• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., in collaboration with Symphony Capital LLC, has initiated a Phase IIa proof-of-concept trial with AZ-104 (Staccato loxapine) in patients with migraine headache. AZ-104 is a lower dose version of AZ-004, which is being developed to treat acute agitation in patients with schizophrenia. The Phase trial is an in-clinic, multicenter, randomized, double-blind, single-administration, placebo-controlled study in approximately 160 migraine patients with or without aura. Three doses of AZ-104 (1.25 mg, 2.5 mg and 5 mg) will be evaluated against placebo in the clinical trial.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., submitted an investigational new drug application for ALTU-237, an orally-delivered, crystalline formulation of an oxalate-degrading enzyme for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones. Phase I trials will begin pending FDA approval of the IND.

• Array BioPharma Inc., of Boulder, Colo., presented data from Phase I trials of the MEK inhibitor ARRY-162 and the p38 inhibitor ARRY-797. In single ascending dose and multiple ascending dose studies, oral ARRY-162 inhibited the production of IL-1beta, TNF-alpha, IL-6 and phosphoERK (pERK). A Phase II study in rheumatoid arthritis is slated to begin by the end of this year. In a single ascending dose study, oral ARRY-797 inhibited the production of IL-1beta, TNF-alpha and PGE2. Additional Phase I studies are underway. The data were presented at the Annual European Congress of Rheumatology in Barcelona, Spain, and the International Association of Inflammation Societies' (IAIS) 8th World Congress in Copenhagen, Denmark.

• Avalon Pharmaceuticals Inc., of Germantown, Md., said interim data from a Phase I study of AVN944 in hematologic malignancies showed that the drug induced stable disease in almost half of the 39 evaluable patients after one month of treatment. Additionally, AVN944 was well tolerated and demonstrated dose-dependent pharmacokinetics and an induction of biomarkers associated with apoptosis. AVN944 is an oral small molecule that inhibits inosine monosphospate dehydrogenase (IMPDH), which is overexpressed in many cancer cells.

• Immtech Pharmaceuticals Inc., of New York, has completed the dosing and exposure protocol for a Phase II malaria prevention trial in the U.S. of its oral drug candidate pafuramidine (DB289). The study is designed to determine whether pafuramidine would be effective in preventing malaria infections for travelers. The primary purpose of the randomized, double-blind, placebo-controlled study is to determine whether pafuramidine can prevent the initial infection of the liver as well as infection of red blood cells associated with infection by Plasmodium falciparum.

• Metabasis Therapeutics Inc., of San Diego, initiated a Phase 1b hyperlipidemia trial with MB07811, an oral, thyroid hormone receptor-beta agonist targeted to the liver in an effort to reduce side effects. The 14-day, 60-patient, multiple-dose trial will evaluate safety and tolerability and may provide preliminary evidence of a reduction in serum cholesterol and triglycerides. Phase Ia data indicated a single dose of the drug was safe and well tolerated.

• Neoprobe Corp., of Dublin, Ohio, disclosed positive preliminary results from a Phase II study of its lead clinical candidate, Lymphoseek (technetium Tc99m DTPA-mannosyl-dextran). Lymphoseek is a radioactive targeting agent being developed for use with handheld gamma detection devices in a certain biopsy procedure. The primary endpoint of the open-label trial was 90 percent Lymphoseek localization to lymphoid tissue. Neoprobe said it is preparing to submit its Phase III pivotal trial protocol to FDA. Neoprobe's stock (OTC BB:NEOP) gained 6 cents Wednesday, or 29.4 percent, to close at 26 cents.

• Pharmos Corp., of Iselin, N.J., initiated a Phase IIb trial of dextofisopam in irritable bowel syndrome (IBS). The double-blind, randomized, placebo-controlled trial will evaluate three doses of dextofisopam in 480 women with diarrhea-predominant or alternating IBS. The primary endpoint of "adequate overall relief" of IBS symptoms was previously met in a Phase IIa study (p=0.033). Dextofisopam, an enantiomer of racemic (RS-) tofisopam, is marketed in 15 countries outside of the U.S.