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Encouraging early data from Bellicum Pharmaceuticals' Phase I/II study of BPX-101 for mCRPC

Bellicum Pharmaceuticals, Inc., a company developing therapeutic cancer vaccines, today announced the presentation of interim Phase I/II efficacy data for BPX-101, a novel dendritic cell vaccine for metastatic castrate resistant prostate cancer (mCRPC), in a Late Breaking poster at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 held in Washington, D.C.

19 Apr 2010

Phase II study: Hepatitis C patients receiving ANA598 bid plus SOC attain undetectable levels of virus

Anadys Pharmaceuticals, Inc. announced today that 72% of hepatitis C patients receiving ANA598 400 mg twice daily (bid) plus standard of care achieved undetectable levels of virus at week eight in an ongoing Phase II study, compared to 38% of patients receiving placebo plus SOC.

19 Apr 2010

Stallergenes' US phase III clinical trial of Oralair achieves primary endpoint

Stallergenes S.A. today announced the first results of a phase III clinical trial (VO61.08) conducted in the USA on its sublingual grass pollen immunotherapy tablet, Oralair(R).

19 Apr 2010

Amgen announces results from pivotal Phase 3 "408" trial of Vectibix

Amgen today announced detailed results from a new biomarker analysis of the pivotal Phase 3 "408" trial of Vectibix® (panitumumab) plus best supportive care compared to BSC alone. The analysis used massively parallel, next-generation sequencing technology to investigate whether mutations in nine genes known to be mutated in colorectal cancer, including the previously unanalyzed exon 3 mutation of the KRAS gene, are predictive of response to Vectibix in metastatic colorectal cancer.

19 Apr 2010

Results of BATTLE Trial presented at AACR 2010

Lung cancer is the number one cause of cancer death in men and women, but huge randomized trials of thousands of patients have either failed completely or shown negligible survival differences.

19 Apr 2010

Results from Phase 2 study of BOTOX in IOAB patients presented at Anniversary EAU Congress

Treatment options for idiopathic OAB patients not adequately managed by anticholinergic therapy are limited; either highly invasive, expensive or of limited efficacy. BOTOX® (onabotulinumtoxinA) may provide a minimally invasive effective treatment. Professor Chris Chapple and his group conducted the first large, double-blind, placebo-controlled, dose ranging study to systematically asses the benefit/risk balance of the use of BOTOX® in IOAB across a wide range of doses.

19 Apr 2010

G1 HCV patients having fast antiviral response to TVR with PEG-IFN and RBV can be cured in 24 weeks

24 weeks of treatment could be sufficient to cure between 93 and 100% of treatment-na-ve chronic hepatitis C virus (HCV) genotype 1 (G1) infected patients if they have a fast antiviral response to Telaprevir (TVR) with Peginterferon (PEG-IFN) and Ribavirin (RBV), according to new research presented today at the International Liver Congress 2010, the Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria.

17 Apr 2010

Ocera Therapeutics presents data on prevalence of neurocognitive impairment in cirrhotic patients

Ocera Therapeutics, Inc. presented an analysis of the prevalence of neurocognitive impairment in ambulatory cirrhotic patients. The data came from the screening period of the ASTUTE Study, an ongoing Phase 2b study evaluating the safety and efficacy of AST-120 (spherical carbon adsorbent) in the treatment of mild hepatic encephalopathy (MHE). The poster was presented yesterday at the annual meeting of the European Association for the Study of Liver (EASL) in Vienna, Austria. Efficacy and safety data from the ASTUTE study are expected in the summer of 2010.

17 Apr 2010

Multinational phase II study: GS-9450 can reduce markers of liver damage in patients with NASH

Results from a multinational phase II study presented today at the International Liver CongressTM 2010 have shown that treatment with the caspase inhibitor GS-9450 can reduce markers of liver damage in patients with non-alcoholic steatohepatitis (NASH - the most serious form of non-alcoholic liver disease) as demonstrated by reduced levels of alanine and aspartate aminotransferases, hepatic enzymes that indicate cell damage.

17 Apr 2010

New data on Cladribine Tablets presented at AAN annual meeting

EMD Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that new data providing further understanding on Cladribine Tablets as a potential new therapeutic option for relapsing forms of multiple sclerosis were presented at the 62nd Annual Meeting of the American Academy of Neurology.

17 Apr 2010

Tikcro Technologies reports net loss of $1.8M for fourth-quarter 2009

Tikcro Technologies Ltd. today reported results for the fourth quarter and year ended December 31, 2009.

17 Apr 2010

Knopp Neurosciences to initiate Phase 3 studies of KNS-760704 in AL

In an invited presentation today before the annual meeting of the American Academy of Neurology, Knopp Neurosciences Inc. described further encouraging trends observed in a previously reported Phase 2 study of KNS-760704 (dexpramipexole) in ALS.

17 Apr 2010

RegeneRx Biopharmaceuticals proposes common stock public offering

RegeneRx Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration in cardiovascular diseases, central nervous system injuries, ophthalmic indications and dermal wounds, announced today that it intends to offer units consisting of shares of its common stock and warrants to purchase shares of its common stock in a public offering.

