• 7TM Pharma A/S, of Horsholm, Denmark, said data from a double-blind, placebo-controlled, dose-ranging Phase I/II obesity trial showed that Obinepitide effectively inhibits food intake. Obinepitide is an analogue of two hormones involved in appetite regulation. Data from a Phase II trial are expected in the first quarter of 2008.

• Ardea Biosciences, of Carlsbad, Calif., said it has started a new clinical development program directed toward the treatment of gout, a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream.

• BioAlliance Pharma SA, of Paris, said it has extended its ongoing acyclovir Lauriad Phase III trial in the treatment of oral herpes to the U.S. The 10 U.S. clinical centers will join the more than 40 in Australia and Europe already participating in the trial, with a target of 640 patients. The healing time of herpes lesions after taking a single acyclovir Lauriad tablet will be compared with placebo. The company anticipates submitting market authorization applications in the first half of 2009 in Europe and in the U.S., subject to additional regulatory requirements. In addition, the firm said it is opening additional European centers for its Phase III doxorubicin transdrug trial in primary liver cancer.

• BioMarin Pharmaceutical Inc., of Novato, Calif., filed an investigational new drug application (IND) with the FDA for phenylketonuria (PKU) treatment PEG-PAL (Poly Ethylene Glycol-Phenylalanine Ammonia Lyase), formerly known as Phenylase. A Phase I/II dose-escalation trial is slated to begin in the first quarter of 2008. BioMarin's lead PKU drug, Kuvan (sapropterin dihydrochloride), is under FDA review with an approval decision expected Dec. 14, pushed back from an original action date of Nov. 25 due to FDA staffing issues. (See BioWorld Today, May 25, 2007.)

• Genmab A/S, of Copenhagen, Denmark, said it has enrolled 132 patients into its pivotal trial of ofatumumab (HuMax-CD20) for refractory chronic lymphocytic leukemia (CLL). Enrollment in the trial is ongoing, but the 132-patient cohort will provide the basis for a 24-week efficacy interim analysis. Ofatumumab, which is partnered with GlaxoSmithKline plc, of London, also is in Phase III trials for refractory follicular non-Hodgkin's lymphoma and rheumatoid arthritis. (See BioWorld Today, July 11, 2006, and Nov. 21, 2007.)

• Geron Corp., of Menlo Park, Calif., said it has enrolled its first patient in a Phase I/II clinical trial of GRN163L, a telomerase inhibitor, in multiple myeloma. The trial is the fourth under way involving the product. The primary objective is to determine the safety and maximum tolerated dose of GRN163L when administered intravenously in patients with multiple myeloma who have failed at least two courses of standard chemotherapy. In addition, researchers will perform correlative laboratory studies on primary patient samples to characterize the effects of GRN163L on myeloma cancer cells.

• Immutep SA, of Orsay, France, reported positive interim results from a Phase I/II study of ImmuFact IMP321 in patients with metastatic breast cancer. The drug is given the day after paclitaxel chemotherapy, and in the first cohort of eight patients, data showed strong increases in the number of monocytes and CD8-positive T cells and associated clinical responses. Those data were presented at the biological therapy of cancer meeting in Boston.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., reported positive results from its Phase II octreotide implant trial in patients with acromegaly, a disorder characterized by excessive blood levels of growth hormone and insulin-like growth factor-1. Results showed that the implant, which uses the company's Hydron technology to deliver levels of synthetic peptide octreotide for six months, effectively suppressed levels of GH and IGF-1 at rates similar to those seen with FDA-approved injectable formulations of octreotide. The drug also was well tolerated. The company plans to move the program into Phase III in the first half of 2008.

• Inspire Pharmaceuticals Inc., of Durham, N.C., initiated a Phase III trial of epinastine nasal spray in seasonal allergic rhinitis. The 14-day study will enroll about 750 subjects who have documented histories of seasonal allergic rhinitis to mountain cedar pollen, who will be randomized to receive either one of two concentrations of epinastine (0.1 percent or 0.15 percent) at two different spray volumes or placebo. The primary efficacy endpoint is the average change from baseline over the treatment period for the reflective Total Nasal Symptom Score, defined as the sum of scores for runny nose, itchy nose and sneezing. Secondary endpoints will include change in nasal and ocular symptoms, quality-of-life parameters and safety. Inspire anticipates reporting top-line results from the trial in the second quarter of 2008.

