AspenBio Pharma Inc., of Castle Rock, Colo., said results from ongoing research and clinical studies show that its human appendicitis blood test appears able to identify patients with appendicitis at a very high sensitivity level of 94 percent to 97 percent, compared to significantly lower diagnostic success rates for CT scans. Three studies have been conducted during the past 30 months, with one 400-patient study still ongoing. AspenBio anticipates a regulatory filing with the FDA later this

Aastrom Biosciences Inc., of Ann Arbor, Mich., said that 90 percent of patients who have completed the 12 months post-treatment follow-up a Phase I/II trial evaluating the use of Tissue Repair Cells in the treatment of severe long bone fractures had multiple bone bridges, evidence of bone regeneration. Twenty of 36 patients in the trial had completed 12-month follow-up. TRCs are a mixture of stem and progenitor cells derived from the patient's bone marrow. ChemGenex Pharmaceuticals Ltd., of

AndroScience Corp., of San Diego, successfully completed an investigational new application filing and intends to begin a Phase I trial this quarter of the acne product ASC-J9, a topical anti-androgen agent. AndroScience also has drug candidates in preclinical testing for alopecia, prostate cancer, benign prostate hyperplasia and other androgen-related disorders. BioLineRx Ltd., of Jerusalem, successfully completed Phase I trials of its lead product, BL-1020, a GABA-enhanced antipsychotic for

Adolor Corp., of Exton, Pa., initiated a Phase I trial with ADL5859, an oral Delta opiod agonist that may be used to treat pain and other conditions. The multi-dose trial will involve twice-daily dosing for seven days in healthy volunteers. Last fall, Adolor suffered a series of setbacks including an approvable letter requesting more safety data for Entereg (alvimopan) in postoperative ileus, two trial failures with Entereg in opioid-induced bowel dysfunction, and the discontinuation of

Argos Therapeutics of Durham, N.C. has began a Phase I/II trial to gauge the immunologic activity and safety of AGS-004 in HIV-infected adults. The study group will be 10 patients with durable viral suppression from highly active antiretroviral therapy. AGS-004 is a personalized RNA-loaded dendritic cell-based immunotherapy designed to stimulate the immune system to target and destroy the patient's unique viral burden. The primary study objective is to evaluate patient-specific anti-viral

Advanced BioHealing Inc., of New York, said it enrolled the first patient in its initial Celaderm pilot study. The primary goal is to evaluate the safety of Celaderm, a next-generation bioengineered tissue product. The study also will assess the potential for Celaderm to accelerate healing of venous leg ulcers compared with optimal standard therapy. The study is designed to enroll 55 patients. Amarillo Biosciences Inc., of Amarillo, Texas, said it began enrolling patients in a Phase II trial

Aida Pharmaceuticals Inc., of Hangzhou, China, announced that the company's researchers have published an article titled "Phase I Clinical Trial of Recombinant Human Apo-2 Ligand (Rh-Apo2L) in Patients with Advanced Cancer," in the Chinese Journal of New Drugs. The article was written by company researchers, scientists and medical professionals from the Department of Medical Oncology of the Cancer Hospital at the Chinese Academy of Medical Sciences and the Peking Union Medical College in

Avigen Inc., of Alameda, Calif., reported positive findings from a Phase IIa safety and tolerability study of AV411 (ibudilast), an oral therapy for neuropathic pain, in normal volunteers. Results also support a twice-daily dosing frequency. The company continues to enroll patients in the study, which is expected to be completed later in 2007. BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said European regulators granted orphan drug status to Fodosine, a transition-state analog

Adeza Biomedical Corp., of Sunnyvale, Calif., said the FDA granted orphan drug designation for Gestiva, the company's therapeutic candidate for preventing preterm birth in women with a history of preterm births. The designation would guarantee Adeza seven years of marketing exclusivity upon approval of the drug. Argos Therapeutics Inc., of Durham, N.C., said it began dosing in a Phase I/II trial to test the activity and safety of AGS-005 in B-cell chronic lymphocytic leukemia. AGS-005 is a

