Acacia Pharma Ltd., of Cambridge, UK, started a Phase II study of APD515, an oromucosal formulation of a currently marketed drug, in xerostomia (dry mouth) in advanced cancer patients...Threshold Pharmaceuticals Inc., of Redwood City, Calif., initiated a clinical trial of TH-302 in combination with bevacizumab (Avastin, Roche AG) in patients with recurrent high-grade astrocytoma including glioblastoma

The findings were based on Kohl's correspondence with six big pharma companies and an inquiry into URL Pharma Inc.'s pricing of its gout drug Colcrys (colchicine) and Avarin Pharmaceuticals Inc.'s pricing of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), the first approved treatment for pseudobulbar affect. (See BioWorld Today, June 3, 2011.) In a letter to the pharma companies, which included AstraZeneca plc and Eli Lilly and Co., Kohl asked why "Americans pay, on average

Horizon Pharma Inc., of Northbrook, Ill., set terms for its proposed initial public offering...The specialty pharma firm is aiming to sell 5.5 million shares priced between $10 and $12 each...Proceeds will be used for clinical trials and general purposes

The Swiss pharma firm's candidate uses a drug delivery technology from Cedar Knolls, N.J.-based Emisphere Technologies Inc...cardiac clinical trial, a European indication-for-use for the Celution system in treating nonoption chromic myocardial ischemia patients, Celution regulatory approvals in additional countries and a strategic partnership...Shares of Cytori (NASDAQ:CYTX) gained 1 cent Tuesday to close at $5.22.

For now the company's scientific founders, David Woodley and Mei Chen at USC, have just received a National Institutes of Health grant for a clinical study of the recombinant protein in epidermolysis bullosa patients...A.P. Pharma Inc., of Redwood City, Calif., entered a definitive agreement with new and existing investors to raise $24 million in a private placement of common stock and warrants...The company said the funds are an additional source of liquidity to fund its clinical development plans

Endotis Pharma, of Paris, enrolled the first patients in a Phase IIa trial of anticoagulant EP217609 and its specific antidote, avidin, to manage coagulation during open-heart surgery...Infinity Pharmaceuticals Inc., of Cambridge, Mass., said it is expanding its clinical program for IPI-926, an oral, small molecule designed to inhibit Smoothened, a component of the Hedgehog pathway

LifeCycle Pharma A/S, of Horsholm, Denmark, said lead candidate LCP-Tacro demonstrated noninferiority compared to Prograf (tacrolimus, Astellas Pharma Inc.) in a Phase III trial enrolling 326 stable kidney transplant recipients...Senesco Technologies Inc., of Bridgewater, N.J., said the FDA removed the clinical hold on the company's investigational new drug application for SNS01-T in multiple myeloma

Ambit Biosciences Corp., of San Diego, and partner Astellas Pharma Inc., of Tokyo, reported data from an interim analysis of a Phase II study of AC220, a selective FLT3 inhibitor, as a once-daily monotherapy in acute myeloid leukemia patients with FLT3-ITD activating mutations who have relapsed or are refractory to other treatments...Clinical response data was reported for 53 patients and showed a composite complete remission rate (CRc) of 45 percent, with the majority of CRc cases represented by

Although Oliver Fetzer, president and CEO of Cerulean Pharma Inc., said he thinks the existing regulatory framework is robust enough to evaluate the safety and efficacy of nanopharmaceuticals, he is encouraged by the thoughtful approach the FDA is taking in providing clarity for this innovative technology...A biotech on the leading edge of nanotechnology, Cerulean, of Cambridge, Mass., has been interacting with the FDA in bringing its nanopharmaceuticals into clinical development...The revision

The drug was previously included as part of a six-year option agreement with GlaxoSmithKline plc, but the big pharma passed on the compound in 2008...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 to garner mixed feedback at ASCO...Astellas Pharma Global Development Inc., of Deerfield, Ill., said AGS-1C4D4 reduced tumor formation and

It was a really big discovery and generated a lot of interest in big pharma," he added...Proceeds will allow the firm to advance product candidates in its portfolio toward clinical development...Proceeds are expected to help complete the ongoing 240-patient trial of DCVax-L for the treatment of glioblastoma multiforme and advance other programs in the pipeline.

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...Celgene Corp., of Summit, N.J., and Acceleron Pharma Inc., of Cambridge, Mass

We have a network of pharma experts who all told us, if it was their compound it would be given the green light to go into clinical development...We'll get clinical proof of concept and then think about it...The company said it will use the funds to complete Phase IIa studies with lead Smac mimetic drug candidate, TL32711, in solid tumors and to initiate clinical studies in hematological cancers.

That drug also is part of the large AstraZeneca collaboration, and the big pharma firm is positioning TC-5214 as an add-on therapy in MDD, which would pit it against Abilify (aripiprazole, Bristol-Myers Squibb Co...Proceeds will be used to fund clinical trials, working capital and other general corporate purposes. (See BioWorld Today, May 19, 2011.)

Based on those difficulties, in addition to the need to sharpen the toxicology profile and a potential requirement for an altered dosage, the companies opted to terminate clinical development of EVT 101...Pharma Two B, of Rehovot, Israel, said it is planning a Phase II study of combination therapy P2B001, in development to treat the early stages of Parkinson's disease

PolyMedix Inc., of Radnor, Pa., presented new clinical and preclinical data at the 21st Annual European Congress of Clinical Microbiology and Infectious Disease/27th Annual International Congress of Chemotherapy, in Milan, Italy, related to the safety and efficacy of its lead defensin-mimetic antibiotic, PMX-30063, that the company said reaffirmed that PMX-30063 does not cause nerve damage at the tested doses and indicated that interactions with ion channels are the underlying mechanism of the

Chimerix Inc., of Durham, N.C., presented clinical data at the International Conference on Antiviral Research in Sofia, Bulgaria, showing that the majority of immunocompromised patients with severe adenovirus infections who were treated with Chimerix's lead antiviral compound, CMX001, had a greater than 99 percent decrease in viral load compared to baseline after two weeks of therapy...The trials will enroll a total of 1,700 subjects at 72 clinical sites, and are expected to conclude in 2012

Meritage Pharma Inc., of San Diego, said a Phase IIb trial of oral budesonide suspension for eosinophilic esophagitis met its primary endpoin...Tranzyme Pharma Inc., of Research Triangle Park, N.C., will present results from a Phase II trial of TZP-102 in a poster session at Digestive Disease Week...Rapid response rates were achieved across various clinical response measures, including good/moderate EULAR response rates at weeks six and 12 (67.4 percent and 77.6 percent, respectively, vs. 27 percent

A.P. Pharma Inc., of Redwood City, Calif., will raise $4.5 million in convertible notes in a private placement deal with certain investors, including Tang Capital Partners...In other news, A.P. Pharma said it met with the FDA March 31 to discuss a complete response letter regarding its new drug application for APF530 for chemotherapy-induced nausea and vomiting...The discussion topics included dosing system, clarification of assays for manufacture and quality control, and a QT/metabolism clinical