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Profectus BioSciences commences GENEVAX IL-12 phase 1 study for HIV

Profectus BioSciences, a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, and the AIDS Clinical Trials Group announced today the initiation of a phase 1 study of Profectus' multi-antigen HIV plasmid DNA vaccine administered with various doses of GENEVAX™ interleukin-12 pDNA adjuvant and delivered using the electroporation based TriGrid™delivery system developed by Ichor Medical Systems.

6 Jan 2011

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

Sanofi-aventis and its wholly-owned subsidiary, BiPar Sciences, today announced that The New England Journal of Medicine published the final phase II data for the investigational drug iniparib demonstrating significant clinical benefit in women with metastatic triple negative breast cancer when iniparib was administered in combination with chemotherapy agents gemcitabine/carboplatin.

6 Jan 2011

Positive topline results from ZGN-433 Phase 1b study in obesity patients

Zafgen, a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced positive topline results from its Phase 1b study of ZGN-433, a methionine aminopeptidase 2 inhibitor, for the treatment of severe obesity.

6 Jan 2011

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced that patient enrollment was recently completed in the company's Phase 1/2 clinical trial of ISV-303, a novel compound being developed to reduce the pain and inflammation associated with ocular surgery.

6 Jan 2011

DARA BioSciences provides additional details of DB959 Phase I study for Type 2 Diabetes

DARA BioSciences, provided additional details from the recently completed Phase I clinical study for DB959, its PPAR delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes.

6 Jan 2011

Carbylan completes enrollment in COR1.0 feasibility trial of Hydros and Hydros TA in knee osteoarthritis

Carbylan BioSurgery, Inc. announced today the completion of patient enrollment in their double-blinded, multi-center COR1.0 feasibility trial to evaluate the safety and effectiveness of two products - Hydros and Hydros TA Joint Therapies - in patients with osteoarthritis of the knee. Hydros and Hydros TA are next generation viscosupplement and viscosupplement/steroid combination products.

5 Jan 2011

SuperGen initiates enrollment in first human trial of SGI-110 in MDS and AML

SuperGen, Inc. today announced that it has enrolled the first patient in its first in human study of SGI-110, a second-generation hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML).

5 Jan 2011

Alnylam presents ALN-VSP Phase I trial results for liver cancer

Alnylam Pharmaceuticals, a leading RNAi therapeutics company, today presented new clinical data from its ALN-VSP Phase I liver cancer trial in a presentation at the Dana-Farber Cancer Institute in Boston. Results from molecular analysis of human biopsy samples showed achievement of pharmacologically relevant siRNA drug levels in tissues.

5 Jan 2011

Vaccinex receives FDA clearance to initiate VX15/2503 Phase 1 clinical trial in advanced solid tumors

Vaccinex, Inc. announced today that it has received clearance from FDA and will initiate a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of therapeutic antibody candidate VX15/2503 in cancer patients with advanced solid tumors.

5 Jan 2011

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.

5 Jan 2011

FDA lifts clinical hold on Hemispherx's Alferon LDO Phase II study for influenza prevention

Hemispherx Biopharma, Inc. announced today that the Food and Drug Administration (FDA) has lifted a clinical hold on its Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon® LDO [oral interferon alfa-n3 (human leukocyte derived)] for the prevention and treatment of influenza.

5 Jan 2011

Pico-Tesla announces expansion of Magneceutical Phase III trail for Parkinson's disease

Pico-Tesla, The Magneceutical Company, announced that it has expanded its ongoing Phase III pivotal clinical trial by adding three Principal Investigators, including two university-affiliated clinicians: one in Denver; and one in Tampa.

5 Jan 2011

Anadys begins ANA598 Phase IIb study for hepatitis C

Anadys Pharmaceuticals, Inc. announced today that it has initiated the planned Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin. The protocol for the study has been cleared by the United States Food and Drug Administration and Health Canada.

4 Jan 2011

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).

4 Jan 2011

Isis commences ISIS-EIF4ERx Phase 2 studies in non-small cell lung cancer and prostate cancer

Isis Pharmaceuticals, Inc. announced the initiation of two Phase 2 studies of ISIS-EIF4ERx in patients with non-small cell lung cancer and prostate cancer. These studies are part of Isis' broad Phase 2 development program designed to evaluate ISIS-EIF4ERx in multiple types of cancer. ISIS-EIF4ERx targets eukaryotic initiation factor-4E (eIF-4E), a traditionally "undruggable" target that is thought to promote tumor growth and metastasis in many cancers.

4 Jan 2011

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

Repros Therapeutics Inc. today reported it has received Institutional Review Board (IRB) approval to commence the Phase IIb study of Androxal® in men with secondary hypogonadism. The Company has submitted the protocol for FDA comment and plans to begin enrolling subjects in January. Depending on the rate of subject enrollment, Repros hopes to have the study completed before the end of 2011.

3 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.

30 Dec 2010

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced today that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva® for patients with Non-Small Cell Lung Cancer (NSCLC).

30 Dec 2010

Drug Trial News

Profectus BioSciences commences GENEVAX IL-12 phase 1 study for HIV

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

Positive topline results from ZGN-433 Phase 1b study in obesity patients

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

DARA BioSciences provides additional details of DB959 Phase I study for Type 2 Diabetes

Carbylan completes enrollment in COR1.0 feasibility trial of Hydros and Hydros TA in knee osteoarthritis

SuperGen initiates enrollment in first human trial of SGI-110 in MDS and AML

Alnylam presents ALN-VSP Phase I trial results for liver cancer

Vaccinex receives FDA clearance to initiate VX15/2503 Phase 1 clinical trial in advanced solid tumors

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

FDA lifts clinical hold on Hemispherx's Alferon LDO Phase II study for influenza prevention

Pico-Tesla announces expansion of Magneceutical Phase III trail for Parkinson's disease

Anadys begins ANA598 Phase IIb study for hepatitis C

FDA approves ImmunoCellular Therapeutics IND amendment for ICT-107 Phase II clinical trial

Isis commences ISIS-EIF4ERx Phase 2 studies in non-small cell lung cancer and prostate cancer

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

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