17 Apr 2010

Repligen expects total revenue of $21.0M for fiscal year 2010

Repligen Corporation today announced preliminary financial results for fiscal year 2010 which ended March 31, 2010. Total revenue for the year is expected to be $21.0 million, including $10.3 million of bioprocessing product revenue and $10.7 million of royalty and other revenue. Research and development expenses are expected to be between $13.8-$14.2 million and selling, general and administrative expenses between $6.8-$7.2 million.

16 Apr 2010

VisEn Medical expands FMT imaging platform

VisEn Medical Inc., a leader in fluorescence imaging solutions from research through medicine, announced today that it has expanded its leading FMT imaging platform with an FMT™ Multi-Species Imaging Module, to extend FMT imaging and related applications into larger preclinical animal models. VisEn also announced that it will be presenting new study results from its recently-launched Cat B 750 FAST™ and Annexin-Vivo™ fluorescence imaging agents at the AACR 101st Annual Meeting.

16 Apr 2010

Results of study comparing REMICADE to azathioprine for Crohn's disease published

Findings published today in The New England Journal of Medicine from a first-of-its-kind comparator trial evaluating the anti-tumor necrosis factor (TNF)-alpha biologic treatment REMICADE (infliximab) in the treatment of moderately to severely active Crohn's disease in patients who were naive to immunomodulator and biologic therapy, showed that a significantly greater proportion of patients receiving REMICADE achieved steroid-free remission and mucosal healing compared with patients receiving azathioprine.

16 Apr 2010

InterMune reports Phase 1b MAD study results of RTV-boosted danoprevir in HCV patients at 45th EASL

InterMune, Inc. today announced results of all three cohorts from a 15-day Phase 1b multiple-ascending-dose (MAD) study of low doses of danoprevir (also known as RG7227 and ITMN-191) boosted by low-dose ritonavir (RTV) in patients chronically infected with hepatitis C virus (HCV) genotype-1.

16 Apr 2010

Findings strengthen promise of SCYNEXIS' SCY-635 for HCV treatment

Drug discovery company SCYNEXIS, Inc. today presented data supporting an impressive resistance profile for SCY-635—a novel, oral cyclophilin inhibitor being studied for the treatment of hepatitis C virus (HCV) infection. In the study, SCYNEXIS demonstrated that the hepatitis C virus required multiple mutations across two separate proteins in order to establish resistance to SCY-635. The majority of HCV drugs on the market and in development require only one targeted viral mutation to establish resistance.

16 Apr 2010

Promising pharmacokinetic data from Idenix Pharmaceuticals' Phase I study of IDX320 for HCV

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported promising in vitro data for IDX320, an HCV protease inhibitor, demonstrating potent and selective antiviral activity in multiple genotypes, or strains, of the virus.

16 Apr 2010

Data from Phase 2 clinical trials of Hematide/peginesatide presented at NKF Annual Meeting

Affymax, Inc. and Takeda Global Research & Development Center, Inc., U.S., today announced data from several post hoc analyses of Phase 2 clinical trials that evaluated Hematide/peginesatide in dialysis patients with anemia in chronic kidney disease. The data provide hypotheses for further investigation of this agent in anemia management in this patient population.

16 Apr 2010

Drug Trial News

Encouraging early data from Bellicum Pharmaceuticals' Phase I/II study of BPX-101 for mCRPC

Phase II study: Hepatitis C patients receiving ANA598 bid plus SOC attain undetectable levels of virus

Stallergenes' US phase III clinical trial of Oralair achieves primary endpoint

Amgen announces results from pivotal Phase 3 "408" trial of Vectibix

Results of BATTLE Trial presented at AACR 2010

Results from Phase 2 study of BOTOX in IOAB patients presented at Anniversary EAU Congress

G1 HCV patients having fast antiviral response to TVR with PEG-IFN and RBV can be cured in 24 weeks

Ocera Therapeutics presents data on prevalence of neurocognitive impairment in cirrhotic patients

Multinational phase II study: GS-9450 can reduce markers of liver damage in patients with NASH

New data on Cladribine Tablets presented at AAN annual meeting

Tikcro Technologies reports net loss of $1.8M for fourth-quarter 2009

Knopp Neurosciences to initiate Phase 3 studies of KNS-760704 in AL

RegeneRx Biopharmaceuticals proposes common stock public offering

Repligen expects total revenue of $21.0M for fiscal year 2010

VisEn Medical expands FMT imaging platform

Results of study comparing REMICADE to azathioprine for Crohn's disease published

InterMune reports Phase 1b MAD study results of RTV-boosted danoprevir in HCV patients at 45th EASL

Findings strengthen promise of SCYNEXIS' SCY-635 for HCV treatment

Promising pharmacokinetic data from Idenix Pharmaceuticals' Phase I study of IDX320 for HCV

Data from Phase 2 clinical trials of Hematide/peginesatide presented at NKF Annual Meeting

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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