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Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Spectrum Pharmaceuticals today announced that the second of two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target. The two trials enrolled more than 1600 patients with non-muscle invasive bladder cancer. As per the collaboration agreement with Allergan, a $1.5 million milestone payment will be paid to Spectrum Pharmaceuticals.

13 Jan 2010

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Spherix Inc., an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the completion of patient enrollment in its global Phase 3 clinical trial NEET (70971-004), which is evaluating the safety and efficacy of D-tagatose as an oral treatment for Type 2 diabetes mellitus.

12 Jan 2010

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

VION PHARMACEUTICALS, INC. announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.

12 Jan 2010

Preliminary results from Nektar Therapeutics' NKTR-102 Phase 2 study in platinum-resistant ovarian cancer

Nektar Therapeutics today announced preliminary results from the first stage of a two-stage Phase 2 clinical study evaluating NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients enrolled with platinum-resistant disease were evaluable for the primary endpoint of overall response rate using Gynecologic Cancer InterGroup (GCIG) criteria, i.e., a combination of response by tumor imaging

12 Jan 2010

Phase I clinical trial of XRX-001 for yellow fever initiated

Xcellerex, Inc. today announced that it has initiated a Phase I clinical trial of XRX-001, a novel, prophylactic vaccine against yellow fever, a tropical virus disease that is often fatal.

12 Jan 2010

Cytheris commences enrollment in its recombinant human Interleukin-7 INSPIRE 2 program for HIV

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in INSPIRE 2, a Phase IIa clinical program evaluating the company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non Responders (INR) after at least 12 months of highly active anti-retroviral therapy (HAART).

12 Jan 2010

HGS reports commercialization of late-stage products for systemic lupus and chronic hepatitis C

Human Genome Sciences, Inc. today will announce its priority goals for 2010 and report on the Company’s increasing momentum toward commercialization of late-stage products for systemic lupus and chronic hepatitis C in a presentation by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 28th Annual JPMorgan Healthcare Conference in San Francisco.

12 Jan 2010

Pfizer/Medivation's AD drug Dimebon may garner peak year sales of $1.5 billion

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, if Pfizer/Medivation's Dimebon shows efficacy in two ongoing clinical trials in moderate to severe Alzheimer's disease that is equivalent to the impressive clinical trial data it has already shown to date in mild to moderate patients, these positive data would promote the use of Dimebon throughout the course of the disease.

12 Jan 2010

Salt Lake City research center joins international drug trial program for painful menstrual cramps

A leading clinical research center in Salt Lake City has joined an international trial program to test an experimental new drug designed to treat painful menstrual cramps, or dysmenorrhea, a condition that affects between 45 and 90 percent of women of childbearing age in the United States. Although not life threatening, dysmenorrhea can be debilitating and psychologically taxing and is one of the leading causes of absenteeism from work and school.

12 Jan 2010

CEL-SCI completes validation of its GMP manufacturing facility

CEL-SCI Corporation, a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today it has completed the validation of all critical utilities and manufacturing equipment at its GMP manufacturing facility in Maryland.

12 Jan 2010

NicOx, TOPIGEN Pharmaceuticals terminate TPI 1020 collaboration

NicOx S.A. today announced that NicOx and TOPIGEN Pharmaceuticals Inc. have mutually terminated their collaboration for TPI 1020. This decision was made as a result of the acquisition of TOPIGEN by Pharmaxis announced yesterday.

12 Jan 2010

Pfizer commences recruitment for Phase I clinical trial of SA3Ag vaccine

Inhibitex, Inc. today announced that its collaborator, Pfizer, Inc., has initiated patient recruitment for 408-patient, randomized, double-blind Phase I clinical trial to evaluate the safety, tolerability, and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus (S. aureus) vaccine (SA3Ag) in healthy adults.

12 Jan 2010

4SC commences treatment in its resminostat Phase II trial for HL

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today announced the treatment of the first patient in a Phase II study evaluating resminostat (4SC-201), an oral pan-histone-deacetylase (HDAC) inhibitor in relapsed or refractory Hodgkin's Lymphoma (HL) patients.

12 Jan 2010

Idenix Pharmaceuticals announces significant progress in HCV development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced significant progress in three HCV programs

12 Jan 2010

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine. The Company announced in May 2009 that the efficacy portion of its Phase 3 FREEDOM-301 clinical study of LEVADEX met all four primary endpoints. The Company had previously anticipated initiating a second pivotal efficacy study in the first quarter of 2010.

12 Jan 2010

YM BioSciences announces results of cancer antibody-radionuclide conjugate development collaboration

YM BioSciences Inc. today announced results of a collaboration with researchers at the University of Toronto for the development of highly potent antibody-radionuclide conjugates for use in the treatment of cancer. The approach has successfully concluded its first series of proof-of-principle experiments establishing promise for future development and application.

12 Jan 2010

Pfizer commences SBI-087 Phase 2 clinical trial for RA

Trubion Pharmaceuticals, Inc. today announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).

12 Jan 2010

Antares Pharma, Population Council report positive Phase 2 results for novel NES/E2 contraceptive gel

Antares Pharma, Inc. and the Population Council today announced successful results from a dose-finding Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. Based on this successful data, the two parties continue to expect to partner with a worldwide or regional pharmaceutical company in order to commercialize this novel contraceptive gel.

12 Jan 2010

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, was created using KemPharm’s proprietary Ligand Activated Therapy (LAT) prodrug approach.

12 Jan 2010

Interim results from Phase I clinical trials utilizing PLX-PAD for treatment of CLI reported

Pluristem Therapeutics Inc. today announced interim results from their Phase I clinical trials utilizing their placenta derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

12 Jan 2010

Drug Trial News

Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

Preliminary results from Nektar Therapeutics' NKTR-102 Phase 2 study in platinum-resistant ovarian cancer

Phase I clinical trial of XRX-001 for yellow fever initiated

Cytheris commences enrollment in its recombinant human Interleukin-7 INSPIRE 2 program for HIV

HGS reports commercialization of late-stage products for systemic lupus and chronic hepatitis C

Pfizer/Medivation's AD drug Dimebon may garner peak year sales of $1.5 billion

Salt Lake City research center joins international drug trial program for painful menstrual cramps

CEL-SCI completes validation of its GMP manufacturing facility

NicOx, TOPIGEN Pharmaceuticals terminate TPI 1020 collaboration

Pfizer commences recruitment for Phase I clinical trial of SA3Ag vaccine

4SC commences treatment in its resminostat Phase II trial for HL

Idenix Pharmaceuticals announces significant progress in HCV development programs

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

YM BioSciences announces results of cancer antibody-radionuclide conjugate development collaboration

Pfizer commences SBI-087 Phase 2 clinical trial for RA

Antares Pharma, Population Council report positive Phase 2 results for novel NES/E2 contraceptive gel

Positive results from KemPharm's KP106 Phase 1 clinical trial for ADHD

Interim results from Phase I clinical trials utilizing PLX-PAD for treatment of CLI reported

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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