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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

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

ZIOPHARM Oncology, Inc., announced today that the first patient has been dosed in a Phase I, single arm, dose escalation study at the Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the treatment of small cell lung cancer (SCLC) and other cancers.

29 Dec 2010

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery™ product candidate.

29 Dec 2010

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

CEL-SCI Corporation announced today that it has commenced its Phase III clinical trial for Multikine®, the Company's flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study.

29 Dec 2010

Merck confirms plans for developing vernakalant drug for atrial fibrillation

Cardiome Pharma Corp. today announced that it has been advised by its partner, Merck, that the current review of vernakalant is complete, and that Merck has informed Cardiome of its next steps in clinical development for vernakalant beginning in 2011.

29 Dec 2010

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).

28 Dec 2010

Intellect obtains pharmacokinetic data from OX1 Phase 1b trial for Alzheimer's disease

Intellect Neurosciences, Inc., a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has obtained a draft pharmacokinetic report from its completed Phase 1b trial for its lead Alzheimer's candidate, OX1. The Company previously reported on the safety aspects of the trial, which demonstrated that OX1 is safe and well tolerated at all dose levels tested.

28 Dec 2010

Myrexis initiates controlled two-arm Azixa Phase 2b clinical study in glioblastoma multiforme

EpiCept Corporation today reported that Myrexis, Inc. has initiated a controlled two-arm Phase 2b clinical study of Azixa™ as a front-line treatment for glioblastoma multiforme (GBM). Azixa™, a vascular disruption agent with potent anti-cancer activity, was discovered by EpiCept as part of its ASAP technology platform and licensed to Myrexis.

28 Dec 2010

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.

28 Dec 2010

Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Emergent BioSolutions today announced the initiation of a Phase I clinical trial for NuThraxTM, also known as AV7909, with the dosing of the first subject.

27 Dec 2010

Target enrollment reached in belinostat Phase 2 study in Carcinoma of Unknown Primary

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the target enrollment has been reached for the Phase 2 study of belinostat in Carcinoma of Unknown Primary (CUP).

23 Dec 2010

Pfizer's sublicensing of Tanaproget triggers $1 million upfront payment to Ligand

Ligand Pharmaceuticals Incorporated announced today that its partner Pfizer, Inc. has granted a sublicense to a multi-national pharmaceutical company for Tanaproget, also known as NSP-989. As a result, Ligand will receive an upfront payment of $1 million from Pfizer. Ligand is entitled to clinical and regulatory milestone payments from Pfizer as Tanaproget advances through the development process, as well as tiered royalties on net sales.

23 Dec 2010

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Clinical Data, Inc., today announced that Santen Pharmaceutical Co., Ltd., has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Clinical Data's highly selective adenosine A2A agonist, ATL313, for the indication of primary open angle glaucoma and ocular hypertension.

From Santen Pharmaceutical Co., Ltd. 23 Dec 2010

Myrexis commences Azixa controlled two-arm Phase 2b clinical study in GBM

Myrexis, Inc., a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced it has initiated a controlled two-arm Phase 2b clinical study of Azixa (verubulin) as a front-line treatment for glioblastoma multiforme (GBM).

23 Dec 2010

Medicago completes first part of H5N1 vaccine Phase II trial

Medicago, a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced that the last dose of vaccine has been administered completing the first part of the Company's Phase II human clinical trial with its H5N1 Avian Influenza vaccine.

23 Dec 2010

Gilead stops ARTEMIS-IPF ambrisentan Phase III clinical trial in idiopathic pulmonary fibrosis

Gilead Sciences, Inc. today announced it is stopping ARTEMIS-IPF, the company's ongoing Phase III clinical trial of ambrisentan in patients with idiopathic pulmonary fibrosis (IPF), due to lack of efficacy. This decision follows an interim analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC) and review of those data by Gilead, which did not show evidence of a treatment benefit in the group of patients randomized to receive ambrisentan.

23 Dec 2010

Drug Trial News

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

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

Merck confirms plans for developing vernakalant drug for atrial fibrillation

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Intellect obtains pharmacokinetic data from OX1 Phase 1b trial for Alzheimer's disease

Myrexis initiates controlled two-arm Azixa Phase 2b clinical study in glioblastoma multiforme

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Target enrollment reached in belinostat Phase 2 study in Carcinoma of Unknown Primary

Pfizer's sublicensing of Tanaproget triggers $1 million upfront payment to Ligand

Santen files IND for Clinical Data's ATL313 for primary open angle glaucoma and ocular hypertension

Myrexis commences Azixa controlled two-arm Phase 2b clinical study in GBM

Medicago completes first part of H5N1 vaccine Phase II trial

Gilead stops ARTEMIS-IPF ambrisentan Phase III clinical trial in idiopathic pulmonary fibrosis

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