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Ambit Biosciences presents data evaluating FLT3 inhibitor in AML at the 51st ASH meeting

Ambit Biosciences Corporation announced today that there will be multiple presentations evaluating AC220, a novel second generation FLT3 inhibitor, in AML at the 51st American Society of Hematology Annual Meeting (ASH) to be held in New Orleans, LA ,December 5-8, 2009. An oral presentation will highlight results from an ongoing clinical Phase I monotherapy safety study in adults with acute myeloid leukemia (AML).

25 Nov 2009

EMEA grants orphan drug status for LFB Biotechnologies' recombinant anti-CD20 monoclonal antibody

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the EMEA’s Committee for Orphan Medicinal Products (COMP) was handed down on last October 7th.

25 Nov 2009

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Ipsen today announced the initiation of an international, multi-center, controlled, randomized Phase II clinical trial to evaluate the safety and efficacy of BN83495, its investigational first-in-class steroid sulfatase (STS) inhibitor, in advanced endometrial cancer.

25 Nov 2009

Positive efficacy data from Phase 2 study of AEZS-108 announced

AEterna Zentaris Inc. (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with advanced or recurrent endometrial cancer.

25 Nov 2009

OmniComm Systems chosen as Beardsworth's preferred EDC provider

OmniComm Systems, Inc., one of the fastest growing companies in the EDC marketplace, today announced that Beardsworth, a full service contract research organization (CRO) who specializes in difficult therapeutic areas, has selected OmniComm's TrialMaster EDC solution for conducting a Phase II vaccine study.

24 Nov 2009

Ohr Pharmaceutical to develop OHR/AVR118 for cachexia treatment

Ohr Pharmaceutical Inc. is developing OHR/AVR118 for treatment of cachexia based on technology acquired earlier this year from Advanced Viral Research Corp. OHR/AVR118 has shown excellent therapeutic efficacy and safety in human clinical trials in over 100 patients with applications for cachexia in Cancer and AIDS patients, as well as Rheumatoid Arthritis.

24 Nov 2009

CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

CytRx Corporation, a biopharmaceutical company, today announced plans to initiate a multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a treatment for patients with advanced soft tissue sarcomas who have failed surgery and radiation. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body.

24 Nov 2009

Positive data from Æterna Zentaris' Phase 2 targeted cytotoxic peptide conjugate study

Æterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with advanced or recurrent endometrial cancer.

24 Nov 2009

StemCells commences patient recruitment for a Phase I clinical trial of HuCNS-SC in PMD

StemCells, Inc. announced today that it has commenced patient recruitment for a Phase I clinical trial designed to test the safety and preliminary efficacy of its HuCNS-SC® purified human neural stem cells in Pelizaeus-Merzbacher Disease (PMD), a neurological disorder that primarily afflicts children. The study is being conducted at the University of California, San Francisco (UCSF) Children’s Hospital, one of the leading medical centers in the United States for neonatology, pediatric neurology and neurosurgery.

24 Nov 2009

Proteon Therapeutics commences PRT-201 Phase 1/2 clinical study in hemodialysis patients

Proteon Therapeutics, Inc., has initiated a Phase 1/2 human clinical study of its lead product, PRT-201, in end-stage renal disease (ESRD) patients undergoing surgery for arteriovenous graft (AVG) creation. The AVG study represents Proteon's second human clinical study in hemodialysis patients, previously announcing the initiation of a Phase 1/2 study of PRT-201 in ESRD patients undergoing surgery for arteriovenous fistula (AVF) creation earlier this year.

23 Nov 2009

Top-line data from Lexicon Pharmaceuticals' LX1031 Phase 2 study for IBS to be presented

Lexicon Pharmaceuticals, Inc., announced today that top-line data from its Phase 2 clinical study with LX1031 in patients with non-constipating irritable bowel syndrome (IBS) will be presented at GASTRO 2009 in London this week. Results from the study, which showed a significant improvement in IBS symptoms, will be presented by Dr. Philip M. Brown, Lexicon's senior vice president of clinical development, on November 25, 2009 at 2:30 pm local time at the session entitled, "Therapeutic insights in functional digestive disorders."

23 Nov 2009

Acucela to present data on its ACU-4429 visual cycle modulator for dry AMD

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that data for the company’s novel visual cycle modulator, ACU-4429, a potential oral treatment for dry age-related macular degeneration (dry AMD), will be featured at the 8th International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) being held in Rome, Italy from December 3 to 6, 2009.

