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Patient enrollment for Phase 2B clinical study of Oramed Pharmaceuticals' ORMD-0801 completed

Oramed Pharmaceuticals Inc. announced today the completion of patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801.

20 Jan 2010

Merck’s initiation of EMD 1201081-cetuximab combination Phase 2 trial triggers €3.0M milestone payment

Idera Pharmaceuticals, Inc., today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon initiation of a Phase 2 trial by Merck KGaA of EMD 1201081, a novel agonist of Toll-like Receptor 9 (TLR9), in combination with cetuximab (Erbitux®) in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

20 Jan 2010

Preliminary data from Phase 1 study of Sangamo BioSciences' SB-728-T announced

Sangamo BioSciences, Inc. announced today that preliminary data from the University of Pennsylvania investigator sponsored Phase 1 safety study of Sangamo's zinc finger nuclease (ZFN) based product, SB-728-T, for HIV/AIDS were presented on Friday, January 15, 2010 at the Keystone Symposium Session "HIV Biology and Pathogenesis."

20 Jan 2010

CytoDyn commences enrollment in Cytolin clinical trial

Following approval of the Institutional Review Board, CytoDyn, Inc. has discharged its duty to register a clinical trial of Cytolin®, the Company’s lead product, with the government’s website at www.clinicaltrials.gov, ID NCT01048372. The public has online access to this federal database, which describes the key elements of clinical trials and their status.

19 Jan 2010

DURECT commences dosing in its POSIDUR Phase III clinical trial

DURECT Corporation announced today that it has begun dosing patients in its U.S. pivotal Phase III clinical trial to evaluate POSIDUR™ (SABER™-Bupivacaine), an investigational drug, for the treatment of post-surgical pain. The pivotal trial, referred to as BESST (Bupivacaine Effectiveness and Safety in SABER Trial), is an international, multi-center, randomized, double-blind, controlled trial evaluating the safety, efficacy, effectiveness, and pharmacokinetics of POSIDUR in patients undergoing general surgical procedures.

19 Jan 2010

Circassia commences Phase II trials of its T-cell vaccines against house dust mite and cat allergies

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that it has initiated phase II clinical trials of its T-cell vaccines targeting house dust mite and cat allergies. With the start of these studies, and the ongoing trial of Circassia's ragweed allergy (hay fever) T-cell vaccine, the company now has three clinical development programmes in phase II.

19 Jan 2010

PCI Biotech AS completes second dose group in phase I/II study of Amphinex

PCI Biotech AS ( PCIB.OL) reported today that it has completed the successful treatment of the second dose group in the phase I/II study of its proprietary photosensitiser Amphinex® used in combination with the cytotoxic agent bleomycin in cancer patients.

19 Jan 2010

Enrollment of Phase 2 portion of Cempra Pharmaceuticals' Phase 2/3 clinical trial of TAKSTA completed

Cempra Pharmaceuticals today announced completion of enrollment of the Phase 2 portion of its Phase 2/3 clinical trial of TAKSTA (sodium fusidate; CEM-102) for the treatment of acute bacterial skin and skin structure infections.

19 Jan 2010

New neuroprotective drug trial for people with traumatic brain injuries

A clinical trial of a new neuroprotective drug for people with traumatic brain injuries will be offered to patients seen in UC Davis Medical Center's level-1 trauma center, through an $8 million grant funded by the Congressionally Directed Medical Research Program of the U.S. Department of Defense.

18 Jan 2010

AVIR Green Hills Biotechnology commences deltaFLU Phase II study

AVIR Green Hills Biotechnology, the innovative biotech company based in Vienna, has started the New Year by embarking on the first clinical phase II study for the seasonal vaccine deltaFLU. The study will be carried out at the Medical University of Vienna. With this step, AVIR Green Hills has set yet another important milestone in the development of effective and modern influenza vaccines.

18 Jan 2010

Treatment for chronic hepatitis C with pegylated-interferon and ribavirin proves effective

The current standard treatment for chronic hepatitis C with pegylated-interferon (PEG-IFN) and ribavirin is effective in approximately 50%-60% of patients, so that a substantial proportion of patients remain unresponsive.

18 Jan 2010

Results from Bionovo's phase 1B clinical trial of Bezielle published

Bionovo, Inc. announced today the publication of their results from its phase 1B clinical trial of Bezielle (BZL101) for metastatic breast cancer. The results of the study are available online in Breast Cancer Research and Treatment and demonstrate that Bezielle continues to be safe and well tolerated with clinical evidence of anticancer activity in a heavily pretreated population of women diagnosed with metastatic breast cancer.

17 Jan 2010

Emisphere Technologies: Novo Nordisk initiates first Phase I clinical trial of GLP-1

Emisphere Technologies, Inc. today announced that Novo Nordisk has initiated its first Phase I clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2 million payment to Emisphere, whose proprietary Eligen® Technology is used in the formulation of NN9924.

13 Jan 2010

New clinical study: CeNeRx BioPharma's CXB722 has potential as novel anxiolytic

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today reported that a new clinical study shows that its investigational compound CXB722 has potential as a novel anxiolytic, demonstrating a significant effect on both endocrine and cardiovascular biomarkers associated with stress.

13 Jan 2010

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

Drug Trial News

Patient enrollment for Phase 2B clinical study of Oramed Pharmaceuticals' ORMD-0801 completed

Merck’s initiation of EMD 1201081-cetuximab combination Phase 2 trial triggers €3.0M milestone payment

Preliminary data from Phase 1 study of Sangamo BioSciences' SB-728-T announced

CytoDyn commences enrollment in Cytolin clinical trial

DURECT commences dosing in its POSIDUR Phase III clinical trial

Circassia commences Phase II trials of its T-cell vaccines against house dust mite and cat allergies

PCI Biotech AS completes second dose group in phase I/II study of Amphinex

Enrollment of Phase 2 portion of Cempra Pharmaceuticals' Phase 2/3 clinical trial of TAKSTA completed

New neuroprotective drug trial for people with traumatic brain injuries

AVIR Green Hills Biotechnology commences deltaFLU Phase II study

Treatment for chronic hepatitis C with pegylated-interferon and ribavirin proves effective

Results from Bionovo's phase 1B clinical trial of Bezielle published

Emisphere Technologies: Novo Nordisk initiates first Phase I clinical trial of GLP-1

New clinical study: CeNeRx BioPharma's CXB722 has potential as novel anxiolytic

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

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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