Clinical Trials Roundup -- Week of 8/23

BioCryst Receives Preliminary Results from RWJ-270201 Trial
BioCryst Pharmaceuticals Inc. (Birmingham, AL) has gathered preliminary results from a Phase II clinical study of RWJ-270201, a neuraminidase inhibitor, conducted by the R.W. Johnson Pharmaceutical Research Institute (PRI).

PRI conducted a Phase II placebo-controlled randomized study of healthy volunteers infected with a susceptible strain of Influenza A. The primary efficacy endpoint was the reduction in viral titers in infected subjects. Preliminary results showed a statistically significant result for the primary endpoint and evaluation of safety showed that the drug was well-tolerated at all dosage levels.

For more information: Charles E. Bugg, CEO, BioCryst Pharmaceuticals Inc., 2190 Parkway Lake Dr., Ste. B, Birmingham, AL 35244. Tel: 205-444-4600. Fax: 205-444-4640.

AVANT Conducting Phase I Study of Adjumer-Formulated Vaccine
AVANT Immunotherapeutics Inc. (Needham, MA) is working with Pasteur Merieux Connaught to evaluate the safety and immunogenicity of an Adjumer-formulated respiratory syncytial virus vaccine in a Phase I clinical study. Preliminary results of the study are encouraging, which supports further clinical development. Adjumer is AVANT's proprietary delivery system for injectable vaccines.

For more information: Una S. Ryan, President and CEO, AVANT Immunotherapeutics Inc., 119 Fourth Ave., Needham, MA 02194-2725. Tel: 781-433-0771. Fax: 781-433-0262.

Majority of Patients Stay on Ditropan XL Following Study
A majority of patients receiving once-a-day Ditropan XL, an extended-release formulation of oxybutynin for the treatment of overactive bladder, remained on therapy for a period of six months or more, according to interim results of a community-use study. Ditropan XL, developed by ALZA Corp. (Palo Alto, CA), is the only once-a-day treatment for overactive bladder in the U.S.

In the study, 62% of patients continued to take Ditropan XL for a period of six months or more. Of the patients who discontinued therapy, the majority did so within the first month or two of treatment.

For more information: ALZA Corp., 950 Page Mill Rd., Palo Alto, CA 94303-0802. Tel: 650-494-5000. Fax: 650-494-5151.

60% of Asthmatics Suffer from Medication Side Effects, Study Says
A new study indicates that more than 60% of asthma patients suffer from medication side effects. The study, conducted among the membership of the Allergy and Asthma Network-Mothers of Asthmatics Inc. (Fairfax, VA), reveals that up to one-third of adults and almost one-quarter of pediatric patient caregivers reporting side effects had skipped doses or taken less medicine than prescribed in an attempt to reduce medication side effects and improve quality of life.

The 1810-patient study also documented that the groups more likely to have emergency room visits, unscheduled doctor visits, or be sent home from work or school for asthma had been classified by their physicians as having "mild asthma."

For more information: Allergy and Asthma Network-Mothers of Asthmatics Inc., 2751 Prosperity Ave., Suite 150, Fairfax, VA 22031. Tel: 800-878-4403 or 703-641-9595. Fax: 703-573-7794.

Drug Delivery with Aradigm's Electronic Inhaler Comparable to IV
Morphine delivered via Aradigm Corp.'s (Hayward, CA) AERx electronic inhaler is comparable to intravenous morphine. Study results found that the blood level profiles of morphine in ten healthy volunteer subjects were similar for the two delivery methods including reproducibility and speed of delivery. The bioavailability of morphine delivered via the AERx system was 75% when compared to intravenous delivery, and peak serum levels of inhaled morphine were achieved in less than two minutes.

The AERx Pain Management System is being designed to treat breakthrough pain by providing rapid acting morphine by inhalation as the pain occurs.

For more information: Rick Thompson, President and CEO, Aradigm, 26219 Eden Landing Rd., Hayward, CA 94545. Tel: 510-783-0100. Fax: 510-783-0410.

Interim Data Positive in Clinical Trial of Nabi-StaphVAX
Based on an analysis of interim data from its pivotal clinical trial of Nabi-StaphVAX, Nabi (Boca Raton, FL) believes that statistical significance may be achievable at study end given the trend towards protection seen to date. The double-blinded, placebo-controlled trial, involving 1,800 end-stage renal disease patients on hemodialysis, has been fully accrued and will continue to completion. The company anticipates that final results will be available by next summer.

