LONDON – The future development of a new class of antidepressants has edged closer, with the discovery of a molecular pathway that is fundamental to the development of depression. In depression, high levels of stress hormones such as glucocorticoids are linked to a reduced rate by which new brain cells develop – a process called neurogenesis. Researchers based at the Institute of Psychiatry in London have identified a molecule that, when blocked, halts the decrease in neurogenesis that
By Sharon Kingman | BioWorld International | Wednesday, May 8, 2013
GlaxoSmithKline plc's initiative on data transparency took a decisive step forward Tuesday as the company switched on the website that will act as the point of access to its vast repositories of clinical data and named the independent review panel who will control that access. Accredited researchers will be able to access the data (via https://clinicalstudydata.gsk.com/) only after gaining approval for their research proposals from the four-person panel. They also would have to commit to
By Cormac Sheridan | BioWorld International | Wednesday, May 8, 2013
LONDON – Redx Pharma Ltd. has unveiled a shift in strategy away from a sole focus on internally generated compounds, with the in-licensing of an early stage oncology program from Canadian biotech Pharmascience Inc. At the same time Redx announced it has put in place funding for a diversification into anti-infectives and is opening a new unit on the site of AstraZeneca plc's largest R&D facility at Alderley Park, Cheshire, UK. That will fill some of the vacuum that is about to be generated by
By Nuala Moran | BioWorld International | Wednesday, May 8, 2013
Less than a year after licensing constipation drug elobixibat from Swedish biotech Albireo AB, Ferring Pharmaceuticals SA initiated enrollment in two Phase III trials of the investigational compound in chronic idiopathic constipation (CIC). The randomized, double-blind studies, Echo 1 and Echo 2, will be conducted at nearly 200 sites worldwide and will enroll approximately 1,700 patients, aiming to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a
By Marie Powers | BioWorld International | Wednesday, May 8, 2013
SAN FRANCISCO – When AiCuris GmbH, of Wuppertal, Germany, analyzed the market for human cytomegalovirus (HCMV) therapies, it found a market with high medical need, neglected by big pharma, featuring a variety of disease manifestations. The market had also fallen under the radar of payers, all resulting in low competition, with the potential for high prices and low marketing and sales costs, according to Helga Rubsamen-Schaeff, AiCuris CEO. In her presentation for a panel featuring the nominees
By Catherine Shaffer | BioWorld International | Wednesday, May 8, 2013
Addex Therapeutics SA, of Geneva, disclosed positive preclinical data for its GABAB receptor-positive allosteric modulator in a rodent model of chronic alcohol dependence. The Addex alcoholism candidate, ADX71441, demonstrated robust and dose-dependent suppression of alcohol intake in animals lasting 24 hours. ADX71441 is an oral small molecule, with potential for once-daily dosing. In other news, Addex said dipraglurant demonstrated dose-dependent mGlu5 receptor occupancy in a nonhuman primate
Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. AmorChem, of Montreal, and InflammatorRx Inc., of Quebec City, said they launched a research collaboration
Aileron Therapeutics Inc., of Cambridge, Mass., completed the first-in-human study of its lead stapled peptide drug, ALRN-5281. The long-acting growth hormone-releasing hormone agonist is in development for orphan endocrine disorders such as adult growth hormone deficiency and HIV lipodystrophy and broader indications in metabolic and endocrine disease. The initial Phase I evaluated the safety and tolerability of single ascending doses of ALRN-5281 administered by subcutaneous injection in
Baxter International Inc., of Deerfield, Ill., said a Phase III study testing immunoglobulin did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. Results, however, showed a positive, numerical difference in the change from baseline vs. placebo in cognition in a subgroup analysis, though the study was not powered to show statistical significance among subgroups. Based on those data, Baxter
Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer. The product previously received orphan status in the U.S. and Japan. Lenvatinib is in Phase III testing in several indications, including thyroid cancer. In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting
