• A.P. Pharma Inc., of Redwood City, Calif., said it probably would not meet a previously announced target of a 2007 filing of its new drug application for APF530, due to a slower-than-expected rate of sites being activated in the ongoing 1,350-patient Phase III trial. About 80 percent of the planned 80 sites now are active. APF530, which contains the 5HT3 antagonist granisetron formulated with the company's Biochronomer bioerodible drug delivery system, is in development for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. News of the delay caused A.P.'s stock (NASDAQ:APPA) to fall 29 cents Thursday, or 19.3 percent, to close at $1.21.

• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., completed enrollment in and announced top-line results from a Phase I trial of AZ-003 (staccato fentanyl), an inhaled formulation of the opioid analgesic fentanyl for acute pain treatment. The inhaled formulation demonstrated similar pharmacokinetic characteristics to fentanyl administered intravenously, as well as dose-proportionality. There were no serious adverse events attributable to AZ-003.

• Bavarian Nordic A/S, of Kvistgard, Denmark, said preliminary results from a Phase II study of Imvamune demonstrated that the product is equally well tolerated in HIV-infected patients and healthy subjects. The immunogenicity data also revealed that 96 percent of HIV-infected patients previously not vaccinated against smallpox had a detectable antibody response two weeks after the Imvamune boost vaccination, which was equivalent to the healthy control group. The study involved 91 HIV patients and 60 healthy subjects.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, announced results from the first two stages of the three-part Phase Ib trials of its hematological drug candidate, CTCE-0214. CTCE-0214 has the potential to restore a cancer patient's immune system and blood cells between cycles of chemotherapy. A total of 57 healthy patients were evaluated using various doses and comparing intravenous vs. subcutaneous routes of administration. Results demonstrated that CTCE-0214 was safe and well tolerated when administered intravenously, and no side effects were reported. Subjects receiving subcutaneous doses did report transient injection-site reactions and local pain.

• Dynavax Technologies Corp., of Berkeley, Calif., initiated a pivotal Phase III trial of Heplisav, its hepatitis B virus vaccine in Canada. Sites in the U.S. and Europe are scheduled to participate in the study and are expected to begin dosing patients in early 2007. The multicenter trial, known as PHAST (Phase 3 Heplisav Short-Regimen Trial), will compare a two-dose regimen of Heplisav administered at 0- and 1-month to the conventional three-dose regimen of Engerix-B. The enrollment target of the study is 1,740 subjects ages 11 to 55 years. Dynavax anticipates that the trial will be completed in 2008 and intends to use the data to support registration. Previously reported clinical trial results have shown 100 percent seroprotection after two doses in subjects 18 to 39 years of age, and after three doses in subjects 40 to 70.

• Emergent BioSolutions Inc., of Gaithersburg, Md., signed a clinical trial agreement with the National Institute of Allergy and Infectious Diseases (NIAID), under which NIAID will fund, manage and conduct a clinical study on EBS-C12, as well as EBS-A42. Both EBS-C12 and EBS-A42 are novel recombinant proteins that have been selected for use in the company's group B streptococcus vaccine candidate. Under the agreement, NIAIS will conduct a Phase I, open-label, does-escalating study to evaluate the safety, tolerability and immunogenicity of EBS-C12 and EBS-C12 in combination with EBS-A42. Results are expected in 2008.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application to the FDA for XL518, a specific inhibitor of MEK, a key component of the RAS/RAF/MEK/ERK pathway. Inappropriate activation of the pathway is a prevalent feature of tumor cells and drives tumor growth and survival.