Nabi-StaphVAX is a proprietary capsular polysaccharide vaccine designed to provide protection against infections caused by the bacterium Staphylococcus aureus. It has been shown to provide protection against S. aureus infections in animal models, and the company's Phase II studies have shown that the vaccine induces high levels of functional antibody in both normal subjects and hemodialysis patients, with antibody titers persisting through 1 year or more of follow-up.

For more information: David J. Gury, CEO, Nabi, 5800 Park of Commerce Blvd. NW, Boca Raton, FL 33487. Tel: 561-989-5800 or 800-642-8874. Fax: 561-989-5801.

Companies Begin Clinical Trials of Evacet/Taxol Combination
The Liposome Co. Inc. (Princeton, NJ) has commenced clinical trials in collaboration with Bristol-Myers Squibb Co. (New York) to evaluate the safety and efficacy of the Liposome Co.'s Evacet in combination with Bristol-Myers Squibb's Taxol (paclitaxel) for the treatment of patients with metastatic breast cancer.

Taxol has shown significant activity in numerous clinical trials against breast and ovarian cancers, lung cancers, bladder cancer, prostate cancer, head and neck cancers, and Kaposi's Sarcoma. Evacet (previously TLC D-99) is a proprietary liposomal formulation of the anticancer drug doxorubicin. Studies have shown that Evacet, when used in combination with cyclophosphamide (CPA), has antitumor activity that was non-inferior to a combination of doxorubicin and CPA, but with reduced potential for cardiotoxicity.

For more information: James A. Boyle, Sr. VP of Medical and Regulatory Affairs, The Liposome Co. Inc., One Research Way, Princeton Forrestal Center, Princeton, NJ 08540. Tel: 609-452-7060. Fax: 609-452-1890.

Topligan Induces Erection in 75% of Clinical Trial Patients
Investigators from Northwestern University Medical School have reported that Topiglan, a topical drug under development by MacroChem Corp. (Lexington, MA), induced erection in 67 to 75% of impotent men tested, versus 17% of men receiving a placebo.

Topiglan treats erectile dysfunction with alprostadil, a naturally occurring compound that can relax disease-constricted penile blood vessels in impotent men. Before Topiglan, alprostadil had to be injected into the penis with a hypodermic syringe, or inserted into the urethra as a suppository.

For more information: MacroChem Corp., 110 Hartwell Ave., Lexington, MA 02173-3134. Tel: 781-862-4003. Fax: 781-862-4338.

Trials of Optison Myocardial Contrast Echocardiography Complete
Molecular Biosystems Inc. (San Diego) has completed myocardial perfusion Phase 2 studies of Optison and submitted the results to the FDA for review.

The Phase 2 clinical trials consisted of six studies in 376 patients from a broad spectrum of known or suspected coronary artery disease including exercise stress, pharmacologic stress, and patients with suspected acute ischemic syndrome presenting to the emergency room. In all of these studies Optison Myocardial Contrast Echocardiography (MCE) was found to compare favorably with the standard clinical test, whether Single Photon Emission Computed Tomography (SPECT) or coronary angiography.

For more information: Howard Dittrich, Executive VP, Molecular Biosystems Inc., 10070 Barnes Canyon Rd., San Diego, CA 92121-2789. Tel: 858-452-0681. Fax: 858-812-7600.

Results from Abetafen Pre-Clinical Studies Encouraging
Pre-clinical studies of Abetafen, a derivative of Bioenvision Inc.'s (London) breast cancer treatment Modrefen, suggest the compound could be efficient in the treatment of both benign and malignant prostate diesease. The pre-clinical results have enabled the company to commit to clinical trials and the development of the product.

The company anticipates commencing clinical trials for Abetafen by the end of the year. Both Abetafen and Modrefen modulate the estrogen receptor Beta (ERB) which is highly expressive in the prostate.

For more information: Christopher Wood, President and CEO, Bioenvision Inc. Tel: +44 171-839-7570.

Scios to Initiate Phase III Trial of Natrecor for aCHF
Scios Inc. (Mountain View, CA) is preparing for an upcoming 500-patient Phase III clinical trial, known as the VMAC (Vasodilation in the Management of Acute Congestive Heart Failure) trial. The VMAC trial is scheduled to begin in October 1999, and will enroll approximately 500 patients with acute congestive heart failure for treatment with Natrecor, placebo, or nitroglycerin.

The company is undertaking the VMAC study to satisfy the concerns raised in an April, 1999 non-approval letter from the FDA for Natrecor in the treatment of aCHF. Scios intends to complete the VMAC trial and obtain FDA approval within two years.

For more information: Dick Brewer, President and CEO, Scios Inc., 2450 Bayshore Pkwy., Mountain View, CA 94043-1173. Tel: 650-966-1550. Fax: 650-968-2438.