• Ambit Biosciences Corp., of San Diego, dosed the first patients in its Phase I trial of AC220 in acute myeloid leukemia. The study is expected to enroll between 20 and 40 patients with relapsed or refractory AML to receive AC220 daily via oral solution, beginning at 12 mg for 14 days and then increasing until the maximum tolerated dose is established. In addition to evaluating safety, tolerability and pharmacokinetics, the trial will measure pharmacodynamics by monitoring FLT3 receptor phosphorylation and peripheral blood blast counts. AC220 is designed to inhibit FLT3, a kinase that is mutated in about one-third of AML cases, and patients with that mutation tend to be less responsive to traditional therapies.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., said that Pfizer Inc., of New York, has completed patient enrollment in two pivotal Phase III clinical trials of the Toll-like receptor 9 (TLR9) agonist drug candidate, PF-3512676, for the treatment of advanced non-small-cell lung cancer. More than 1,600 patients with Stage IIIB/IV disease are enrolled in these trials. Coley and Pfizer entered into an exclusive global license agreement in March 2005 to develop, manufacture and commercialize TLR9 for the control and prevention of cancer. Both trials are being conducted under the FDA's special protocol assessment procedure.

• CoMentis Inc., of South San Francisco, has initiated a Phase II trial of ATG3, a topical eye drop therapy for neovascular age-related macular degeneration. An ophthalmic formulation of mecamylamine, ATG3 is an antagonist of the nicotinic acetylcholine receptor pathway that mediates angiogenesis. The drug was developed to penetrate into the retina and choroid following topical eye drop administration. The Phase II study will be a double-masked, placebo-controlled trial to evaluate the safety and efficacy of ATG3 in patients with NV-AMD. The 48-week trial involves 330 patients randomized to three treatment groups, administered by eye drop twice daily. In a Phase I trial, ATG3 demonstrated excellent ocular tolerability, minimal systemic exposure following administration of the eye drops and no side effects.

• EpiCept Corp., of Tarrytown, N.Y., has initiated two Phase IIb trials with EpiCept NP-1, a topical prescription analgesic cream for peripheral neuropathies. The first trial is a 200 patient, placebo-controlled study of NP-1 in patients with diabetic peripheral neuropathy. The primary endpoint for this trial is the change in pain intensity over the four week duration of the trial. Preliminary results are expected by the fourth quarter of 2007. The second trial is a 500-patient, placebo- and active-controlled trial in peripheral herpetic neuropathy comparing the efficacy and safety of NP-1 vs. gabapentin, as well as placebo. The primary endpoint for the trial is the change in pain intensity over the four week duration. Preliminary results are expected in the first quarter of 2008.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., reported positive results from its initial Phase I trial of PS433540, its lead internal candidate for hypertension and diabetic nephropathy. Data showed that the drug was well tolerated at all six doses administered, and findings suggested that the compound possesses linear pharmacokinetics and a half-life that is consistent with once-daily administration. PS433540 is a dual-acting angiotensin and endothelin receptor antagonist (DARA). Pharmacopeia said it will move forward with additional Phase I studies, including a multiple ascending-dose study, and expects to complete Phase I work in late 2007, with plans to start Phase II in the first half of 2008.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, announced positive interim results from a Phase IIa safety trial for NTx-265, its combined treatment for acute stroke. Four of five subjects safely completed a regimen initiated 24 to 48 hours after stroke with no drug-related serious adverse events, while showing substantial recovery. A fifth study patient died before dosing was completed of causes unrelated to the treatment.

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