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Translational Medicine patient's own immune system after surgery and chemoradiation treatments to hunt and destroy remaining brain tumor cancer cells. The primary endpoint of the study is overall survival, and secondary endpoints include progression-free survival, immune response (T cells), and safety. > Epizyme (www.epizyme.com) com- menced a Phase I study of EPZ-5676, a small molecule inhibitor of DOT1L, a his- tone methyltransferase that is critical to the development of a specific type of acute leukemia defined by rearrangement of the MLL gene (MLL-r leukemia). The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of escalating doses of EPZ-5676 and will also provide a prelimi- nary assessment of efficacy in a cohort of patients with MLL-r leukemia. Approxi- mately 40 patients will be accrued. Chronic Neuropathic Pain > Zalicus (www.zalicus.com) initiated the first of two Phase IIa studies with Z160, its oral, state-dependent, selective N-type calcium channel blocker for the treatment of chronic neuropathic pain indications. The study will enroll subjects with chronic neu- ropathic pain associated with Lumbosacral Radiculopathy (LSR). Z160 is designed to selectively modulate only those neurons transmitting pain, specifically neurons that are undergoing high-frequency firing. The six-week, double-blind, multicenter, randomized, placebo-controlled study is expected to enroll up to approximately 140 subjects. The primary objective of the trial is to evaluate Z160 efficacy compared to placebo in reducing pain in subjects with LSR as measured by change in aver- age daily pain score from baseline to week six of treatment based on an 11-point pain intensity numeral rating scale. Parkinson's Disease Psychosis > Acadia Pharmaceuticals (www. acadia-pharm.com) completed enrollment for its Phase III trial with pimavanserin in patients with Parkinson's disease psychosis (PDP). Pimavanserin is a small molecule that acts selectively as an antagonist/inverse ag- onist on serotonin 5-HT2A receptors. It can be taken orally as a tablet once-a-day. The study is multicenter, double-blind, placebo-controlled and designed to evaluate the efficacy, tolerability, and safety of pima- vanserin as a treatment for patients with PDP. A total of 198 patients have been enrolled and were randomized on a one-to-one basis to receive either 40 mg of pimavanserin or placebo once-daily for six weeks. The pri- mary endpoint is antipsychotic efficacy as measured using nine items from the halluci- nations and delusions domains of the scale for the assessment of positive symptoms. Ricin Toxin Exposure > Soligenix (www.soligenix.com) pre- sented results of a Phase Ib trial of an aluminum hydroxide (alum) adjuvanted formulation of RiVax™, its vaccine against ricin toxin exposure. The results indicate that alum adjuvanted RiVax is safe, well tolerated, and induces greater ricin neu- tralizing antibody levels in humans than adjuvant-free RiVax. The trial was designed to evaluate the long-term safety and immunogenicity of escalating doses of the vaccine up to one year after a primary vaccination, in which the vaccine was administered by intra- muscular injections at zero, six weeks, and six months in doses of 10 and 100 micro- grams. At peak antibody titers determined two weeks after the third vaccination, all of the subjects developed neutralizing an- tibodies against ricin toxin. All subjects in the 10 microgram dose group developed neutralizing antibodies with the alum formulation of RiVax com- pared to only one of five subjects in the 10 microgram group of the adjuvant-free vac- cine. For the 100 microgram dose vaccine, peak neutralizing titers were fourfold high- er than the adjuvant-free vaccine, with to- tal antibody titers (including all antibodies directed against the vaccine) 17-fold higher. Of all vaccine recipients of both the high dose and the low dose, 100% were seropositive at nine months after the first vaccination, with 60% remaining positive at one year. Q BD PureCoat ECM Mimetic Cultureware Chemically-synthesized, animal-free pre-coated cultureware. ™ Natural performance. Scientifically defined. Introducing BD PureCoat™ ECM Mimetic cultureware, the first animal-free synthetic surface to mimic natural extracellular matrix (ECM) functionality. Rationally designed, animal-free peptide immobilized on a proprietary surface, creates a highly consistent alternative to animal-derived ECM for hMSCs, keratinocytes, endothelial progenitor and other ECM-dependent cells. BD PureCoat ECM Mimetic cultureware is pre-coated, room temperature stable, cGMP compliant and available in a variety of formats, including T-flasks and multiwell plates. To learn how BD PureCoat ECM Mimetic cultureware can enable your defined serum-, xeno-, or animal-free cell culture environment, visit bdbiosciences.com/mimetic BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. © 2012 BD BD Biosciences Discovery Labware 296 Concord Road Billerica, MA, 01821 USA bdbiosciences.com Genetic Engineering & Biotechnology News | genengnews.com | October 1, 2012 | 63