By Brady Huggett
Genelabs Technologies Inc. gave three presentations at the 64th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia based on three Phase III trials on GL701, a drug for which the company is seeking approval to treat lupus.
"We submitted the application on Sept. 26," said James Smith, president and CEO of Genelabs. "And last week we received notification that it was designated for priority review. The guideline is to review it in six months from the time we submitted it, so by the end of March we should hear something."
The rheumatology conference gave Genelabs, of Redwood City, Calif., a stage to present for the first time to a large audience results of three Phase III trials, Smith said. One presentation, focused on a Phase III trial conducted in Taiwan by Genelabs Biotechnology Co. Ltd., a Genelabs licensee, showed that the number of patients suffering debilitating flares or exacerbation of lupus significantly declined with the use of GL701. The study compared GL701 to placebo in 119 Taiwanese women with lupus.
A second presentation detailed GL701 and prednisone, showing that Aslera (GL701) improves bone mineral density and prevents bone mineral density loss in female patients with lupus when given prednisone.
The third presentation showed Aslera significantly improves disease activity and symptoms of patients with lupus.
Smith said an FDA approval for GL701 would benefit both his company and lupus patients worldwide.
"[An approval] would provide for the first new drug specifically for lupus in the last 40 years," Smith said. "Commercially, the market for lupus is quite substantial."
Genelabs' stock (NASDAQ:GNLB) closed down 34 cents Tuesday at $5.218.
In other news from the meeting:
¿ Centocor Inc., of Malvern, Pa., a subsidiary of Johnson & Johnson, presented two-year data from a Phase III pivotal study evaluating the impact of Remicade in combination with methotrexate on structural damage in people with rheumatoid arthritis. The findings suggest that the benefits of the combined therapy can be sustained beyond one year and Remicade generally was well tolerated. Remicade is approved in combination with methotrexate for the reduction of signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate. In July, the Arthritis Advisory Committee to the FDA recommended approval of the therapy for reduction of structural damage in this patient population.
¿ La Jolla Pharmaceutical Co., of San Diego, said its experimental drug LJP 394 prevented renal flare completely in all 11 patients with high-affinity antibodies to the drug. The 11 were among 27 patients with poor renal function in a Phase II/III. More than 200 patients were enrolled in that study and treated for up to 18 months. Three presentations related to drug were given: "Effect of LJP 394 on Patients with Greatest Impairment of Renal Function at Baseline in the 90-05 Trial"; "SLE Trial Shows Fewer Flares in LJP 394-Treated Patients with High-Affinity Antibodies to JLP 394: 90-05 Trial Results"; and "Affinity of Antibodies for LJP 394 Influences Pharmacodynamic Response to LJP 394 in SLE Patients with Positive dsDNA Antibody Titers."
¿ Immunex Corp., of Seattle, contributed $1 million to the American College of Rheumatology's Pediatric Rheumatology Visiting Professorship Program. The program helps address the lack of pediatric rheumatologists to help treat more than 100,000 children and teen-agers struck with juvenile rheumatoid arthritis and other rheumatic diseases.
¿ Scios Inc., of Sunnyvale, Calif., presented preclinical data on SCIO-469, showing it inhibits p38, a modulator of pro-inflammatory factors including tumor necrosis factor-alpha, IL-1 and cyclooxygenase-2, which are known to contribute to both symptoms and disease progression in patients with rheumatoid arthritis. Scios said it intends to start a Phase I, double-blind, placebo-controlled, dose-ranging study evaluating the safety and tolerability of SCIO-469. The trial in England will enroll approximately 30 healthy volunteers and evaluate six different oral doses of SCIO-469 for safety and tolerability, as well as assessing pharmacokinetic differences in female and elderly populations. Results should be available during the first quarter of 2001.