Clinical Trials Roundup—Week of 7/5
Labopharm Completes Phase I Trial of Xopenex
Labopharm Inc. (Laval, PQ, Canada) has successfully completed a Phase I, 18-subject, single-dose study comparing three dose concentrations of Xopenex (levalbuterol HCI), in a solid controlled release dosage form using Contramid technology, to the marketed dose of Volmax and placebo. Xopenex is single isomer extended release levalbuterol (R-albuterol), whereas Volmax is an extended release racemic albuterol formulation containing a 50:50 mixture of levalbuterol and (S)-albuterol.
This study compared the pharmacokinetic profiles of single isomer levalbuterol delivered in a Contramid formulation, to that of Volmax. Results show that the Contramid formulation at an equivalent dose of the active (R)-isomer delivers a sustained dose with essentially comparable pharmacokinetics over a 12-hour period. The study also demonstrated that plasma concentrations of the inactive (S)-isomer substantially exceeded those of the active isomer when the racemic drug is dosed as the Volmax formulation.
For more information: Donald Buxton, President and CEO, Labopharm Inc., 1200 Chomedey Blvd., Suite 500, Laval, PQ, H7V 3Z3, Canada. Tel: 450-686-1017. Fax: 450-686-9141.
NeuroVir's G207 Deemed Safe in Phase I Trial
NeuroVir Therapeutics Inc. (San Diego) has released preliminary results of a Phase I clinical study of G207, a new anti-cancer product based on a tumor-killing herpes simplex virus (HSV). G207 is a genetically engineered HSV that has been designed to selectively infect and kill tumor cells while not invading and damaging normal brain tissue.
The Phase I study, which involved treatment of 21 patients with recurrent glioblastoma (a type of malignant brain tumor) by single and multiple stereotactic injections directly into their tumors, was designed to evaluate safety and preliminary tumor response. With respect to safety, G207 was well tolerated and there were no serious adverse events considered related to G207 therapy. And of the 17 patients for whom follow-up data are available, three have had stable disease at or beyond three months, one patient was stable at 5 months, and one patient was stable at 9 months.
For more information: NeuroVir Therapeutics Inc., #100-2386 East Mall, Vancouver, BC, V6T 1Z3, Canada. Tel: 604-822-0577. Fax: 604-822-0607.
CV Therapeutics Initiates Second Phase III Trial for Ranolazine
CV Therapeutics Inc. (Palo Alto, CA) has initiated its second pivotal Phase III clinical trial for ranolazine. The Carisa (combination assessment of ranolazine in stable angina) trial is a randomized, double-blind, placebo-controlled trial of ranolazine used in combination with other anti-anginal drugs, in approximately 450 patients. Ranolazine is being developed for the potential treatment of chronic stable angina.
The primary endpoint for this trial, duration of exercise on a treadmill, is identical to that used in Phase II clinical trials. In three prior Phase II clinical trials, over 500 patients received ranolazine, of which approximately two thirds of the patients received ranolazine in combination with other anti-anginal drugs. The Carisa trial, along with the pivotal Phase III Marisa (monotherapy assessment of ranolazine in stable angina) trial is expected to form the basis of the company's NDA submission to the FDA.
For more information: Louis G. Lange, President and CEO, CV Therapeutics Inc., 3172 Porter Dr., Palo Alto, CA 94304. Tel: 650-812-0585. Fax: 650-858-0390.
Axis Genetics Begins U.S. Clinical Trials of Oral Hepatitis B Vaccine
Following the success of the Axis Genetics' (Cambridge, UK) IND filing with the FDA, the Roswell Park Cancer Institute (RPCI; Buffalo, NY) and the Boyce Thompson Institute for Plant Research (BTI) at Cornell University (Ithaca, NY) have initiated U.S. clinical trials to test the safety and effectiveness of the world's first potential oral vaccine against the hepatitis B virus.
In this placebo-controlled, double-blind, Phase I study, healthcare workers who previously responded to a licensed, injectable vaccine will receive an oral booster dose. This dose will be delivered by a sample of genetically engineered potato that expresses the hepatitis B surface antigen.
For more information: Iain Cubitt, CEO, Axis Genetics, Babraham, Cambridge CB2 4AZ, UK. Tel: +44 1223-837611. Fax: +44 1223-837604.
Nastech's Intranasal Scopolamine Prevents Motion Sickness in Phase III Studies
Nastech Pharmaceutical Co. Inc. (Hauppauge, NY) has completed Phase III clinical studies of intranasal scopolamine, the company's new pharmaceutical prescription product for both the treatment and prevention of motion sickness. Intranasal scopolamine is expected to be a convenient, easy-to-use product that is designed to address several unmet needs in the treatment of motion sickness.
Data from the prevention studies among patients on short sea cruises showed that only 29% of patients receiving intranasal scopolamine experienced incidences of motion sickness compared to 69% of patients receiving the placebo. The duration of action was 6–8 hours. In treatment studies conducted under similar short sea cruise conditions, intranasal scopolamine was shown to alleviate symptoms of motion sickness in 82% of cases compared to 59% of those receiving a placebo. The onset of relief from some sufferers using scopolamine was under 30 minutes.
For more information: Vincent D. Romeo, President and CEO, Nastech Pharmaceutical Co. Inc., 45 Davids Dr., Hauppauge, NY 11788. Tel: 516-273-0101. Fax: 516-273-0252.