Apceth GmbH, of Munich, Germany, received approval to conduct a clinical cancer trial with its genetically modified adult mesenchymal stem cells...Sunesis Pharmaceuticals Inc., of South San Francisco, said the independent data and safety monitoring board for the pivotal VALOR trial completed its latest period safety review and recommended that the study continue as planned without changes

The study, initiated in July 2012, enrolled a total of 77 patients in clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon...Oxigene Inc., of South San Francisco, said final results of FACT study (Fosbretabulin in Anaplastic Cancer of the Thyroid) a randomized controlled global trial in anaplastic thyroid cancer published in Thyroid, which suggested a survival benefit in patients who received Zybrestat and chemotherapy vs

Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

Exelixis Inc., of South San Francisco, started METEOR, a Phase III pivotal trial comparing cabozantinib to everolimus (Afinitor, Novartis) in patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor...Virttu Biologics Ltd., of Glasgow, Scotland, said an on-going clinical study in the U.S

Alios BioPharma Inc., of South San Francisco, began oral dosing of ALS-8176 in a Phase I trial...Sunesis Pharmaceuticals Inc., of South San Francisco, published a paper in the July 2013 issue of Expert Opinion on Pharmacotherapy detailing the advantages of voxaroxin over anthracycline therapy

The San Francisco-based company said proceeds, raised exclusively from existing shareholders and partner companies, will advance the clinical development of Pexa-Vec in HCC and in the follow-on indication of refractory colorectal cancer

Jennerex Biotherapeutics Inc., of San Francisco, and Transgene SA, of Strasbourg, France, said enrollment in the 120-patient TRAVERSE Phase IIb study testing Pexa-Vec (JX-594/TG6006, pexastimogene devacirepvec) for the treatment of advanced primary liver cancer in patients who failed prior therapy with Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer Ag) is complete...Rigel Pharmaceuticals Inc., of South San Francisco, said it is advancing three programs in development

The South San Francisco-based company has become the 12th biotech in the 2013 IPO class, and another dozen are filed and pending, signaling a definitive end to the long wait for markets to regain avid interest in new biotech opportunities following the market crash of 2008...The company's platform technology is designed to improve drug delivery into internal body cavities.

SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland...Sunovion Pharmaceuticals Inc., of Marlborough, Mass., will present 18 research posters on Latuda (lurasidone HCl), an atypical antipsychotic indicated

Worlund credits the investor interest to the science, which emerged from the University of California, San Francisco (UCSF), where academic co-founders Davide Ruggero and Kevan Shokat outlined the connections between disregulated translation and cancer...The money should carry the new company "for about three years-plus," Worlund said, long enough to get clinical proof of concept with a lead program

Jennerex Biotherapeutics Inc., of San Francisco, said data demonstrating the ability of its lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec) to induce functional anticancer immunity, both in patients with diverse solid tumor types and in animal models has been published in the May 15 issue of Science Translational Medicine...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable

These data led to Eleven's Phase Ib clinical study of EBI-005 in subjects with dry eye disease, with top-line data from the Phase Ib study expected in the second half of 2013...Portola Pharmaceuticals Inc., of South San Francisco, Calif., reported safety and efficacy data from a Phase II proof-of-concept study of PRT4445 of Eliquis (apixaban) in healthy volunteers

spun out in 2011, and Flexion Therapeutics Inc., of Woburn, Mass., founded by veterans of Eli Lilly and Co.'s Chorus division to advance abandoned early clinical programs through proof of concept. (See BioWorld Today, Feb. 1, 2010, and July 28, 2011.) The $15 million investment in Tacurion will support a Phase II proof-of-concept trial for the drug that should take 18 months to two years to complete...Portola Pharmaceuticals Inc., of South San Francisco, set the price range for its proposed initial

Coronado plans to use the proceeds to fund R&D, clinical trials and manufacture of supply as well as other corporate purposes...OxiGene Inc., of South San Francisco, entered agreements with institutional investors for a private placement of $5 million of zero coupon convertible preferred stock, convertible into approximately 1.38 million shares of common stock at a price of $3.63 apiece, and two series of warrants that may be exercised for up to approximately 2.76 million additional shares of

Exelixis Inc., of South San Francisco, presented additional information about the mechanism of action of cabozantinib with respect to activity against prostate cancer tumors metastasized to bone...The study was carried out to explore previous clinical findings with cabozantinib in castration-resistant prostate cancer patients with bone metastases showing a 67 percent rate of bone scan response and other clinical signs of effect

The company's "exceptional team" and its potential to obtain rapid clinical efficacy data were two attractive attributes, Rafaèle Tordjman, managing partner at Sofinnova Partners, told BioWorld Today...Cleave Biosciences Inc., of San Francisco, raised $10 million in an extension of its Series A financing from new investor New Enterprise Associates (NEA), bringing its Series A total to $54 million

Cytokinetics Inc., of South San Francisco, initiated a Phase I trial of CK-2127107 in healthy male volunteers...Tengion Inc., of Winston-Salem, N.C., said the firm's clinical trial application was accepted in Sweden to start a Phase I trial testing its Neo-Kidney Augment in up to five patients with advanced chronic kidney disease

Medgenics Inc., of San Francisco, said underwriters exercised an option to purchase stock in its recent public offering...The funds will be used to advance Theraclone's clinical programs and support its I-STAR technology platform.

Another $406 million could come in the form of clinical, regulatory and commercial milestones, and Enanta would be eligible for tiered, double-digit royalties and a U.S...newly commercial orphan drug developer Hyperion Therapeutics Inc., of South San Francisco...Net proceeds are expected to support clinical trial costs and acquisition of manufacturing equipment, leasehold improvements and general corporate purposes