Array BioPharma Inc.'s Phase III trial planned for this summer in recurrent low-grade serous ovarian cancer (LGSOC) with its Novartis AG-partnered MEK inhibitor is one of a handful of late-stage studies expected to roll out this year. "We're looking at five pivotal trials, all starting this year, across our two MEKs," said Ron Squarer, Array's CEO. "There could be more, based on data that's emerging at [the American Society of Clinical Oncology (ASCO) meeting] this year." Called MILO (MEK
By Randy Osborne | BioWorld Today | Wednesday, May 8, 2013
Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported its first revenue from cancer drug Iclusig (ponatinib), which was approved in December for use in adults with chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. Net sales totaled $6.4 million for the quarter ending March 31. Ariad posted a net loss for the quarter of $64.7 million, or 36 cents per share, a narrower loss
Astellas Pharma Inc., of Tokyo, and Drais Pharmaceuticals Inc., of Bridgewater, N.J., will repeat for the third time a spinout maneuver that has been successful with two other programs in the past. The companies partnered to develop and commercialize Astellas's compound ASP7035, a vasopressin V2 receptor selective agonist in development for nocturia, by means of a licensing arrangement to a new virtual company, Tacurion Pharma Inc., to be managed by the Drais executive team. InterWest Partners
By Catherine Shaffer | BioWorld Today | Wednesday, May 8, 2013
Success rates doubled for cancer drugs that entered clinical trials in the early 1990s and those that entered the clinic a decade later, even as the number of such compounds increased by 50 percent over the period, according to a new analysis by the Tufts Center for the Study of Drug Development (CSDD). Clinical success rates – the percentage of investigational compounds that eventually obtain FDA approval – for cancer therapeutics rose from 9.9 percent for drugs that entered the clinic in the
By Marie Powers | BioWorld Today | Wednesday, May 8, 2013
Generic drugmakers appear to be winning in the showdown with biologics makers over state legislation that would limit the automatic substitution of future biosimilars. Colorado, Florida and Indiana are the latest states to shoot down a bill that would require notification and recordkeeping if a pharmacy substitutes a biosimilar for the prescribed biologic. The legislation was modeled on principles the Biotechnology Industry Organization (BIO) has identified as core safeguards for patients
By Mari Serebrov | BioWorld Today | Wednesday, May 8, 2013
The immune system is able to kick out many viral invaders after a few days to weeks. But others, from herpes to hepatitis C, can come to be in a permanent standoff with the immune system, controlled but not eliminated altogether. In chronic viral infection, CD8 "killer" T cells enter a state that has been called "exhausted." Such cells no longer produce cytokines to any appreciable effect, and many scientists thought they were incapable of dividing. But a team from the Swiss Vaccine Research
By Anette Breindl | BioWorld Today | Wednesday, May 8, 2013
After voting 17-1 that data from a National Institutes of Health (NIH)-sponsored animal study were sufficient to approve Amgen Inc.'s Neupogen as a treatment for radiation sickness, two FDA advisory committees told the agency that the data should be applied to all drugs in the same class. With the Biomedical Advanced Research and Development Authority (BARDA) looking to procure a hefty supply of a granulocyte colony-stimulating factor (G-CSF) such as Neupogen for emergency use in case of a
By Mari Serebrov | BioWorld Today | Tuesday, May 7, 2013
Cel-Sci Corp., of Vienna, Va., reported findings from an efficacy study in a second animal model of rheumatoid arthritis (RA) using its LEAPS technology. The study evaluated the LEAPS vaccine's effect in the Proteoglycan-induced arthritis (PGIA) model of RA with a dominant T helper 1 (Th1) cytokine profile. Disease severity, measured on the basis of the Arthritis Index and histopathology, was significantly suppressed in mice treated with the LEAPS vaccine compared to controls. The reduction in
LONDON – The future development of a new class of antidepressants has edged closer, with the discovery of a molecular pathway that is fundamental to the development of depression. In depression, high levels of stress hormones such as glucocorticoids are linked to a reduced rate by which new brain cells develop – a process called neurogenesis. Researchers based at the Institute of Psychiatry in London have identified a molecule that, when blocked, halts the decrease in neurogenesis that