• Addex Pharmaceuticals Ltd., of Geneva, terminated development of ADX10059 for chronic indications, including long-term treatment of gastroesophageal reflux disease and migraine prophylaxis after a preliminary review of the unblinded data from Study 206, which showed an incidence of alanine transaminase levels greater than five times the upper limit of normal. The ALT elevation occurred in all dose groups and appeared to be related to the duration of dosing. No abnormalities of liver function were observed in the placebo group. Addex, which said it has cash until the end of 2011, plans to focus its efforts on ADX48621, which is set to start Phase II testing in Parkinson's disease levodopa-induced dyskinesia in the fourth quarter of 2010.

• Advaxis Inc., of North Brunswick, N.J., will collaborate with the Gynecologic Oncology Group of the National Cancer Institute on a Phase II trial of lead candidate ADXS11-001 in advanced cervix cancer in women who have failed prior cytotoxic therapy. Advaxis will contribute the study drug and some funds to the cost of the trial, including the translational clinical immunology research. The company will update its investigational new drug application and file the final protocol with the FDA before the trial begins.

• Almac Discovery Ltd., of Craigavon, UK, started a Phase I trial of an intranasal Granisetron product using the ChiSys delivery technology from Nottingham, UK-based Archimedes Development Ltd., which is in development for chemotherapy-induced nausea and vomiting. The trial is expected to evaluate single doses of the product for safety, bioavailability and pharmacokinetics compared with oral and intravenous formulations of Granisetron. The study is set to be completed in early 2010.

• Amylin Pharmaceuticals Inc., of San Diego, Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Cambridge, Mass., reported positive results from a head-to-head study comparing exenatide once-weekly to Byetta (exenatide) injection taken twice daily in patients with Type II diabetes. After 24 weeks of treatment, patients in the once-weekly group experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for Byetta. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for the once-weekly exenatide group and 3 pounds in the Byetta group.

• BioAlliance Pharma SA, of Paris, gained approval from the French drug agency to start a Phase II trial of clonidine Lauriad in radiotherapy- and chemotherapy-induced oral mucositis. The company also gained approval from Danish and Slovene agencies to start a Phase I trial of AMEP in invasive melanoma.

• Biovitrum AB, of Stockholm, Sweden, said the first patient was dosed in a Phase I/II study of its long-acting fully recombinant Factor VIII Fc fusion protein. The open-label study will assess safety, tolerability and pharmacokinetics in severe, previously treated hemophilia A patients. The program is partnered with Cambridge, Mass.-based Biogen Idec Inc.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, initiated the regulatory process for a Phase II glaucoma trial in Israel testing CF101 vs. placebo. The first segment will enroll 44 patients with ocular hypertension or glaucoma to be treated for 16 weeks. The study will be expanded up to an additional 88 patients upon successful conclusion of an interim analysis. A decrease in intraocular pressure will be the efficacy measurement.

• Cardio3 BioSciences SA, of Mont-Saint-Guibert, Belgium, completed enrollment ahead of schedule in the first stage of its pivotal Phase II/III trial of C-Cure, a stem cell therapy for heart failure. Forty-five patients have been recruited to evaluate the safety of the cardiopoietic cells, with data available in May 2010. The second stage, which will recruit an additional 195 patients, is expected to start in the third quarter of 2010 and will test the safety and efficacy of C-Cure beyond optimal clinical care in patients with heart failure. It also will evaluate the socio-economic implications of therapy. C-Cure is produced by taking a patient's own bone marrow cells and differentiating them into cardiopoietic cells that can regenerate damaged heart muscle.

