Basilea Pharmaceutica Ltd., of Basel, Switzerland, said partner Astellas Pharma Inc., of Tokyo, submitted a new drug application to the FDA seeking approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. The drug was granted as a qualified infectious disease product (QIDP) earlier this year for invasive mucormycosis and received QIDP status last year for invasive aspergillosis.
Domainex Ltd., of Cambridge, UK, said its lead compound demonstrated a more potent effect in a key model of chronic obstructive pulmonary disease than either PDE4 inhibitor Daxas (roflumilast, Forest Laboratories Inc.) or a p38 inhibitor. The Domainex compound showed more than twice the effect of the comparator drugs in reducing the cigarette smoke-induced influx of inflammatory cells, particularly neutrophils, into the lung. The company also won a £1.4 million (US$2.4 million) Biomedical Catalyst Award to support further development of phase I studies. In parallel with ongoing partnering talks, Domainex plans to seek funding to explore the utility of its approach in other inflammatory diseases and to move the program through proof of concept.
Lightlake Therapeutics Inc., of London, signed an agreement with a commercial contract manufacturer that will produce its early stage naloxone-based opioid overdose reversal treatment and has sufficient capacity to carry it through commercialization, the company said.
Myos Corp., of Cedar Knolls, N.J. received approval to list on Nasdaq at market open on July 10, under its existing ticker symbol, MYOS. The bionutrition and biotherapeutics company hopes the change will raise its visibility among investors and enhance the liquidity of its common stock.
Nuvilex Inc., of Silver Spring, Md., said it completed preparation to start preclinical studies next month testing the effectiveness of its pancreatic cancer treatment in slowing down the accumulation of ascites fluid. Ascites fluid accumulation in the abdomen is usually associated with the development of advanced pancreatic and other abdominal cancers. Translational Drug Development LLC will conduct the study, and Austrianova Singapore is providing the live cells, to be encapsulated using Nuvilex's Cell-in-a-Box technology, which are capable of converting cancer prodrug ifosfamide, along with the prodrug itself.
Opko Health Inc., of Miami, said the European Committee for Orphan Medicinal Products recommended approval of orphan designation for the company's long-acting version of clotting factor VIIa for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors of factor VIII or factor IX and congenital factor VII deficiency. The product obtained orphan status in the U.S. earlier this year. Opko said it anticipates initiating a phase IIa trial with its intravenous formulation in hemophilia patients late this year.
Oxygen Biotherapeutics Inc., of Morrisville, N.C., disclosed three recent review articles examining the use of levosimendan, including publication in Heart, Lung and Vessels highlighting the clinical profile of the drug in acute heart failure. Data published in Current Pharmaceutical Design describe levosimendan's triple mechanism of action: sensitizing calcium channels in cardiac myofilaments; opening the ATP-sensitive potassium channels in smooth muscle cells; and opening the ATP-sensitive potassium channels of mitochondria of cardiac cells. A third publication, in the Journal of Clinical Medicine Research, provided an overview of the drug in a range of critical care situations in which cardiac failure is a concern, including cardiac surgery, cardiogenic shock, sepsis, renal dysfunction and renal failure. Oxygen is preparing to start a phase III study in the U.S. in the third quarter to test levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome.
PTC Therapeutics Inc., of South Plainfield, N.J., said it started a reimbursed expanded access program (EAP) intended to make Translarna (ataluren) available to patients before commercial availability in certain countries. Where mechanisms exist and in accordance with local regulations, PTC said it will make Translarna available to nonsense mutation Duchenne muscular dystrophy patients through funded EAP programs. Funded named patient programs already have been authorized in Turkey and Spain, and the French National Agency for Medicines and Health Products Safety Wednesday granted a temporary authorization for use.
Soligenix Inc., of Princeton, said the combination of Rivax and Velothrax induces a protective immunity to both ricin toxin and anthrax toxin exposure. When administered as single vaccines, each induced antibodies that were capable of neutralizing the toxin from which the vaccine had been derived, with Velothrax inducing neutralizing antibodies against anthrax toxin and Rivax inducing antibodies against ricin toxin. When combined, the dual vaccine induced antibodies that were reactive against both toxins, and those neutralizing antibodies were detected until at least 200 days after the immunization regimens. Consequently, the combined vaccination provided protection to exposure to both ricin toxin and anthrax toxin that persisted for at least six months after two vaccinations, suggesting that long-term immunity upon simultaneous vaccination can be achieved. The studies were performed under the aegis of a $9.4 million cooperative grant from the National Institute of Allergy and Infectious Diseases.
Summit Corp. plc, of Oxford, UK, gained an FDA qualified infectious disease product designation for its phase II antibiotic SMT19969 for the treatment of C. difficile infection. The designation includes eligibility for priority review and fast track status and, if SMT19969 receives FDA approval, a five-year extension of market exclusivity.
Sunesis Pharmaceuticals Inc., of South San Francisco, reported that the Pediatric Committee of the EMA issued a positive opinion on the company's pediatric investigation plan for Qinprezo (vosaroxin), its experimental quinolone derivative. Sunesis is testing the drug in a pivotal trial measuring its benefit for patients with first relapsed or refractory acute myeloid leukemia.
Zogenix Inc., of San Diego, succeeded in overturning a Massachusetts restriction on access to the company's extended-release opioid, Zohydro ER (hydrocodone). Despite the victory, the company's bigger threat lies in the FDA's July 9 decision to grant priority review to an abuse-deterrent hydrocodone formulation developed by Stamford, Conn.-based Purdue Pharma LP. If Purdue's pill is approved, the FDA has suggested it might remove Zohydro ER from the market. (See BioWorld Today, April 9, 2014.)