• Advanced Life Sciences Holdings Inc., of Chicago, reported positive results from Trial CL07-001 of its once-a-day oral antibiotic, cethromycin. The trial evaluated the potential of cethromycin to cause a prolongation in electrocardiographic QT interval in accordance with FDA and ICH E14 guidelines. At the therapeutic and supratherapeutic doses, cethromycin showed no signal of any electrocardiographic effects, and the study supported a favorable cardiac safety profile.

• Amarillo Biosciences Inc., of Amarillo, Texas, said the FDA has allowed the investigational new drug application to test its low dose oral interferon in a Phase II hepatitis C clinical trial to go into effect. CytoPharm Inc., the company's partner in Taiwan, will fund and conduct a clinical trial of 144 chronic hepatitis C patients in Taiwan. The patients will receive one of two different dosages of oral human interferon alpha or placebo. The goal is to reduce relapse rate for patients who have completed the standard combination therapy.

• Archemix Corp., of Cambridge, Mass., will receive an undisclosed milestone payment from its collaborator Ophthotech Corp., of Princeton, N.J., triggered by Ophthotech's enrollment of the first volunteer in a Phase I study of E10030, an antiplatelet-derived growth factor aptamer, which is being developed for age-related macular degeneration. The trial will test the safety and tolerability of E10030 in combination with an antivascular endothelial growth factor agent. The trial will enroll up to a maximum of 36 patients.

• Can-Fite BioPharma, of Petach Tikva, Israel, has completed the first dose cohort of a Phase I clinical trial of CF102, a targeted drug that binds with high affinity to adenosine A3 receptor, CF102 binds to its target on cancer cells and triggers programmed cell death. Can-Fite currently intends to develop CF102 for the treatment of liver cancer and other liver diseases.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., has reached an agreement with the FDA on a special protocol assessment for the design of Study 301, a pivotal Phase III trial of Droxidopa in patients with neurogenic orthostatic hypotension. Chelsea plans to conduct two pivotal trials (Studies 301 and 302) evaluating a combined total of up to 236 patients. The primary endpoint for each trial will be a statistically significant improvement in symptomatic benefit between active and placebo. Chelsea expects to complete both studies by year-end 2008, allowing for a new drug application to be filed early in 2009.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, has filed an investigational new drug application to begin clinical trials with its oral drug candidate Apoptone (HE3235) for the treatment of hormone receptor sensitive cancers. The company plans to initiate a Phase I/II dose-ranging clinical trial in prostate cancer patients during the second quarter of 2008. The patient population for this initial clinical trial will be considered "late stage," which is defined as patients failing at least one round of chemotherapy.

• JADO Technologies GmbH, of Dresden, Germany, reported positive results from a Phase IIa clinical trial of its lead RAFT modulator TF002 in patients with severe atopic dermatitis. TF002, a topical formulation of miltefosine, exerts its anti-inflammatory activity via RAFT modulation. RAFTS are subcompartments in the lipid membrane of cells that play a role in the complex physiological processes, such as immune response. The randomized, double-blind, active (hydrocortisone) controlled study demonstrated that TF002 met its primary endpoint of significant reduction of inflammation in atopic skin.

• Phosphagenics Ltd., has initiated a clinical trial for its lead dermatological product, retinoic acid, a form of vitamin A. The trial follows preclinical studies that demonstrated both an increase in dermal absorption of retinoic acid when formulated with Phosphagenics' drug delivery platform and a significant reduction in irritation scores. The clinical trial is a double-blind study that will involve 90 subjects and is expected to be completed by the end of the second quarter.

• PLx Pharma Inc., of Houston, has initiated a Phase I clinical trial of PL 2100, also known as Aspirin-PC, its oral drug candidate for equivalent label claims for aspirin under a 505(b)(2) regulatory path. There are two active investigational new drug applications for PL 2100, for prescription and nonprescription uses, and the trial designed to address the regulatory requirements of both. The trial will evaluate the safety, tolerability, pharmacokinetics and anti-platelet equivalence of aspirin compared with PL 2100 Aspirin-PC at 325-mg and 650-mg dose levels.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the Therapeutic Product Directorate of Health Canada has issued a No Objection Letter to Spectrum's application to conduct clinical trials for EOquin, the company's drug candidate in Phase III trials in the U.S. for non-invasive bladder cancer. The study plan calls for two double-blind, placebo-controlled, randomized Phase III clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer.