Archimedes Pharma Ltd., of Reading, UK, reported positive data from proof-of-concept trials for two intranasal development projects. Both the IN Apomorphine and IN Diazepam Phase I studies showed high bioavailablity, positive pharmacokinetics and good tolerability. The agents are in development to treat motor fluctuations, or "off episodes," in Parkinson's disease and acute repetitive seizures in refractory epilepsy, respectively.
CPEX Pharmaceuticals Inc., of Exeter, N.H., said its partner, Serenity Pharmaceuticals, of Pennsylvania, completed a Phase IIa study of an intranasal candidate using its drug delivery platform technology for an undisclosed urology drug. During that study, 41 of 43 patients treated showed a positive response to treatment. Serenity also completed an end-of-Phase II meeting with the FDA.
ExonHit Therapeutics SA, of Paris, said it completed patient enrollment in a Phase IIa trial of EHT 0202 in Alzheimer's disease. Results are expected in the fourth quarter. If positive, ExonHit plans to seek a partner for further development of EHT 0202, which is designed to work by stimulating the alpha-secretase pathway and has demonstrated neuroprotective and symptomatic effects in animal models.
GTx Inc., of Memphis, Tenn., said an independent data safety monitoring board recommended that the company continue as planned the pivotal Phase III trial of toremifene 20 mg in the prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia (PIN), following a planned safety review. Nearly 1,600 patients with high-grade PIN have been enrolled in the trial. The primary endpoint is a reduction in prostate cancer incidence. GTx anticipates conducting an efficacy analysis this summer.
Keryx Biopharmaceuticals Inc., of New York, reported results from an ongoing Phase I/II study of KRX-0401 (perifosine) in combination with Velcade (bortezomib, Millennium) with or without dexamethasone in patients with relapsed or refractory multiple myeloma, which showed that those who had previously relapsed on a bortezomib-based treatment had a median time to progression of 8.5 months. The median time to progression for all 73 evaluable study patients (both bortezomib relapsed and refractory) was 6.4 months. Data were presented at the International Multiple Myeloma Workshop in Washington.
Medivation Inc., of San Francisco, reported data from an ongoing Phase I/II trial of MDV3100, an androgen receptor antagonist, in castration-resistant prostate cancer patients, which showed that the drug has consistently demonstrated antitumor activity across dose levels and endpoints. Data stem from 114 patients who have been followed for 12 weeks or longer. Almost all patients with favorable circulating tumor cell (CTC) counts (four or less) at the start of treatment maintained favorable counts at week 12 (89 percent of chemotherapy-naïve patients and 100 percent of post-chemotherapy patients), while a significant number of patients with unfavorable CTC counts of five or higher at baseline converted to favorable counts of less than five at week 12 (73 percent of chemotherapy-naïve patients and 40 percent of post-chemotherapy patients). MDV3100 also produced significant prostate-specific antigen declines and radiographic control in both chemotherapy-naïve and post-chemotherapy patients.