Clinical Trials Roundup—Week of 5/10

Angiotech Completes Trial of Micellar Paclitaxel for Secondary Progressive MS
Angiotech Pharmaceuticals Inc. (Vancouver, BC) has released initial treatment results from its Phase I/II clinical study of micellar paclitaxel for the treatment of secondary progressive multiple sclerosis—a condition that currently has no approved treatment. A significant percentage of patients in the trial showed favorable trends in overall disability and function, quality of life, and changes in the amount of brain tissue scarring as demonstrated by MRI.

Although the study's primary objective of demonstrating safety and tolerability of the drug was met, the finding that a significant proportion of the patients appeared to benefit from the therapy has led the company to accelerate its clinical development. As a result, Angiotech also plans to initiate a later stage clinical study by the end of the year.

For more information: Angiotech Pharmaceuticals Inc., 6660 NW Marine Dr., Vancouver, BC. V6T 1Z4, Canada. Tel: 604-221-7676. Fax: 604-221-2330.

Ampligen Ineffective in Treating HIV
Value Management & Research AG (VMR), a Germany-based asset-management firm, recently released a report on Hemispherx Biopharma Inc. (Philadelphia), stating that AIDS researchers have "only very recently" reviewed certain Ampligen studies undertaken in the early 1990s that found the drug to be effective as an immune modulator. In fact, Ampligen has been tested and has never been proved effective against HIV in clinical studies.

Sherrie Shade—a regulatory review officer in the division of Drug Marketing, Advertising and Communications for the FDA—informed William Carter, CEO of Hemispherx, that "Hemispherx should immediately discontinue the dissemination of materials that make claims of safety or efficacy for Ampligen." It is unlawful for Hemispherx to claim, or participate in the dissemination of claims, that Ampligen is safe or effective as either an AIDS treatment or as an immune modulator.

For more information: Asensio and Company Inc., 767 Third Avenue, New York, NY 10017. Tel: 212-702-8805.

Cerus Completes Phase 1a Trial, Initiates Second Trial of S-303
Cerus Corp. (Concord, CA) has initiated a second clinical trial of S-303—its proprietary system to inactivate viruses, bacteria, and other pathogens in red blood cells intended for transfusion—to evaluate the safety, tolerability, and viability of red blood cells treated with the pathogen inactivation system. Cerus also announced that its Phase 1a clinical trial of its red blood cell pathogen inactivation system showed that the circulation of both S-303-treated and untreated red blood cells 24 hours after transfusion exceeded the established standard for red blood cell recovery.

The Cerus red blood cell pathogen inactivation system has been developed to target and inactivate blood-borne pathogens while leaving the therapeutic properties of red blood cells intact.

For more information: Stephen Isaacs, President and CEO, Cerus Corp., 2525 Stanwell Dr., Ste. 300, Concord, CA 94520. Tel: 925-603-9071. Fax: 925-603-9099.

Onyx to Study ONYX-015 in Patients with Barrett's Esophageal Metaplasia
Onyx Pharmaceuticals Inc. (Richmond, CA) has expanded human clinical testing of its lead anticancer agent, ONYX-015, to include a Phase I study in patients with Barrett's esophageal metaplasia, a pre-cursor to esophageal cancer involving localized lesions in the esophagus. The study is designed to evaluate the safety, maximum tolerated dose, and biological activity of ONYX-015 when administered via intralumenal lavage.

ONYX-015 is a genetically engineered adenovirus that, in prior preclinical and clinical studies, has been shown to replicate in and kill tumor cells deficient in p53 tumor suppressor gene activity. Mutations in p53 are the most common type of genetic abnormality in cancer, occurring in more that 50% of human cancer cases and more than 90% of cases of high-grade Barrett's esophageal metaplasia.

For more information: Hollings Renton, President and CEO, Onyx Pharmaceuticals Inc., 3031 Research Dr., Bldg. A, Richmond, CA 94806. Tel: 510-222-9700. Fax: 510-222-9758.

Phase II Study of Ontak for Non-Hodgkin's Lymphoma Initiated; Second Trial Planned
The Eastern Cooperative Oncology Group (ECOG) of the National Cancer Institute has initiated a Phase II study of Ligand Pharmaceuticals Inc.'s (San Diego) Ontak (denileukin diftitox, DAB389 IL2) in patients with non-Hodgkin's lymphoma (NHL). The primary purpose of the multi-center study is to determine the objective response rate to Ontak administered to patients with certain types of low- and intermediate-grade NHL who have been previously treated with at least one systemic anti-cancer therapy.

Ligand is also developing a second multi-center trial protocol for Ontak in patients with low-grade NHL who have been previously treated with at least one chemotherapy regimen and at least one monoclonal antibody therapy. This second trial will evaluate objective response rates at a dose of 9 mcg/kg per day for five consecutive days and compare four cycles of therapy versus eight cycles of therapy. This trial is expected to begin later this year.

For more information: Ligand Pharmaceuticals Inc., 10275 Science Center Dr., San Diego, CA 92121-1117. Tel: 619-550-7500. Fax: 619-550-7506.