• Celgene Corp., of Summit, N.J., reported data from a 352-patient Phase IIb study of apremilast (CC-10004) in moderate to severe plaque-type psoriasis, showing that 41 percent of patients treated with 30 mg of oral apremilast twice daily achieved a PASI-75 after 16 weeks compared to 6 percent of patients receiving placebo. A dose-dependent effect was observed between the active therapy arms of the study, with 29 percent of patients receiving 20 mg twice daily achieving PASI-75 vs. 11 percent of patients in the 11-mg twice-daily group.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said the FDA agreed to allow the company to modify the primary endpoint and enroll an additional 24 patients in Study 301, its pivotal Phase III trial of Droxidopa in symptomatic neurogenic orthostatic hypotension. The new primary endpoint will be the relative mean change in the Orthostatic Hypotension Questionnaire composite score between Droxidopa and placebo arms. The additional patients will increase the power of the study to greater than 80 percent. Chelsea anticipates the study will complete enrollment by the end of the second quarter of 2010, allowing for top-line data in the third quarter. The company requested the amendment to the primary endpoint following the failure of the first Phase III trial, Study 302, which fell short of showing statistical significance, though the company later reported that Droxidopa bested placebo in several secondary endpoints. Since Study 302 cannot support the drug's approval, the FDA also recommended that Chelsea submit a confirmatory study to support a new drug application filing. (See BioWorld Today, Sept. 25, 2009, and Oct. 2, 2009.)

• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., recently held a Type A meeting with the FDA to discuss a randomized Phase III trial for its oral sapacitabine capsules in acute myeloid leukemia and, separately, in myelodysplastic syndromes. The company plans to submit a special protocol assessment request during the first quarter of 2010. Sapacitabine is an oral nucleoside analogue. Shares of Cyclacel (NASDAQ:CYCC) dropped 12 cents, to close Tuesday at $1.24.

• EpiCept Corp., of Tarrytown, N.Y., provided an update on its Ceplene (histamine dihydrochloride), including plans to initiate two new studies of the drug: a Phase I/II study testing Ceplene and low-dose interleukin-2 in combination with Gleevec (imatinib, Novartis AG) on eradication of minimal residual disease in adults with chronic myeloid leukemia, and a Phase II study of Ceplene/IL-2 plus Vidaza (azacitidine) vs. Vidaza alone in patients with higher risk myelodysplastic syndromes who have achieved hematological response to Vidaza.

• Generex Biotechnology Corp., of Worcester, Mass., said interim results from a Phase II study of the AE37 immunotherapeutic breast cancer vaccine, in development by its subsidiary Antigen Express Inc., showed that patients in the treatment arm had no relapses at a median follow-up of 13 months (zero of 49 patients) while relapses were observed in the control group (five of 71 patients). Those data were presented at the San Antonio Breast Cancer Symposium.

• Genomic Health Inc., of Redwood City, Calif., reported results from five studies of its Oncotype DX breast cancer test, including data showing that it predicted anthracycline-based chemotherapy benefit in women with ER+, N+ breast cancer and that use of the test led to fewer recommendations of chemotherapy for women with node-positive breast cancer.

• Lytix Biopharma A/S, of Tromso, Norway, gained approval from the Norwegian Medicines Agency and the Swedish Medical Products Agency to start Phase I testing of Oncopore (LTC-315) in cancer. The trial, set to start in 2010, initially will establish a safe and tolerated dose when injected into solid tumors.

• Pluristem Therapeutics Inc., of Haifa, Israel, said an independent data safety monitoring board approved the advancement to the intermediate dose level of the company's placenta-derived cell therapy, PLX-PAD, in the Phase I European trial for the treatment of critical limb ischemia. The study is designed to test the drug's safety at three dose levels. A total of up to 15 patients will be enrolled.

• QLT Inc., of Vancouver, British Columbia, started enrollment in a Phase Ib trial of QLT091001 in pediatric patients with Leber congenital amaurosis, an inherited progressive retinal degenerative disease. The trial will enroll eight patients, ages 5 to 14, to receive daily doses of the drug for seven days and will monitor for changes in several visual function parameters, including the best-corrected visual acuity over the duration of the study. QLT091001 is an oral, synthetic retinoid replacement for 11-cis-retinal.