Bionor Pharma ASA, of Oslo, Norway, reported results from a multinational Phase IIb, placebo-controlled multicenter study of Vacc-4x, a therapeutic HIV vaccine based on four synthetic slightly modified peptide sequences from conserved parts of the P24 capsid protein of the HIV virus...In July, the FDA approved the company's investigational new drug application for QLT091001, whose clinical trial application also has been cleared by the U.K. Medicines and Healthcare Products Regulatory Agency...The

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase I study of ACE-536, a ligand trap designed to increase red blood cells and hemoglobin by inhibiting member of the TGF-beta superfamily involved in late stages of erythropoiesis...Under the firms' 2010 deal, Otsuka will contract with Acucela for early clinical development in exchange for an opt-in right to co-develop and co-promote the compound in the U.S...Ascendis Pharma A/S, of Copenhagen, Denmark, said a Phase II study of ACP-001

The study, initiated in April, enrolled 52 patients at clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon to evaluate the safety and tolerability of HQK-1001...Nektar Therapeutics Inc., of San Francisco, said its breast cancer candidate, NKTR-102, showed a high response rate and strong clinical benefit in a Phase II trial in metastatic breast cancer, even in subsets of patients with a poor prognosis...Tranzyme Pharma Inc., of Research Triangle Park, N.C., presented data from a Phase II

In patients who achieved clinical success but had recurrence, the mean degree of contracture had yet to return to pre-treatment levels after three years...marketing rights in Europe and Tokyo-based Asahi Kasei Pharma Corp...Nektar will present results from a Phase I single-ascending dose trial at the American Academy of Pain Management's Annual Clinical Meeting later this month

After reaching clinical proof of concept, it can seek the bigger markets...The specialty pharma and diagnostics company entered the deal with the Swiss firm in May. (See BioWorld Today, May 26, 2011.)

BioAlliance Pharma SA, of Paris, reported that its liver cancer product, Livatag, showed increased survival in a Phase II trial...DelMar Pharma Ltd., of Vancouver, British Columbia, said the FDA cleared its investigational new drug application to start clinical testing of VAL-083, a bifunctional alkylating agent, in refractory glioblastoma multiforme (GBM...Noxxon Pharma AG, of Berlin, said it started a Phase I trial of NOX-H94, a Spiegelmer designed to treat anemia of chronic disease by targeting the

Our lead clinical candidate, a novel antibiotic that targets fatty acid metabolism of staphylococcal strains like MRSA that are very commonly associated with lethal infections in man is not only more potent than other anti-staphylococcal antibiotics, but it uses a new mechanism of action...Paris-based FAB Pharma also has a Phase I FabI program for MRSA...The closing was supported by a consortium of informal investors and follows a first close of €4 million in January.

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

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.

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

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

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