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Apr 01, 2006

Indevus Pharmaceuticals, Inc. has completed enrollment of approximately 600 patients in the first of two phase III trials for its once-daily formulation of trospium chloride (Sanctura XR) for the treatment of overactive bladder.Enrollment of the second trial is expected to close in May 2006.

Enrollment closes in first of two trials for OAB drug

Indevus Pharmaceuticals, Inc. has completed enrollment of approximately 600 patients in the first of two phase III trials for its once-daily formulation of trospium chloride (Sanctura XR) for the treatment of overactive bladder.Enrollment of the second trial is expected to close in May 2006.

Both 12-week, double-blind, placebo-controlled studies will evaluate the efficacy of once-daily trospium in reducing the frequency, urgency, and incontinence episodes in patients with overactive bladder.

Indevus said it expects to file a new drug application with the FDA by the end of 2006.

Firms join to explore using PCA3 assay to detect PIN

GTx, Inc. has agreed to provide urine samples from its multicenter phase IIb and III clinical trials of toremifene citrate (Acapodene), 20 mg, for prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia (PIN), to Gen-Probe, Inc. Gen-Probe will use the samples to evaluate the ability of its research-stage PCA3 gene-expression assay to detect high-grade PIN.

Because PCA3 is highly overexpressed in malignant prostate cancer cells, its pattern of expression may be useful in identifying high-grade PIN, according to the companies.

Prostate biopsy currently is the only way to detect high-grade PIN, which has been shown to correlate highly with increased risk for prostate cancer development. Although 1.1 million American men have biopsy-confirmed high-grade PIN, an estimated 15 million are suspected to harbor the precancerous lesion, the companies said.

Phase III trials to begin for transdermal OAB agent

Pivotal phase III trials are expected to begin during the second half of this year for a once-daily topical formulation of oxybutynin (Anturol) for overactive bladder, according to its developer, Antares Pharma, Inc. The preliminary phase III plan will include a double-blind, randomized, placebo-controlled multicenter study evaluating the efficacy of the gel formulation in patients with urge and mixed urinary incontinence over 12 weeks. The plan has received FDA approval.

Results from a phase II clinical trial of the gel-based topical formulation have shown positive tolerability in at all doses when given to healthy volunteers. The adverse event profile of the gel formulation was reduced compared with both oral and transdermal adhesive patch formulations. Skin irritation from the gel affected 1.7% of volunteers compared with 50% in those who used the transdermal patch.

Genomic test developed to predict PCa, other cancers

GenoMed, a genomics research company, has announced development of Healthchip, a genomic test for predicting six common cancers, including prostate cancer. The test, which consists of several hundred single nucleotide polymorphisms (SNPs), has been shown to correctly identify at-risk patients 85% of the time, the company said.

GenoMed reports that several years of testing will be required before the test can be submitted for FDA approval.

Semen-based prostate cancer test in the works

Biotechnology companies Proteome Systems, Ltd. and Egenix Inc. have signed an agreement to co-develop a noninvasive semen test for prostate cancer.

Based on the proprietary Human Carcinoma Antigen (HCA), which signals the presence of cancer when found in blood, the test will measure the presence of HCA in semen. Compared with the current blood test for PSA, which has a high false-positive rate, HCA as a cancer marker has shown 100% sensitivity and a 17% false-positive rate in initial data testing.

Under the agreement, Egenix will fund test development, but will share future development and marketing rights of the test with Proteome. Egenix previously worked with the University of Rochester on the use of HCA as a diagnostic marker and therapeutic target for cancer.