• iCo Therapeutics Inc., of Vancouver, British Columbia, filed an investigational new drug application with the FDA for iCo-007 in eye diseases including age-related macular degeneration and diabetic retinopathy. iCo-007 is an antisense drug that inhibits c-Raf. Isis Pharmaceuticals Inc., of Carlsbad, Calif., developed the drug and will receive a milestone payment due to the IND filing.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., filed an investigational new drug application with the FDA for its eye-drop formulation of bepotastine for allergic conjunctivitis. ISTA plans to start a Phase II/III trial with the drug in the first quarter of 2007, based on existing early stage clinical research conducted in Japan. An oral formulation of bepotastine has been approved in Japan for treatment of allergic rhinitis since July 2000.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., reported positive results from a dose-ranging study designed to evaluate the pharmacokinetic parameters, appetite, food intake and safety of various doses of its proprietary PYY(3-36) nasal spray in obese subjects. The double-blind, cross-over clinical trial treated 24 patients with a body mass index of 30-40 kg/m2. In those subjects, PYY nasal spray produced a statistically significant treatment effect and a reduction in calorie intake. Nastech plans to advance its clinical obesity program in 2007 by performing Phase II efficacy and safety trials.

• Pherin Pharmaceuticals Inc., of Redwood City, Calif., said results from a 60-patient Phase II trial showed that PH80, a compound administered intranasally, had significant benefits in the treatment of symptoms of PMS. Data demonstrated that the drug reduced premenstrual symptoms in 63 percent of patients as compared to placebo (44 percent) during the treatment phase. Based on those positive data, Pherin said it is programming a pivotal Phase III trial to evaluate PH80 in patients with PMS.

• Point Therapeutics Inc., of Boston, said finalized data from its 55-patient Phase II study of talabostat in combination with docetaxel in Stage IIIb/IV non-small-cell lung cancer showed an overall median progression-free survival of four months and an overall median survival of 7.8 months. Talabostat is in two ongoing Phase III studies, with results expected by the end of 2007 and a possible new drug application filing in early 2008.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., initiated the second of two global, pivotal Phase III trials of intravenous methylnaltrexone in post-operative ileus (POI). The first Phase III trial was initiated in September. POI is a temporary impairment of gastrointestinal function characterized by abdominal bloating and pain, nausea and vomiting, and an inability to pass gas or stool. The second study will enroll about 500 patients who have undergone segmental colectomy surgery in a double-blind, randomized, placebo-controlled clinical trial at about 75 to 90 surgical centers worldwide.

• Repros Therapeutics Inc., of The Woodlands, Texas, said interim results from a Phase II study of Proellex suggested that patients treated with the drug show a statistically significant improvement in symptoms associated with uterine fibroids. The company closed enrollment in the 128-patient study, which is designed to compare two doses of Proellex - 12.5 mg and 25 mg - to placebo. The study's primary endpoint is a reduction in menstrual bleeding, a common symptom of uterine fibroids.

• Sunesis Pharmaceuticals Inc., of South San Francisco, started dosing patients in an open-label, multicenter Phase II trial of SNS-595 as a second-line agent in patients with ovarian cancer who have failed first-line platinum therapy. SNS-595 is a cell-cycle modulator and is in Phase II trials for non-small-cell and small-cell lung cancer, as well as a Phase I trial in acute leukemia.

• Tibotec Pharmaceuticals Inc., of Cork, Ireland, filed an application with European regulatory authorities to begin a Phase I trial of an HCV NS3/4A protease inhibitor. The study is expected to begin during the first quarter of 2007. The news triggered a €2.5 million (US$3.3 million) milestone payment to Tibotec's partner, Medivir AB, of Stockholm, Sweden.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and Merck & Co. Inc., of Whitehouse Station, N.J., started a pivotal Phase II study of MK-0457 (VX-680), a small-molecule inhibitor of Aurora, FLT-3, JAK-2 and BCR-ABL kinases. The study is expected to enroll about 270 patients with advanced chronic myelogenous leukemia and acute lymphocytic leukemia, all harboring the T3151 BCR-ABL mutation. MK-0457 will be given as a five-day intravenous infusion every two to three weeks to evaluate safety and efficacy. Merck said it may seek marketing approval for the drug based on data generated in the trial. In connection with the Phase II trial, Vertex earned a $25 million milestone payment from Merck.