Including XL418, Exelixis now has 11 compounds in or ready to enter the clinic, including four compounds in Phase II, and plans to file at least three more INDs this year

Advanced Viral Research Corp., of Yonkers, N.Y., began a Phase II study using a topically applied spray formulation of AVR 118 as a wound healing agent. One cohort of patients will be treated after plastic surgery. The product will be applied to one of their wounds, and their second wounds will serve as an untreated control to determine if AVR 118 can accelerate the time taken for the wound to close and reduce or eliminate subsequent scar formation. A second cohort of patients will be treated

Crucell NV, of Lieden, the Netherlands, said it completed a Phase I study of the alum-adjuvanted formulation of its whole inactivated West Nile vaccine, which was manufactured using its PER.C6 technology. The trial in 47 subjects in Belgium demonstrated safety and tolerability. Cytos Biotechnology AG, of Zurich, Switzerland, said a placebo-controlled Phase IIa trial of the hypertension vaccine CYT006-AngQb showed a reduction in daytime blood pressure. The study was conducted in 72 patients

DOR BioPharma Inc., of Miami, said data from its pivotal Phase III trial showed that orBec (oral beclomethasone dipropionate) demonstrated continued survival benefit when compared to placebo in patients with gastrointestinal graft-vs.-host disease one year after randomization. Overall 18 patients (29 percent) in the orBec group and 28 patients (42 percent) in the placebo group died within one year. Those results were published in an on-line edition of Blood. MediciNova Inc., of San Diego

Bionovo Inc., of Emeryville, Calif., began enrollment in a pharmacokinetics trial to further evaluate its lead drug candidate, MF101, which is designed to treat the symptoms of menopause. The product also is being tested in Phase II trial in 217 postmenopausal women, which began in October. Penwest Pharmaceuticals Co., of Danbury, Conn., began a Phase I study of Nalbuphine ER, a nalbuphine hydrochloride extended-release tablet formulation being developed for pain. The trial will evaluate the

Alexza Pharmaceuticals Inc., of Palo Alto, Calif., completed patient enrollment in its Phase IIa trial of AZ-004 (Staccato loxapine), an inhalation candidate for acute treatment of agitation in schizophrenic patients. The study involved 120 subjects, with the primary aim of assessing the safety and efficacy of a single dose, as determined by the change in the PANSS Excited Component scale. Initial results from the trial are expected in the second quarter. Anesiva Inc., of South San Francisco

ArQule Inc., of Woburn, Mass., completed dose-escalation in its Phase I trial of ARQ 197, an oral small-molecule inhibitor of the c-Met receptor tyrosine kinase, and identified the optimal dose, when given orally two weeks out of three, at 120 mg twice daily. The company plans to explore a continuous dosing schedule prior to starting Phase II testing in the second quarter. ArQule also reported that it completed patient enrollment in three Phase II trials with ARQ 501, a first-generation

Clinic Roundup

Aida Pharmaceuticals Inc., of Hangzhou, China, has received approval from the State Food and Drug Administration of China to begin Phase II clinical trials of the genetic cancer treatment Rh-Apo2L, the Category A biopharmaceutical currently in development phase by the Company's subsidiary Shanghai Qiaer Biotechnology Co., Ltd. of Shanghai. The Phase II trials will analyze the effect of Rh-Apo2L on two types of tumors chosen from the following cancers: advanced inert lymphoma, malignant melanoma

BioMarin Pharmaceutical Inc., of Novato, Calif., said the first patient has been treated in the second, company-sponsored Phase II study with oral 6R-BH4 for symptomatic peripheral arterial disease. Commonly known as tetrahydrobiopterin, 6R-BH4 is an essential enzyme cofactor that is involved in the production of nitric oxide, a molecule that has been shown in clinical studies to play a key role throughout the cardiovascular system, including regulation of endothelial function. The company