Clinical Trials Roundup—Week of 7/12
Tanox Begins Phase I/II Trial of Hu-901 for Peanut Allergy
Tanox Inc. (Houston) has initiated a Phase I/II clinical trial in severe peanut allergy with Hu-901, the company's anti-IgE monoclonal antibody. Tanox is independently evaluating Hu-901 for the treatment of IgE-mediated allergic diseases outside the current clinical focus of rhuMab-E25 anti-IgE, which is being jointly developed in collaboration with Genentech and Novartis.
The Phase I/II trial will take place under an Investigational New Drug Application filed by Tanox with the FDA. Volunteers for the study will have a history of severe allergic reactions to peanuts. During the study, individuals who have allergic reactions to peanut will be treated with Hu-901 and will then be tested to see if their sensitivity to peanut has been reduced and they can eat more peanuts before a reaction occurs.
For more information: Nancy Chang, President, Tanox Inc., 10301 Stella Link, Houston, TX 77025. Tel: 713-664-2288. Fax: 713-664-8914.
Insmed Completes Phase II Trial of INS-1 for Type 2 Diabetes
Insmed Pharmaceuticals Inc. (Richmond, VA) has completed a Phase II clinical study in type 2 diabetes for its lead compound, INS-1. Treatment with INS-1 resulted in an improvement in parameters for glycemic control and lipid profile, and did not induce significant body weight gain. In subjects considered to be most insulin-resistant, the drug had a more pronounced effect, significantly reducing plasma triglyceride, cholesterol, and LDL cholesterol concentrations and improving glycemic excursions following an oral glucose load.
Type 2 diabetes occurs when the body does not make enough, or properly use, insulin—a phenomenon known as insulin resistance. Scientists at Insmed believe that a defect in the use of an "insulin mediator"—a key molecule involved in the metabolism of sugar in the blood stream—is responsible for insulin resistance. Insmed's INS-1 appears to boost the formation of the mediator, improving insulin sensitivity and, therefore, glucose control.
For more information: Geoffrey Allan, President and CEO, Insmed Pharmaceuticals Inc., Virginia Biotechnology Research Park, 800 E. Leigh St., Richmond, VA 23219. Tel: 804-828-6893. Fax: 804-828-6894.
ViroPharma's Pleconaril Speeds Recovery from VRI in Phase II Trial
ViroPharma Inc. (Exton, PA) has released results from its Phase II program with pleconaril to treat patients with viral respiratory infection (VRI), a severe form of the common cold. Trial results indicated that pleconaril-treated patients experienced a clinically and statistically significant reduction in time to complete resolution of all disease symptoms, as well as a reduction in the patient-reported time to returning to feeling normal, as measured by a global assessment score.
Pleconaril is a novel orally acting small molecule with broad anti-picornavirus activity that is being developed by ViroPharma for treatment of certain picornavirus diseases. Pleconaril works by specifically inhibiting the function of the picornavirus capsid, the protective protein shell of the virus that is essential for virus infectivity and transmission. The drug integrates within the viral capsid at a specific site that is common to the majority of all rhinoviruses and enteroviruses, disrupting several stages of the virus infection cycle.
For more information: Claude Nash, CEO, ViroPharma Inc., 405 Eagleview Blvd., Exton, PA 19341. Tel: 610-458-7300. Fax: 610-458-7380.
Vertex's Timcodar Dimesylate Improves Nerve Function in Animal Models
According to preclinical studies, Vertex Pharmaceuticals Inc.'s (Cambridge, MA) timcodar dimesylate (VX-853) was reported to improve nerve function and provide neural protection in animal models of diabetic neuropathy, toxin-induced neuropathy, and Parkinson's disease. Timcodar dimesylate, an orally bioavailable neurophilin ligand, is currently being evaluated in a Phase II clinical trial for reversal of neural dysfunction in patients with diabetic neuropathy.
Neurophilin ligands are small molecules that have the potential to promote neurite outgrowth and accelerate recovery following nerve injury. They may play a future role in the treatment of a variety of acute and chronic neurological conditions.
For more information: Vicki Sato, Chief Scientific Officer, Vertex Pharmaceuticals Inc., 130 Waverly St., Cambridge, MA 02139-4242. Tel: 617-577-6000. Fax: 617-577-6680.
Novartis Initiates Phase III Trials of SDZ ASM 981 for Atopic Dermatitis
Novartis Pharmaceuticals Corp. (Summit, NJ) has started Phase III clinical trials for SDZ ASM 981, a prescription non-steroid cream for the treatment of atopic dermatitis. The studies will examine the long-term safety and efficacy of SDZ ASM 981 in more than 1000 patients, adults and children, in the U.S. and Europe.
SDZ ASM 981 is a selective inhibitor of inflammatory cytokines and the first ascomycin macrolactam derivative under development for the treatment of inflammatory skin diseases.
For more information: Geoffrey M. Cook , Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936. Tel: 973-781-5486. Fax: 973-781-7828.
OxSODrol Reduces Incidence of Asthma and Neurodevelopmental Defecits in Premature Infants
Bio-Technology General Corp. (Iselin, NJ) has analyzed data from of it's Phase IIIevaluations of 152 premature infants, undertaken at 6 and 12 months of age, who had participated in a clinical efficacy study of OxSODrol (SOD), BTG's genetically engineered superoxide dismutase product.