• Isolagen Inc., of Exton, Pa., said the FDA recommended further analysis of the company's program to evaluate Isolagen Therapy for the treatment of moderate to severe acne scars. In response, Isolagen proposed amending its pivotal Phase III trial initiated earlier this month to a Phase II/III trial. Isolagen Therapy is a cellular processing system that multiplies a patient's fibroblasts to create an autologous treatment. it also is in Phase III for wrinkles.

• Kiadis Pharma BV, of Amsterdam, the Netherlands, said early results from the first three patients in an ongoing Phase II study of ATIR in graft-vs.-host disease demonstrated technical feasibility of the semi-closed cell processing system developed for the study and has resulted in no acute GVHD in patients so far. An early donor-dominated immune cell chimerism was observed: an indication for the functionality of the ATIR-treated immune cells. Though still early, none of those high-risk cancer patients has relapsed to date. ATIR is designed to selectively eliminate immune cells that otherwise could attack the patient's body following allogeneic bone marrow transplantation. Results were presented at the AABB meeting in Anaheim, Calif.

• Manhattan Pharmaceuticals Inc., of New York, published data from a randomized, controlled, single-blind, 73-patient clinical trial comparing Hedrin to malathion in the treatment of head lice. Manhattan's Hedrin achieved a statistically significant cure rate of 70 percent compared to 33 percent with malathion. The data were published in the November issue of PLoS One, a journal published by the Public Library of Science. Hedrin is marketed in Europe, and Manhattan plans to initiate the process of seeking FDA approval under a device pathway later this year.

• Merck Serono SA, of Geneva, and partner Newron Pharmaceuticals SpA, of Bresso, Italy, started a new Phase III study of safinamide as an add-on therapy to dopamine agonist treatment in Parkinson's disease patients. The six-month MOTION (SafinaMide add-On To dopamine agonist for early Idiopathic ParkinsOn's disease) study will evaluate two dose regimens of safinamide (50 mg and 100 mg once daily) with a dopamine agonist vs. dopamine agonist monotherapy. The study is expected to enroll more than 650 patients who have been treated with a stable dose of a single dopamine agonist for at least four weeks. The primary endpoint is the change in motor symptoms assessed by the change in the Unified Parkinson's Disease Rating Scale Part III score from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, cognitive functions, global clinical status and health-related quality of life. Safinamide previously failed to show statistical significance in an earlier Phase III trial in early stage Parkinson's patients, as reported in August, though Merck Serono and Newron said data indicated a lack of adequate response in patients in the higher dosage group, receiving 150 mg to 200 mg. (See BioWorld Today, Aug. 23, 2007.)

• Sosei Group Corp., of Tokyo, said it has received UK regulatory clearance to begin two pivotal Phase III trials with AD 923, a fentanyl sublingual spray for breakthrough cancer pain. Patient enrollment is expected to begin before the end of the year, and Sosei is seeking approval to expand the trial into other European countries.

• Transport Pharmaceuticals Inc., of Framingham, Mass., said that results of a Phase II study of its drug-device product, the SoloVir Electrokinetic Transdermal System, demonstrated that treatment at the erythema or papule-edema stages, the first visible signs of a cold sore, decreased the number of patients who progressed to classical lesions, and resulted in a dramatic decrease in healing times. Patients who were treated earlier, at the prodrome stage, did not see a statistically significance benefit.

• Valeant Pharmaceuticals International, of Aliso Viejo, Calif., enrolled the first patient in its randomized, double-blind, placebo-controlled, 180-patient Phase IIa trial of retigabine for pain associated with postherpetic neuralgia. Retigabine, a neuronal potassium channel opener, also is being studied in Phase III as an adjunctive treatment for patients with partial-onset seizures.

• Zosano Pharma Inc. (formerly Macroflux Corp.), of Fremont, Calif., completed enrollment in its Phase II trial of a parathyroid hormone (hPTH 1-34) transdermal microprojection delivery system to treat postmenopausal women with osteoporosis. Data are expected in the second half of 2008. PTH currently is available as an injection to build bone mass, but Zosano's delivery system is needle-free and does not require refrigeration.

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