• CeNeRx BioPharma Inc., of Research Triangle Park, N.C., completed its Phase I program for Tyrima, a reversible monoamine oxidase A inhibitor for depression and anxiety. Acute dose, repeat dose and fed-fasted Phase I trials showed the drug to be well tolerated in 65 patients with good pharmacokinetic properties. CeNeRx plans to begin a Phase II trial in the second quarter of 2008.
• Cerimon Pharmaceuticals Inc., of South San Francisco, initiated two Phase II/III trials of its once-daily topical diclofenac sodium patch for mild to moderate pain. Both studies are randomized, double-blind, placebo-controlled, 300-patient trials, with one focusing on pain associated with ankle sprains and the other focusing on pain associated with tendonitis or bursitis of the shoulder, elbow or wrist. Diclofenac patches are designed to avoid side effects associated with oral pain drugs and are used in Japan and several other countries.
• Epix Pharmaceuticals Inc., of Lexington, Mass., revised the previously released results from its Phase IIa trial of 5-HT4 agonist PRX-03140 in Alzheimer's disease. According to the new data, patients who received 150 mg PRX-03140 once daily achieved a 3.6 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog), compared to a 0.9 point worsening for placebo patients (p=0.021). Epix previously had said the treated group obtained a 5.7 point improvement, compared to a 0.2 point worsening for the placebo group. In both analyses, the drug was well tolerated and did not result in significant improvements when combined with Aricept (donepezil, Pfizer Inc.). Epix and partner London-based GlaxoSmithKline plc plan to initiate a Phase IIb trial in the first half of this year. Shares of Epix (NASDAQ:EPIX) fell 46 cents, or 13 percent, to close at $3.11 on Wednesday. (See BioWorld Today, Dec. 19, 2007.)
• Morria Biopharmaceuticals plc, of London, reported preliminary safety results from its Phase I study of MRX-4 in 16 allergic rhinitis patients showing that the nasally administered drug, given as a single dose once a week for four consecutive weeks resulted in no adverse effects observed in blood analysis. Pharmacokinetic data further indicated safety. The company plans to start a Phase II trial involving 175 patients who will be treated for six days prior to allergen challenge.
• SGX Pharmaceuticals Inc., of San Diego, initiated two Phase I trials of SGX523, an oral, small molecule inhibitor of the cMET receptor tyrosine kinase. The open-label, dose-escalation studies will evaluate continuous and intermittent dosing in advanced cancer patients.
• Summit Corp. plc, of Oxford, UK, initiated a Phase II trial with SMT D001 for sialorrhoea, a symptom of Parkinson's disease characterized by overproduction of saliva and uncontrollable drooling. The randomized, double-blind, placebo-controlled UK-based trial will enroll 40 patients and will evaluate the ability of SMT D001 to reduce saliva secretion rates. Data are expected in the third quarter. SMT D001 is a small molecule combining two off-patent drugs and is the lead candidate from Summit's drug reprofiling platform.