Clinical Trials Roundup—Week of 2/8

NuChem anti-Cancer Compounds Prove Efficacy

NuChem Pharmaceuticals Inc. has reported additional positive preclinical efficacy data on four novel anti-cancer compounds, NC407, NC381, NC383 and NC384. The in vivo study involving a murine lung cancer prevention model found that, relative to controls, the test compounds showed significant inhibition of squamous cell carcinoma tumors after daily oral administrations from three days to 5 weeks. In addition, no apparent toxic effect due to the treatment regimen was noted in the animals.

For more information: Paul W. Truscott, Jr., Lorus Therapeutics Inc., Telephone: 416-724-1509, ext. 251. Fax: 416-724-1167.

Prostate Cancer Study Cleared By FDA

Thomas Jefferson University (TJU; Philadelphia, PA), CEL-SCI Corp. and Drs. Michael Mastrangelo and Leonard Gomella of TJU Hospital have been cleared by the FDA to start a second prostate cancer study. The study will test Multikine, an immune boosting product by CEL-SCI, in escalating doses as a pre-treatment before prostatectomy (surgical removal of the prostate) in up to 20 previously untreated, advanced prostate cancer patients.

For more information: CEL-SCI Corp., 8229 Boone Boulevard, Suite 802, Vienna, VA 22182, USA. Telephone: 703-506-9460. Fax: 703-506-9471.

Cerus Announces Framework Of Platelet Pathogen Inactivation Trial

Cerus Corp., in consultation with the U.S. FDA, has determined the preliminary framework governing the company's Phase III clinical trial protocol for its platelet pathogen inactivation system. Based on recent discussions with the FDA, Cerus believes that the multiple site trial will be a randomized, controlled study designed to evaluate the ability of platelets treated with the company's pathogen inactivation system to control clinical bleeding.

The Cerus platelet system is based on the company's proprietary light-activated psoralen compound, S-59. This compound has been developed to target and inactivate blood-borne pathogens, such as hepatitis B and C, while leaving the therapeutic properties of platelets intact.

For more information: Cerus Corp., 2525 Stanwell Drive, Suite 300, Concord, CA 94520, USA. Telephone: 510-603-9071.

HGSI Launches Phase II Study Of KGF-2

Human Genome Sciences Inc. has initiated Phase II human clinical studies of its genomics-derived therapeutic protein drug, Keratinocyte Growth Factor-2 (KGF-2). The studies are designed to evaluate its safety and effectiveness as a topical wound healing treatment for venous ulcers. HGSI also plans to conduct additional Phase II clinical studies for other topical indications for this novel therapeutic protein product.

KGF-2 is a newly discovered human protein that HGSI scientists believe is always present in humans, and is activated only when there is an epithelial tissue wound. It may work by attracting fibroblasts, collagen and connective tissues to the site of the wound to heal it through the creation of new tissue. In skin, KGF-2 causes the creation of new dermal and epidermal tissue, healing full-thickness wounds in a short period of time with little scarring.

For more information: HGSI, 9410 Key West Avenue, Rockville, MD 20850-3338, USA. Telephone: 301-309-8504. Fax: 301-309-8512.

ProScript Initiates Trial Of Proteasome Inhibitor

ProScript Inc. has initiated a second Phase I clinical trial of its proteasome inhibitor PS-341, a novel cancer therapy that targets a key protein degradation pathway in cells. PS-341 is a potent, small molecule inhibitor of the ubiquitin-proteasome pathway that regulates many important cellular proteins through distinct mechanisms. PS-341 has been shown to inhibit cell growth signaling pathways, induce apoptosis, and inhibit the expression of cellular adhesion molecules in vitro.

For more information: David Lubner, ProScript Inc., telephone: 617-374-1470.

CV Therapeutics Reports CVT-510/Diltiazem Comparison Results

CV Therapeutics Inc. has published the results of a pre-clinical study comparing CVT-510, the Company's potent and selective A1 adenosine receptor agonist, with diltiazem. The paper, entitled "A comparison of an A1 adenosine receptor agonist (CVT-510) with diltiazem for slowing of AV nodal conduction in guinea-pig," appeared in the January 1999 issue of the British Journal of Pharmacology.

The study demonstrated that while both CVT-510 and diltiazem slowed AV nodal conduction, only CVT-510 maintained left ventricular contractility (pumping function of the heart) and arterial blood pressure—diltiazem caused a significant reduction in both measures of heart function in the guinea-pig. Slowing AV nodal conduction is an important step in slowing ventricular rate during atrial arrhythmias, and CVT-510 may therefore be a potential treatment for these common problems in humans.

For more information: CV Therapeutics Inc., 3172 Porter Drive, Palo Alto, CA 94304, USA. Telephone: 650-812-0585. Fax: 650-858-0390.

Axys Initiates Psoriasis And IBD Treatment Studies

Axys Pharmaceuticals Inc. has initiated Phase Ib studies of APC-2059 in two indications: as a topical cream formulation for the treatment of psoriasis, and as an injectable formulation for the treatment of acute inflammatory bowel disease (IBD). The company has successfully completed Phase Ia studies of APC 2059 for both psoriasis and IBD.

APC 2059 is a proprietary Axys compound and a member of a class of compounds designed to inhibit tryptase, an enzyme found in mast cells which has been demonstrated to be involved in inflammatory diseases.

For more information: John Walker, CEO, Axys Pharmaceuticals Inc., telephone: 650-829-1000.

Cellegy Begins Trial Of Hypogonadism Treatment

Cellegy Pharmaceuticals Inc. has commenced clinical trials using its transdermal testosterone gel for the treatment of male hypogonadism, a disorder frequently characterized by diminished libido and reduced muscle growth and strength.

For more information: Cellegy Pharmaceuticals Inc., 1065 E. Hillside Blvd., Suite 418, Foster City, CA 94404, USA. Telephone: 650-524-1600. Fax: 650-524-1616.