Clinical Trials Roundup—Week of 1/4
Cell Pathways Files IND Application To Begin Safety Study Of CP461
Cell Pathways, Inc. has filed an Investigational New Drug application to begin a Phase I human clinical safety study of CP461. Following an initial single-dose safety study in healthy volunteers, the company plans to conduct a dose-ranging Phase I/II study of CP461 as a potential treatment for cancer.
CP461 is a member of a new class of therapeutic agents called selective apoptotic anti-neoplastic drugs (SAANDs). The investigational drug selectively triggers apoptosis (programmed cell death) in abnormal cells by inhibiting an enzyme (a novel cyclic-GMP phosphodiesterase or cGMP-PDE) that can interfere with the message signaling those cells to die.
For more information: Dr. Rifat Pamukcu, Cell Pathways, Inc., telephone: 215-706-3800.
PPT Requests FDA Approval To Commence Urethral Bulking Agent Testing
Protein Polymer Technologies, Inc. has requested authorization from the U.S. Food and Drug Administration to begin human clinical testing of its urethral bulking agent for treatment of female stress urinary incontinence. Pending FDA approval of the Company's application, the Company plans to initiate clinical trials in the second quarter of 1999.
For more information: Protein Polymer Technologies, Inc., 10655 Sorrento Valley Road, San Diego, CA 92121. Telephone: 619-558-6064.
First Patients Enrolled In Phase I Study Of Bisphosphonate Ester Derivative
ILEX Oncology, Inc. and Symphar S.A. of Geneva, Switzerland, co-developers of SR-45023A, have enrolled the first patients in a Phase I clinical study at the University of Arizona. SR-45023A is an orally active bisphosphonate ester derivative that binds to a newly identified nuclear receptor (FXR), selectively inducing cell death (apoptosis) in malignant cells, without adversely affecting normal cells.
For more information: Deborah Sibley, ILEX Oncology, Inc., telephone: 210-949-8287.
Cubist Files To Begin Phase III Daptomycin Trials
Cubist Pharmaceuticals, Inc. has filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin Phase III clinical trials for intravenous daptomycin, the company's novel antibiotic to combat life-threatening infections.
Daptomycin is a novel lipopeptide antibiotic derived from Streptomyces roseosporus. The drug appears to bind to the membranes of all gram-positive bacteria, disrupting bacterial membrane function and causing cell death by inhibition of peptidoglycan, DNA, RNA and protein biosynthesis.
For more information: Cubist Pharmaceuticals, 24 Emily Street, Cambridge, MA 02139, USA. Telephone: 617-576-1999. Fax: 617-576-0271.
Visudyne Preserves Vision In Wet AMD Patients
QLT PhotoTherapeutics, Inc. and CIBA Vision Corp. have announced that Visudyne (verteporfin) therapy has been shown to preserve vision in a significant number of patients with the "wet" form of age-related macular degeneration. The findings are based on an initial 12-month analysis of 24-month pivotal Phase III studies using Visudyne. The treatment is part of an emerging new platform technology known as photodynamic therapy, being co-developed by QLT and CIBA Vision.
For more information: Elayne Wandler or Tamara Hicks, QLT PhotoTherapeutics, Inc., 520 West 6th Ave., Vancouver, BC, Canada, V5Z 4H5. Telephone: 1-800-663-5486 or 604-872-7881. Fax: 604-873-0816.
Axys Initiates Trial Of Psoriasis Treatment
Axys Pharmaceuticals, Inc. has initiated a Phase I, double blind, placebo-controlled clinical trial designed to evaluate the safety and absorption of a cream formulation of APC 2059 in 20 healthy subjects. The formulation is intended for the treatment of psoriasis.
APC 2059 is a proprietary Axys compound designed to inhibit the enzyme tryptase, which has been demonstrated to be involved in psoriasis and other inflammatory diseases.
For more information: John Walker or David Gennarelli, Axys Pharmaceuticals, Inc., telephone: 650-829-1000.
Cell Genesys Reports Effective Gene Therapy For Hemophilia In Animal Models
Cell Genesys, Inc. has demonstrated effective gene therapy in both small and large animal models for hemophilia using an adeno-associated viral (AAV) gene delivery system. Following a single injection of the factor IX gene (a gene deficient in certain hemophiliacs) into the liver, stable production of the factor IX protein was observed for seventeen months in mice and for eight months in large animals, which were the last measurement dates in the studies.
For more information: Cell Genesys, Inc., 322 Lakeside Drive, Foster City, CA 94404, USA. Telephone: 650-425-4400. Fax: 650-425-4457.
SIBIA Neurosciences Initiates Second Phase II Study Of Nicotinic Agonist
SIBIA Neurosciences, Inc. has initiated a second Phase II study of their subtype-selective nicotinic agonist, SIB-1508Y, for Parkinson's disease. This is a double-blind, randomized, placebo controlled, crossover study measuring safety, tolerability and efficacy of SIB-1508Y in mid-to-late-stage Parkinson's patients who will also receive half their usual dose of L-DOPA.