At one year, a positive trend emerged for the SOD-treated babies with respect to a reduction in the incidence of both asthma and neurodevelopmental deficits, suggesting a potential benefit from treatment of premature neonates with OxSODrol. This trend was more marked in those infants who weighed less than 1,000 grams at birth. While the analysis was based on a sample too small to establish statistical significance, the trend is sufficiently encouraging to warrant further clinical investigation of the product.
For more information: Sim Fass, CEO, Bio-Technology General Corp., 70 Wood Ave. South, Iselin, NJ 08830. Tel: 732-632-8800. Fax: 732-632-8844.
IntraBiotics Completes Successful Phase II Trial of Orally Administered Ramoplanin
IntraBiotics Pharmaceuticals Inc. (Mountain View, CA) has completed its Phase II clinical trial of orally administered ramoplanin for the suppression of vancomycin-resistant enterococci (VRE), which are carried in the intestinal tract of affected persons.
An independent Data Safety Monitoring Board evaluated the results of the trial and determined that sufficient evidence of effectiveness and safety was apparent. Administration of ramoplanin suppressed VRE below detectable levels from nearly all of the patients who carried VRE prior to the study. The DSMB recommended early termination of Phase II because of the effectiveness observed and to make preparations for Phase III clinical trial.
For more information: Henry J. Fuchs, VP of Clinical Affairs, IntraBiotics Pharmaceuticals Inc., 1245 Terra Bella Ave., Mountain View, CA 94043. Tel: 650-526-6800.
NeoRx's Skeletal Targeted Radiotherapy Deemed Safe in Phase I/II Trial
NeoRx Corp. (Seattle) reported that its Skeletal Targeted Radiotherapy (STR) product produced an acceptable safety profile in 28 patients who had been monitored for safety in a Phase I/II trial, and that 9 of 17 of these patients had achieved complete regression of their tumors. The remaining 11 patients have not yet been fully evaluated for response and further dose escalation is ongoing.
STR employs a molecule that targets the bone as a means of administering radiation to the bone and bone marrow. The molecule tightly binds Holmium-166, a beta emitting radionuclide. STR either targets the bone or rapidly exits the body. To date, investigators have not seen any evidence of toxicity to other organs resulting from this radiation therapy.
For more information: Paul Abrams, CEO, NeoRx Corp., 410 W. Harrison St., Seattle, WA 98119-4007. Tel: 206-281-7001. Fax: 206-284-7112.
Ribozyme, Chiron Complete Phase Ia, Ib Trials of Angiozyme Compound
Ribozyme Pharmaceuticals Inc. (RPI; Boulder, CO) and Chiron Corp. (Emeryville, CA) have successfully completed Phase Ia and Ib human clinical trials of the anti-angiogenesis cancer compound, Angiozyme. The Phase Ia trial demonstrated excellent tolerability of low single doses of Angiozyme to healthy volunteers. The subsequent Phase Ib trial, performed with cancer patients, extended to higher single doses of Angiozyme up to 300 mg/m2 to help define appropriate dosing for future Phase II and III trials. No clinically significant drug-related side effects were observed at any dose in the Phase Ia and Ib studies.
Angiozyme specifically inhibits angiogenesis and resulting cancer tumor growth and metastases by inhibiting production of the Vascular Endothelial Growth Factor receptor (VEGF-r), a key component that regulates the growth of new blood vessels that nourish malignant tumors. By minimizing the new blood supply to tumors, Angiozyme was shown in preclinical studies to halt tumor growth and prevent the growth and spread of metastases.
For more information: Ralph E. Christoffersen, CEO and President, Ribozyme Pharmaceuticals Inc., 2950 Wilderness Place, Boulder, CO 80301. Tel: 303-449-6500. Fax: 303-449-6995.
Cubist Files to Initiate Phase II Trial of Intravenous Daptomycin in Europe, Israel
Cubist Pharmaceuticals Inc. (Cambridge, MA) has filed regulatory submissions for the initiation of a pivotal Phase III clinical trial for intravenous daptomycin, the company's novel antibiotic to combat serious and life-threatening infections, in six European Union countries and Israel. In the trial, the safety and efficacy of daptomycin will be evaluated in patients with complicated skin and soft tissue infections due to gram-positive bacteria.
The advantages of daptomycin include its rapidly bactericidal activity and effectiveness against all gram-positive bacterial strains, including drug resistant strains. Daptomycin has a favorable side effect profile and will be administered as a once-a-day therapy.
For more information: Scott M. Rocklage, President and CEO, Cubist Pharmaceuticals Inc., 24 Emily St., Cambridge, MA 02139. Tel: 617-576-1999. Fax: 617-576-0232.
Salix Gives Update on Phase III Trial of Rifaximin for BID
Salix Pharmaceuticals (Palo Alto, CA) updated the status of its phase III clinical trial to investigate rifaximin for the treatment of bacterial infectious diarrhea (BID). Rifaximin is a new, broad-spectrum antibiotic. The drug is chemically structured to be active in the gastrointestinal tract while remaining minimally absorbed.
The trial is a multicenter, randomized, double-blind study comparing the safety and efficacy of rifaximin 600 mg/day and 1200 mg/day to placebo for three days, in travelers affected by BID. Patient enrollment for the study began in May and to date more than 70 patients have been treated, mainly in Antigua-Guatemala and Guadalajara, Mexico. The study is expected to be completed by early next year.
For more information: Lise Riopel, VP of Clinical Affairs, Salix Pharmaceuticals Ltd., 3600 W. Bayshore Rd., Suite 205, Palo Alto, CA 94303. Tel: 650-856-1550. Fax: 650-856-1555.