web at www.businesswire.com/cnn/lgnd.htm.
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Contact:
Ligand Pharmaceuticals
Michael Watts, Director, Investor Relations and
Corporate Communications
858/550-7850
mwatts@ligand.com
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Source: Ligand Pharmaceuticals |