In SIBIA's initial Phase 2 study, which is still ongoing, SIB-1508Y is being tested as a monotherapy in early stage Parkinson's patients who have never received other drug therapy for their illness. Both Phase 2 studies are aimed at assessing the ability of SIB-1508Y to treat the cognitive as well as motor deficits of Parkinson's patients.
For more information: SIBIA Neurosciences, Inc., 505 Coast Boulevard South, Suite 300, La Jolla, CA 92037-4641, USA. Telephone: 619-452-5892. Fax: 619-459-1609.
ViroPharma Announces Results Of Pleconaril Trial
ViroPharma, Inc. has announced the results from its preliminary evaluation of the second of four studies of pleconaril for the treatment of viral meningitis. The trial was a double-blind, placebo-controlled study of 130 adult patients with viral meningitis who were administered either a 200 mg dose of pleconaril or a placebo three times per day.
Patients treated with the pleconaril dose experienced both a statistically significant and clinically beneficial reduction in duration of headache, ViroPharma reports. Pleconaril is an orally bioavailable small molecule with broad anti-picornavirus activity.
For more information: ViroPharma, Inc., 405 Eagleview Boulevard, Exton, PA 19341. Fax: (610) 458-7380.
OXIS Compound Well Absorbed In Patients With Ulcerative Colitis
OXIS Therapeutics, Inc. has reported the initial results from a Phase IIa clinical trial of its lead compound, BXT-51072, in patients with mild to moderate ulcerative colitis (UC). UC is a form of inflammatory bowel disease (IBD) that affects approximately 250,000 patients in the U.S. alone. BXT-51072 is a small molecule that mimics the action of the natural antioxidant enzyme, glutathione peroxidase, thereby blocking the activity of free radicals, the toxic molecules believed to be involved in the damage seen in IBD and other inflammatory diseases.
The initial group of nine patients in the trial with mild to moderate UC who had failed to respond to standard first-line therapy received BXT-51072 at a dose of 40 mg orally three times a day for 28 days. Results demonstrated that the drug, when administered orally, was well absorbed.
For more information: Dr. Timothy C. Rodell, OXIS Therapeutics, Inc., telephone: 503-247-2373.
SIBIA Neurosciences Completes Trial Of Alzheimer Therapy
SIBIA Neurosciences, Inc. has announced the successful completion of a seven-day multiple dose Phase 1 study of SIB-1553A, its subtype-selective nicotinic agonist, and the initiation of a Phase II study with the compound in Alzheimer's disease patients.
In the Phase I multiple dose study, SIB-1553A was well tolerated, no significant adverse events were observed and it exhibited linear pharmacokinetics. As in the previous Phase I single-dose study, central nervous system activity was demonstrable by quantitative EEG. In addition, SIB-1553A appeared to enhance performance in behavioral tests of attention and cognition.
For more information: SIBIA Neurosciences, Inc., 505 Coast Boulevard South, Suite 300, La Jolla, CA 92037-4641, USA. Telephone: 619-452-5892. Fax: 619-459-1609.
Velogene Rapid MRSA Test Identifies Samples In Clinical Trial
The preliminary results of a clinical trial into ID Biomedical Corp.'s Velogene rapid culture confirmation test for methicillin resistant Staphylococcus aureus (MRSA) has identified 100% of 308 samples tested.
The Velogene Rapid MRSA Test detects the mecA gene responsible for antibiotic resistance. It is based on ID Biomedical's proprietary gene identification technology known as Cycling Probe Technology (CPT). MRSA and regular Staphylococcus aureus are common causes of hospital acquired infections, including wound and post-surgical infections as well as life-threatening bloodstream infections.
For more information: ID Biomedical Corp., 8855 Northbrook Court, Burnaby, BC, V5J 5J1. Telephone: 604-431-9314 or 604-419-9300. Fax: 604-431-9378.
Aronex Initiates Study Of Atragen And Interferon Alpha Combination
Aronex Pharmaceuticals, Inc. has initiated a Phase I/II study utilizing the combination of Atragen and interferon alpha in patients with advanced renal cell carcinoma. Atragen is a proprietary injectable formulation of all-trans retinoic acid (Atra or tretinoin) currently in clinical trials for the treatment of hematologic malignancies and solid tumors, including acute promyelocytic leukemia, non-Hodgkin's lymphoma and prostate cancer.
For more information: Aronex Pharmaceuticals, Inc., 8707 Technology Forest Place, The Woodlands, TX 77381-1191, USA. Telephone: 281-367-1666. Fax: 281-367-1676.
TOBI Brings Benefits To Cystic Fibrosis Patients In Studies
In two double-blind, placebo-controlled studies, chronic intermittent aerosolized antibiotic therapy with TOBI (tobramycin solution for inhalation) has demonstrated significant benefits in treating people with cystic fibrosis. TOBI was developed by PathoGenesis Corp. and approved for U.S. sale in Dec. 1997.
For more information: PathoGenesis Corp., 201 Elliott Avenue West, Seattle, WA 98119, USA. Telephone: 206-467-8100. Fax: 206-270-3313.