for comfort during the biotech's Monday evening conference call, particularly after a series of analyses from a Phase II trial of cabozantinib (XL184) presented over the weekend at the American Society of Clinical Oncology's (ASCO) 2011 annual meeting sent shares tumbling 20.2 percent...The South San Francisco-based firm raised $165 million a few months later to push cabozantinib through clinical trials. (See BioWorld Today, Dec. 6, 2010, and March 11, 2011.) The results of initial trials seemed

Adeona Pharmaceuticals Inc., of Ann Arbor, Mich., announced that analyses of a clinical study evaluating reaZin, a gastroretentive, sustained-release, once-daily oral tablet formulated from zinc (150 mg) and amino acid cysteine (100 mg) for treatment of Alzheimer's disease, indicated that the older the reaZin treatment patient, the greater the amount of cognitive benefit compared to the placebo patients of the same age...The Fraunhofer USA Center for Molecular Biotechnology, iBio's research

Exelixis Inc., of South San Francisco, said data from a Phase I trial of cabozantinib in patients with advanced solid tumors in lymphoma were published in the Journal of Clinical Oncology...Oncothyreon Inc., of Seattle, started a Phase II portion of its ongoing Phase I/II trial of PX-866 in combination with the chimeric monoclonal antibody Erbitux (cetuximab) following successful completion of the Phase I dose-escalation portion

The primary endpoint for the dose-escalation portion will be adverse events using CTCAE criteria, while secondary endpoints will include clinical benefit, duration of response and time to progression

Akebia Therapeutics Inc., of Cincinnati, completed a 28-day, open-label, Phase IIa, dose-escalation trial of AKB-6548 in chronic kidney disease...The results were presented at the 2011 National Kidney Foundation Spring Clinical Meetings in Las Vegas, April 26-30

The single-arm, open-label, dose-escalation trial will evaluate doses from 25 mg to 400 mg daily for 14 days in a 21-day treatment cycle for safety, tolerability and pharmacokinetics...Data were presented at the American Association of Clinical Endocrinologists meeting in San Diego

The IFN-K-001 Phase I/II study is a double-blind, placebo-controlled, dose-escalation design testing four different IFNα-Kinoid dose levels...The company has decided to shelve its clinical development program in NCL for the time being

A third presentation highlighted the discovery of Debio 0932 (formerly CUDC-305), partnered with Jennerex Inc., of San Francisco, and Transgene, of Illkirch, France reported interim results from Phase I dose-escalation trials demonstrating that administration of JX-594 targets tumor vasculature, disrupting the blood supply to the solid tumors and contributing to destruction of the cancer...Phase I and II clinical trials in multiple cancer types have shown that JX-594, delivered directly into tumors

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., presented preclinical results for two clinical compounds...The company said findings supported the rationale for clinical testing of sapacitabine, for the treatment of acute myeloid leukemia in the elderly and for myelodysplastic syndromes and lung cancer, with inhibitors of DNA repair in both solid tumors and hematological malignancies

Following the dose-escalation phase, the trial calls for a stable-dose phase in which additional patients will receive the highest safe dose...In addition to safety, the trial will measure defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function

Overall, TH-302 has been studied in five clinical trials involving more than 400 patients with solid tumors as well as hematologic malignancies...In November 2010, Threshold reported that a Phase I/II three-arm, multicenter, dose-escalation and dose-expansion trial to determine safety, efficacy and pharmacokinetics of TH-302 in combination with gemcitabine, docetaxel or pemetrexed in patients with advanced solid tumors showed partial response or stable disease in 18 patients with advanced

The IND includes a Phase I/II dose escalation study to treat up to 40 subjects with myasthenia gravis with 12 weekly doses of BHT-3034 intramuscularly...This is the third compound developed with Bayhill's BHT-DNA platform to enter clinical trials

The approval will allow Poniard to include Chinese clinical sites in global registration trials within those disease settings...The dose-escalation trial will evaluate brentuximab vedotin, an antibody-drug conjugate, when administered sequentially or in combination with multi-agent, front-line chemotherapy regimens

The clinical study initially will involve 32 healthy volunteers and will focus on safety and tolerability of IQNLF, one component of IQ-DAA...CEQ508 is in a Phase Ib/IIa clinical development program for the treatment of familial adenomatous polyposis and has been granted orphan drug designation by the FDA...Trophos SA, of Marseille, France, completed its Phase I dose-escalation study of TRO40303, a mitochondria pore modulator aimed at reducing the cardiac reperfusion injury following a heart attack

The study, which appeared in the Journal of Clinical Oncology, found that Xgeva was noninferior to Zometa in delaying or preventing SREs. (See BioWorld Today, Nov. 22, 2010...Theratechnologies Inc., of Montreal, announced a new clinical program for muscle wasting in chronic obstructive pulmonary disease (COPD) using the company's lead compound, tesamorelin, a human growth hormone releasing factor analogue...Trevena Inc., of King of Prussia, Pa., initiated a Phase IIa clinical with its lead program

Harbor BioScience Inc., of San Diego, closed the clinical sites for its Phase I/IIa trial of Apoptone (HE3235) in castration-resistant prostate cancer...The primary endpoints are to assess the relative clinical responses to delafloxacin, linezolid and vancomycin and to assess the utility, variability and measurement techniques of several objective measures of clinical efficacy for use in future trials

A primary objective is to evaluate biomarkers in blood and archived tissue samples and their correlation with tivozanib clinical activity and/or drug-related toxicity...The open-label, dose-escalation study is being carried out in China

The open-label, multicenter clinical trial being run by the University of Southampton is evaluating a DNA vaccine to treat chronic myeloid leukemia and acute myeloid leukemia...It is the first clinical trial being conducted under Perseid's collaboration with Astellas, which is sponsoring the trial...The Phase I randomized, 65-patient, double-blind, placebo-controlled, dose escalation study will assess the safety, tolerability and pharmacokinetics of single ascending intravenous doses of Perseid's

The data were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium in San Francisco...Dose escalation will continue...Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco