• AmpliMed, of Tucson, Ariz., reported positive one-year survival results from a Phase I/II trial of its lead drug candidate Amplimexon (imexon for injection) in combination with dacarbazine in patients with unresectable stage III or stage IV metastatic malignant melanoma. Results from the full cohort of patients in both the Phase I and Phase II trials showed a 11.7 month overall mean survival for the entire patient set and a 22 month overall mean survival in the subset of patients with normal LDH levels. That compares to historical controls of eight months and 10 months, respectively, for patients treated with dacarbazine alone. The drug combination was well tolerated, with only 10.8 percent of patients showing myelosuppression and only seven patients having serious adverse events likely related to the study drug.

• Antigenics Inc., of New York, said Acambis plc, of Cambridge, UK, has released positive results from a Phase I study of its ACAM-FLU-A vaccine, which contains Antigenics' QS-21 Stimulon adjuvant. Based on those results, Acambis exercised its option for a commercial license to QS-21. Under terms of the agreement, Antigenics is entitled to future milestones and royalties for development and commercialization of the compound. QS-21 is an investigational adjuvant, which when added to vaccines and other immunotherapies is designed to enhance the body's immune response. Study results showed the compound was well tolerated and capable of stimulating an immune response. The highest immune response was observed in the group vaccinated with ACAM-FLU-A plus QS-21 adjuvant. In that group, 90 percent of subjects generated virus-specific antibodies following immunization. Financial terms were not disclosed.

• Avexa Ltd., of Melbourne, Australia, started a Phase III program for apricitabine (ATC), its HIV drug, following positive feedback from regulatory agencies. The Phase III trials, to be conducted in North and South American, Europe, Africa and Asia, will compare ATC to the standard of care in HIV patients whose disease is resistant to current drugs. The company also reported that all patients in the Phase IIb study have completed the 48-week dosing period, with final trial results expected later this quarter. All except one of the eligible patients entered the extension study.

• EntreMed Inc., of Rockville, Md., said the FDA accepted its investigational new drug application for its aurora kinase/angiogenesis inhibitor, ENMD-2076. It is a novel, dual-acting, kinase inhibitor against Aurora A and tyrosine kinases linked to promoting cancer and inflammatory diseases. The company said it plans to initiate several clinical studies with ENMD-2076, including Phase I trials in both solid and hematological cancers in 2008.

• GenVec Inc., of Gaithersburg, Md., has reached an agreement with the FDA to implement changes to its Phase II/III pancreatic cancer clinical trial (PACT study) with TNFerade in patients with locally advanced pancreatic cancer. The changes include measuring overall survival as the primary efficacy endpoint, rather than 12-month survival. No increase in study size will be required, and a benefit in overall survival can be considered as a basis for full regulatory approval of TNFerade for that indication. Also, the company will conduct two additional interim analyses of overall survival following one-third (92) and two-thirds (184) of the total events (deaths) for the study, with the potential to stop the trial if there is clear evidence of the drug's efficacy.

• Isotechnika Inc., of Edmonton, Alberta, enrolled the last patient in its six-month Phase IIb kidney transplant trial, which is designed as a non-inferiority study to test ISA247 compared to tacrolimus in biopsy-proven acute rejection episodes. The 334-patient trial also will monitor kidney function and laboratory parameters, and the study's overall goal is to find the most appropriate dose. Patients who have completed the six-month trial were provided the opportunity to continue treatment with ISA247 as part of an extension study aimed at providing longer-term safety and efficacy data in de novo kidney transplant patients.

• Nicox SA, of Paris, said Pfizer Inc., of New York, began a dose-ranging Phase II trial in Japan with the glaucoma therapy PF-03187207. The trial will enroll about 120 patients in a 28-day, double-blinded trial. The drug is the first candidate to emerge from a deal signed by Nicox and Pfizer in 2004, and expanded later. (See BioWorld Today, March 3, 2006.)

