XOMA Announces Results of Two Phase I Clinical Trial Studies for XMP.6
XOMA Announces Results of Two Phase I Clinical Trial Studies for XMP.629 Topical Acne Treatment; Cumulative Skin Irritation and Absorption Studies Show Favorable Results
Business Editors/Health/Medical Writers
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BERKELEY, Calif.--(BUSINESS WIRE)--July 29, 2004--XOMA Ltd. (Nasdaq:XOMA) announced today results from two Phase 1 clinical trial studies with its XMP.629 compound, which is being developed as a topical treatment for mild to moderate acne. Results of the cumulative skin irritation and absorption clinical trial studies show that the XMP.629 acetate gel (0.1%) in healthy volunteers and acne patients causes no significant skin irritation, lacks systemic absorption and shows a reduction in lesion counts as early as two weeks after daily dosing. Results from both studies are being presented at the American Academy of Dermatology (AAD) Summer Meeting in New York City from July 28-31, 2004.
"Currently available topical treatments for acne have numerous efficacy and safety concerns that impact patient compliance. These include antibiotic resistance, long lead-times in seeing measurable treatment results, and various side effects," said Patrick J. Scannon, M.D., Ph.D., XOMA's senior vice president, chief scientific and medical officer. "We are encouraged by the positive, preliminary data from the cumulative skin irritation and absorption studies, as well as earlier pre-clinical studies that show XMP.629's potent bactericidal activity and undetectable level of systemic absorption within various patient groups. We look forward to seeing more data from our controlled Phase II trial in mild to moderate acne patients, which should be available in August of 2004."
Cumulative Irritation Study Results
After receiving a XMP.629 gel (0.1%), vehicle gel and a positive control (0.3% sodium lauryl sulfate) under separate occlusive patches to their backs three times per week over a three-week period, 35 healthy adult patients did not experience any significant skin irritation in areas where the vehicle gel or XMP.629 gel were applied. The area where the positive control was applied showed mild irritation, as expected. Evaluations of skin reactions on the test sites were made on a six-point scale of 0 (no sign of irritation) to 4 (erythema with edema and blistering). Mean irritation scores were tabulated by site (test article) and evaluation day and were summed across days for each test article.
The cumulative irritation score for each test article was calculated by taking the total irritation score and dividing it by the highest theoretical score. The mean cumulative irritation score for the XMP.629 gel was calculated at 0.08. This score was comparable to the mean cumulative irritation score for the vehicle gel (0.07) and markedly lower than the mean cumulative irritation score for the positive control 0.3% sodium lauryl sulfate, 0.25 (p less than 0.001).
Absorption Study Results
Data from this single center, open-label absorption study show that the daily topical application of 4 grams of the XMP.629 gel in fifteen patients with moderate to very severe acne lacked measurable systemic absorption, was well tolerated, and demonstrated a reduction in baseline erythema, itching, and lesion count after 14 days of topical treatment. Cutaneous safety assessments illustrated that this treatment was not associated with any scaling, itching, burning and stinging, but reduced mild (n = 10) and moderate (n = 2) baseline erythema to zero at Day 14. Three patients reported four adverse events of which, one, mild dry skin, was considered related to the study drug. All adverse events were mild and reversible. There were also no clinically significant changes in laboratory tests, ECG, vital signs or physical exam findings.
Preliminary activity results show a 33% decrease from baseline in mean inflammatory lesion count, a 28% decrease in mean non-inflammatory lesion count and a 30% decrease in mean total lesion count at Day 15. In addition, 53% of patients had at least a one grade improvement on the Evaluator Global Severity Scale (a visual evaluation of acne severity based on a six-point scale) score in their face, 40% on their back, and 33% on their chest.
XOMA is currently conducting a randomized, double-blind, placebo-controlled, dose-ranging efficacy and safety study of 240 patients with mild-to-moderate acne. Preliminary results are expected to be released by the end of August of 2004. The company expects to make a decision as to the next development steps for the product, including potentially entering into Phase III trials before year end of 2004.
XOMA's two abstracts and posters, the Cumulative Skin Irritation Potential of XMP.629 and the Absorption of XMP.629, a New Antimicrobial Peptide in Subjects with Moderate to Very Severe Acne, can be found in a pdf format at either XOMA's website at www.xoma.com or the American Academy of Dermatology website at www.aad.org.
About XMP.629
XMP.629 is a synthetic peptide compound derived from bactericidal/permeability-increasing protein (BPI) -- a human host-defense protein that is part of the body's early lines of defense against invading microorganisms. The compound kills acne-causing bacteria.
In preclinical studies, XOMA scientists evaluated antibacterial activity of XMP.629 against P. acnes and other skin flora. They found that the compound, in a proprietary formulation buffer, showed bactericidal activity against P. acnes, including strains resistant to other antibiotics such as erythromycin or clindamycin.
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