Clavis Pharma ASA, of Oslo, Norway, said it will expand its pivotal Phase III trial, dubbed CLAVELA, testing elacytarabine in patients with late-stage acute myeloid leukemia in order to improve the chances of success...Medistem Inc., of San Diego, filed a response to the FDA's clinical hold for its Phase I trial application seeking to treat 10 patients with critical limb ischemia who have no options but amputation with the company's universal donor endometrial regenerative cells (ERCs...Since the

Clavis Pharma ASA, of Oslo, Norway, said that interim efficacy data from a Phase II trial showed promising clinical activity from a combination treatment of elacytarabine and idarubicin in patients with acute myeloid lymphoma who have failed cytarabine-containing, first-course chemotherapy...Verona Pharma plc, of London, said that its bronchodilator RPL554 showed sustained action in a Phase II trial in patients with asthma

That fact could prove a draw to big pharma firms when Pulmatrix starts looking for a partner...In COPD, the company will need some big pharma muscle...Shares of Lorus (TSX:LOR) fell C6 cents, or 17 percent, to close Monday at C30 cents.

Action Pharma A/S, of Arhus, Denmark, said that it has completed the last visit of its last patient in a Phase IIb study of AP214 for prevention of kidney injury in patients undergoing cardiac surgery...It will now proceed with compiling data from its eight clinical sites in the U.S

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.

Novartis attributed its interest in Sorbent to CLP1001's promising clinical data...ZS Pharma also is developing an oral product for hyperkalemic patients based on its ZirSi crystal structure technology...Oragenics Inc., of Tampa, Fla., amended its line of credit with the Koski Family Limited Partnership, increasing the total amount from $5 million to $7 million.

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

Inc. (See BioWorld Today, Dec. 16, 2010.) Hedley said the company anticipates starting its first ALK inhibitor clinical trial in mid-2012...OncoSec said it intends to use proceeds from the offering for further development of its ElectroOncology therapies to treat cancers, for clinical studies and for general corporate purposes.

Assistant Managing Editor Proving that big pharma firms aren't the only ones interested in the orphan disease space, venture investors are getting behind 2010 start-up Ultragenyx Pharmaceutical Inc...Funds will be used to prepare and submit a new drug application for lead product lomitapide in homozygous familial hypercholesterolemia (HoFh), complete clinical and nonclinical studies in HoFH, advance development of the drug in pediatric and adolescent patients and for general corporate purposes

The competitive field is wide open for an as-needed, "pill in the pocket" therapy for PSVT that patients can self-administer without the need to go to a clinical setting...Cordex intends to begin prospective, double-blind, placebo-controlled and randomized trials with ATPace in approximately 200 patients to demonstrate clinical safety and efficacy to support a new drug application filing of ATPace for the treatment of PSVT in emergency room patients...Quintiles will make a seven-figure investment

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

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.)