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Dosing in First-in-Man Phase I study of 4SC AG's 4SC-203 commenced

4SC AG, a drug discovery and development company, today announced the start of dosing in a First-in-Man Phase I study in healthy volunteers evaluating 4SC-203, a novel multi-target kinase inhibitor, with particular specificity against selected kinases, including FMS-like tyrosine kinase 3 (FLT3), FLT3 mutants and vascular endothelial growth factor receptors (VEGF-R).

21 Jan 2010

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained positive results from a recently completed Phase 2 study of LX4211 in patients with type 2 diabetes mellitus. LX4211 is a once-per-day, orally-delivered, small molecule drug candidate that inhibits the sodium-dependent glucose transporter 2 (SGLT2), lowering the accumulation of glucose in the body and reducing caloric load.

20 Jan 2010

PROLOR Biotech's hGH-CTP Phase I study data to be presented at the BIO CEO & Investor Conference

PROLOR Biotech, Inc., today announced that final data from a randomized, dose-escalating Phase I clinical study of its longer-acting version of human growth hormone (hGH-CTP) will be featured in an oral presentation by PROLOR management at the 12th Annual BIO CEO & Investor Conference to be held at the Waldorf-Astoria Hotel in New York City on February 8-9, 2010.

20 Jan 2010

Telaprevir effective in HCV patients

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that data from recent clinical trials suggest that Vertex/Johnson & Johnson/Mitsubishi Tanabe's telaprevir is efficacious in hepatitis C virus patients who have not responded to previous treatment with peg-IFN/ribavirin. In contrast, the efficacy of Merck's (formerly Schering-Plough) boceprevir in treatment nonresponders has yet to be proven.

20 Jan 2010

PTC Therapeutics initiates additional clinical trial of ataluren in boys and young men with nmDBMD

PTC Therapeutics, Inc. (PTC) today announced the initiation of an additional clinical trial of ataluren (PTC124®) in boys and young men with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD) who have permanently lost the ability to walk independently.

20 Jan 2010

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

Depomed, Inc. announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of menopausal hot flashes.

20 Jan 2010

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

Drug Trial News

Dosing in First-in-Man Phase I study of 4SC AG's 4SC-203 commenced

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

PROLOR Biotech's hGH-CTP Phase I study data to be presented at the BIO CEO & Investor Conference

Telaprevir effective in HCV patients

PTC Therapeutics initiates additional clinical trial of ataluren in boys and young men with nmDBMD

Depomed plans additional Serada Phase 3 trial for treatment of menopausal hot flashes

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

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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