23 Nov 2009

Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, today announced positive interim results from a randomized Phase 2 clinical trial evaluating the vascular disrupting agent (VDA) plinabulin (NPI-2358) in combination with standard chemotherapy (docetaxel) in patients with advanced non-small cell lung cancer (NSCLC).

23 Nov 2009

Phase IIb/III clinical trial results of CINQUIL for pediatric EoE announced

Ception Therapeutics, Inc., a privately held biopharmaceutical company, and Cephalon, Inc. today announced results from a Phase IIb/III clinical trial for CINQUIL(TM) (reslizumab) as a treatment for pediatric eosinophilic esophagitis (EoE). The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms.

23 Nov 2009

Phase 1 data of ARIAD Pharmaceuticals' pan-BCR-ABL inhibitor to be presented at the ASH meeting

ARIAD Pharmaceuticals, Inc. today announced that the Company and collaborating investigators from five major oncology research centers in the United States will present data from a Phase 1 clinical trial of ARIAD’s investigational, multi-targeted kinase inhibitor and pan-BCR-ABL inhibitor, AP24534, at the 51st Annual Meeting of the American Society of Hematology (ASH) being held in New Orleans, Louisiana, December 5-8, 2009.

23 Nov 2009

Provectus Pharmaceuticals announces Phase 1 interim study data of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that initial one year overall survival data from the first 20 subjects in the current Phase 2 trial showed comparable trends to Phase 1 survival data.

23 Nov 2009

Human Genome Sciences commences patient dosing in its HGS1029 inhibitor trial

Human Genome Sciences, Inc. and Aegera Therapeutics, Inc. today announced that HGS has initiated dosing in a Phase 1 clinical trial to evaluate the safety and tolerability of its lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors.

23 Nov 2009

Raptor Pharmaceutical announces Phase 2b results of DR Cysteamine trial

Raptor Pharmaceutical Corp., today announced results from a Phase 2b clinical trial of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis"). The trial, conducted at the University of California, San Diego ("UCSD") General Clinical Research Center, evaluated safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in nine cystinosis patients.

23 Nov 2009

Raptor Pharmaceutical announces results of NGX426 clinical trial

Raptor Pharmaceutical Corp. today announced the presentation of clinical trial data on NGX426, the Company's orally administered, non-opioid, AMPA/kainate receptor antagonist, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, held on November 20-21 in San Francisco.

23 Nov 2009

Enrollment for ongoing phase 2b trial of RG7128 announced

Pharmasset, Inc. announced today that the enrollment of Cohort 2, led by its partner Roche, will continue for the remaining 300 genotype 1 and 4 patients in the ongoing phase 2b trial of RG7128, a first-in-class nucleoside analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

23 Nov 2009

Drug Trial News

Ambit Biosciences presents data evaluating FLT3 inhibitor in AML at the 51st ASH meeting

EMEA grants orphan drug status for LFB Biotechnologies' recombinant anti-CD20 monoclonal antibody

Initiation of Phase II clinical trial to evaluate the efficacy of BN83495 announced

Positive efficacy data from Phase 2 study of AEZS-108 announced

OmniComm Systems chosen as Beardsworth's preferred EDC provider

Ohr Pharmaceutical to develop OHR/AVR118 for cachexia treatment

CytRx to initiate a multinational Phase 2 clinical trial of its doxorubicin prodrug

Positive data from Æterna Zentaris' Phase 2 targeted cytotoxic peptide conjugate study

StemCells commences patient recruitment for a Phase I clinical trial of HuCNS-SC in PMD

Proteon Therapeutics commences PRT-201 Phase 1/2 clinical study in hemodialysis patients

Top-line data from Lexicon Pharmaceuticals' LX1031 Phase 2 study for IBS to be presented

Acucela to present data on its ACU-4429 visual cycle modulator for dry AMD

Positive interim results from Nereus Pharmaceuticals' plinabulin VDA study for advanced NSCLC

Phase IIb/III clinical trial results of CINQUIL for pediatric EoE announced

Phase 1 data of ARIAD Pharmaceuticals' pan-BCR-ABL inhibitor to be presented at the ASH meeting

Provectus Pharmaceuticals announces Phase 1 interim study data of PV-10 for metastatic melanoma

Human Genome Sciences commences patient dosing in its HGS1029 inhibitor trial

Raptor Pharmaceutical announces Phase 2b results of DR Cysteamine trial

Raptor Pharmaceutical announces results of NGX426 clinical trial

Enrollment for ongoing phase 2b trial of RG7128 announced

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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