Aastrom Biosciences Inc., of Ann Arbor, Mich., enrolled its first patients in a Phase IIb trial of ixCELL-DCM to assess safety and efficacy of ixmyelocel-T in advanced heart failure that is caused by ischemic dilated cardiomyopathy. The randomized, double-blind, placebo-controlled trial will enroll 108 patients at about 30 sites in the U.S. to receive ixymyelocel-T through a catheter. The primary endpoint will be the average number of events per patient, over a 12-month period. Aragon

Ariad Pharmaceuticals Inc., of Cambridge, Mass., said in the first 12 weeks since commercial launch of Iclusig (ponatinib) in the U.S. (through March 2013), there were more than 225 unique prescribers of Iclusig and nearly 200 unique accounts using Iclusig. More than 325 patients in the U.S. are now being treated with Iclusig obtained commercially based on physicians' prescriptions. The company said it expects that adoption of Iclusig among community physicians will continue to increase as the

Trimel Pharmaceuticals Corp., of Toronto, amended its preliminary short form prospectus with details related to changes to a previously announced proposed marketed offering of stock units consisting of one share of common stock and a warrant to purchase one half share. A syndicate of underwriters led by RBC Capital Markets will carry out the offering, which no longer includes the sale of any common shares by Eugene Melnyk. All units will be sold by the company, and the company will receive all

Shape Pharmaceuticals Inc. is not aiming to reshape the industry. The Cambridge, Mass.-based biotech has the more modest goal of advancing its single asset, topical histone deacetylase (HDAC) inhibitor SHP-141, in cutaneous T-cell lymphoma (CTCL) and, potentially, other inflammatory skin conditions. The company's name refers to the molecule itself, suberohydroxamic acid phenyl ester, or SHAPE, discovered by co-founders James Bradner, the prolific Dana Farber Cancer Institute researcher, and

Close to 20,000 attendees from more than 60 countries are expected to converge on Washington for the American Association for Cancer Research's (AACR) annual meeting this weekend and early next week, for science, clinical advances and, the meeting's organizers hope, perhaps even some politics. Jose Baselga, physician-in-chief at Memorial Sloan-Kettering Cancer Center and the chairman of the program committee for the 2013 annual meeting, said in a recorded greeting that the data being presented

An appellate court's ruling Wednesday against Pfizer Inc. paints the way forward for more racketeering claims against drugmakers who plead guilty to criminal off-label promotion charges as part of a government settlement. In separate opinions handed down Wednesday, the U.S. Court of Appeals for the First Circuit upheld a $142 million racketeering verdict against Pfizer and revived two similar civil cases filed by third-party payers asserting violations of the Racketeer Influenced and Corrupt

Privately held BIND Therapeutics Inc. didn't let the dust settle after a potential $180.5 million deal with Amgen Inc. in January. Wednesday morning, the Cambridge, Mass.-based biotech revealed that Pfizer Inc. sealed an even bigger global collaboration to develop and commercialize multiple Accurins in small-molecule targeted therapies. The Pfizer deal goes a step further than the Amgen agreement, which involved the development of a nanotechnology-based therapeutic for solid tumors, with up

The new round of Phase II studies funded by Aquinox Pharmaceuticals Inc.'s $18 million Series C financing should let the company bolster data gained already in chronic obstructive pulmonary disease (COPD), gain data in bladder pain syndrome/interstitial cystitis (BPS/IC) and then make decisions on whether to partner at the pivotal-trial stage. AQX-1125, the firm's lead candidate from the SH2-containing inositol-5'-phosphatase (SHIP1) program, has undergone a pair of Phase II studies testing its

If current dreams of an AIDS-free generation are to be realized, it will be necessary to develop an effective vaccine against HIV. And such a vaccine will need to induce a broadly neutralizing antibody. About 1 in five HIV-infected individuals ultimately develops such antibodies – not that it does them any good. "These antibodies have unusual traits," Barton Haynes, of Duke University, told BioWorld Today, and developing those traits takes time, and a long journey from the naïve germline

Raising fees is not the way to reduce a growing backlog of requests for continued examination (RCEs), several patent attorneys told the Patent and Trademark Office (PTO) Wednesday. Rather than punishing patent applicants for filing RCEs, the PTO needs to recognize that the requests are a part of the overall patent process and grant them a higher priority. As it is now, drugmakers and other patent filers can wait years for their RCEs to be handled, Courtenay Brinckerhoff, a patent attorney with

Biogen Idec Inc., of Weston, Mass., said it completed the purchase of Dublin, Ireland-based Elan Corp. plc's interest in Tysabri (natalizumab) and has gained full strategic, commercial and decision-making rights to the multiple sclerosis drug. The firms disclosed the $3.25 billion deal, which includes contingent payments, in February. (See BioWorld Today, Feb. 7, 2013.) DARA BioSciences Inc., of Raleigh, N.C., said it signed a deal with Prime Therapeutics Specialty Pharmacy LLC for

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, reported results of a Phase II study in acromegaly patients showing that Somatoprim, its somatostatin analogue, demonstrated a dose-dependent effect on lowering excess growth hormone in treatment-naïve patients. No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature. The trial was designed to test single-ascending doses of Somatoprim in up to 20 patients. Cellular Biomedicine

Shares in ChronTech Pharma AB plunged as much as 40 percent during trading Tuesday on news that ChronVac-C, the company's therapeutic DNA vaccine for treating hepatitis C virus (HCV) infection, failed to attain efficacy in an interim analysis of data from a Phase II trial. Its partner, electroporation device developer Inovio Pharmaceuticals Inc., of Blue Bell, Pa., sustained collateral damage. Its stock (NYSE:INO) was off 8 percent Tuesday, closing at 52 cents, down 5 cents. Comprising a plasmid

Teams led by scientists from the Scripps Research Institute and the Seattle Biomedical Research Institute reported last week that they have engineered and identified, respectively, parts of HIV that can strongly stimulate naïve B cells to produce the sorts of antibodies that can ultimately become broadly effective against HIV – a step toward the development of an HIV vaccine that has long eluded researchers. They published their findings in the March 28, 2013, advance online issue of Science

Being in the right space at the right time gave CytoDyn Inc. a shot in the pipeline that may have advanced its HIV/AIDS R&D program five years. The shot came in the form of PRO 140, an injectable monoclonal antibody (mAb) the small biotech picked up last October from Progenics Pharmaceuticals Inc. in a deal worth $10 million plus potential royalties. When the Portland, Ore.-based company acquired the mAb, the FDA already had granted it fast-track status and the National Institutes of Health

A new collaboration between Ra Pharmaceuticals Inc. and Merck & Co. Inc. will focus on harnessing the therapeutic power of peptide drugs through a platform technology that offers candidates pre-designed for cell permeability and oral bioavailability. Under the agreement, Ra will apply its Extreme Diversity technology to create cyclomimetic candidates for Merck's protein targets in a number of therapeutic areas. Ra is eligible for up to $200 million in payments under the agreement, including up

Privately held Revance Therapeutics Inc. raised $33 million in a Series E financing and converted $71 million in convertible debt into Series E preferred stock, aiming to complete U.S. Phase III trials for lead compound RT001, a physician-applied topical botulinum toxin type A (BoNTA), in the lead indication of lateral canthal lines, better known as crow's feet. The financing included both new and existing institutional investors, including Essex Woodlands, NovaQuest Pharma Opportunities Fund