• Oculus Innovative Sciences Inc., of Petaluma, Calif., completed patient treatment and follow-up in its Phase II study of its Microcyn Technology in mildly infected diabetic foot ulcers. The final patient evaluation occurred Dec. 24, and the firm anticipates reporting top-line data this quarter. The 67-patient study involved three treatment arms - topical Microcyn alone, topical Microcyn in combination with oral levofloxacin or topical saline in combination with oral levofloxacin - and is designed to provide a clinical basis for larger Phase III studies.

• Oncolytics Biotech Inc., of Calgary, Alberta, said the National Cancer Institute filed a protocol with the FDA for a Phase I/II trial in patients with metastatic ovarian, peritoneal or fallopian tube cancers using concurrent systemic and intraperitoneal administration of Reolysin, Oncolytics' proprietary formulation of the human reovirus. The NCI is sponsoring the trial under an agreement with Oncolytics, which will provide supplies of the drug, and the study in as many as 70 patients will be carried out at the Ohio State University Comprehensive Cancer Center.

• Protox Therapeutics Inc., of Vancouver, British Columbia, reported final results from its Phase I study of PRX302 in benign prostatic hyperplasia indicating that the drug is safe and well tolerated, with promising signs of therapeutic activity. Data from the 15-patient study showed that, despite a 14-fold escalation in dose, no safety issues were identified and the maximum tolerated dose was not reached. The company reported that treatment-related symptomatic relief was rapid and that substantial benefits were noticed by day 30 post-treatment. Both symptom scores, as measured by the IPSS (international prostate symptom score) and QoL (quality of life) scores, continued to show further improvements in all cohorts at the end of the active study period, or 90 days post-treatment. PRX302 was developed using Protox' PORxin technology platform, which creates pore-forming prodrugs that are activated by specific proteases at elevated levels on the surface of target cells.

• Tengion Inc., of East Norriton, Pa., said it is starting its third Phase II trial of its Neo-Bladder Augment derived from a patient's own cells. The study is expected to involve 10 adult patients with non-neurogenic overactive bladder who are intolerant or not adequately responsive to medical therapy. Each Neo-Bladder Augment will be constructed using the patient's healthy cells from a biopsy and, in the space of about four to eight weeks, expanded cells will be seeded on a biodegradable scaffold to produce the augment for surgical implantation back into the patient's native bladder during an augmentation cystoplasty procedure. In addition to safety, the trial is designed to assess efficacy through a change from baseline in man number of micturitions, or urinations, per day, according to patient diaries, at 12 months, followed by a 48-month long-term evaluation. Tengion expects to complete trial enrollment this year.

• Theravance Inc., of South San Francisco, and partner GlaxoSmithKline plc, of London, started large Phase IIb asthma dose-optimization studies with both the lead inhaled corticosteroid GW685698 and the long-acting beta agonist (LABA) GW642444 assets to develop a next-generation combination product. Patients with mild to severe asthma are being enrolled in the GW685698 Phase IIb trial, while the Phase IIb program for GW642444 will involve about 600 patients with persistent asthma. Both programs will determine the most effective doses to move into Phase III combination studies. A separate Phase IIb program of GW642444 in chronic obstructive pulmonary disease also is set to begin in the first half of this year.

• XenoPort Inc., of Santa Clara, Calif., started separate Phase II trials of XP19986 in patients with gastroesophageal reflux disease (GERD) and in spinal cord injury patients with spasticity. The GERD trial will evaluate the drug in patients with symptomatic disease and will measure the difference in the total number of heartburn episodes experienced by each subject over the treatment period compared to placebo as the primary endpoint. The spasticity study will evaluate a sustained-release formulation of the drug, with the primary outcome measure defined by assessment of muscle tone using the Ashworth Scale. XenoPort also initiated the first trial of XP21279, a drug candidate for Parkinson's disease. That study is expected to enroll 12 healthy subjects and will test the drug's pharmacokinetic profile in combination with carbidopa vs. Sinemet (L-Dopa/carbidopa) treatment. Preliminary results from the Phase I study are expected later this quarter.