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Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

23 Jul 2010

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

23 Jul 2010

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx's oncology drug candidate tamibarotene.

23 Jul 2010

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Inhibitex, Inc. today announced that the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB recommended that the trial continue to completion without modification.

23 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Achillion nominates ACH-2928 NS5A clinical candidate for treatment of HCV

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced the nomination of a lead clinical candidate in its fourth proprietary program against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.

22 Jul 2010

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis. The company has completed patient enrollment in this multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. In addition, Tarsa announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.

22 Jul 2010

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Merrimack Pharmaceuticals, Inc. and sanofi-aventis announced today that the first patient has received an initial dose in a Phase 2 randomized double blind clinical study combining MM-121 with exemestane (Aromasin®) in breast cancer patients.

22 Jul 2010

Repros granted IRB approval to commence low dose Proellex study

Repros Therapeutics Inc. today announced it has received IRB approval to commence the low dose Proellex® study. The contract for clinical services was previously awarded to ICON. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion. The study will test 5 different doses of Proellex (1, 3, 6, 9 and 12 mg) with 1 mg being the first dose tested. In previous studies a 12.5 mg dose was well tolerated and yielded statistically significant efficacy signals for both uterine fibroids and endometriosis.

22 Jul 2010

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.

22 Jul 2010

Fera acquires investigational new drug for treatment of fungal otitis externa

Fera Pharmaceuticals announces the acquisition of an investigational new drug to treat fungal otitis externa (FOE).

22 Jul 2010

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Onyx Pharmaceuticals, Inc. today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

22 Jul 2010

Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

Ampio Pharmaceuticals, Inc. today announced the initiation of a Phase II clinical trial of Optina™ for the treatment of diabetic macular edema, an early stage of diabetic retinopathy. Diabetic macular edema is responsible for most vision loss in patients with diabetes mellitus.

22 Jul 2010

AMRI initiates enrollment for Phase I study of ALB-127158 for obesity

AMRI has commenced enrollment for a Phase I study of ALB-127158(a), a novel MCH1 receptor antagonist offering a potential new approach for the treatment of obesity. The announcement was made yesterday during a presentation by AMRI's Dr. Peter Guzzo, director, discovery research and development, at the 6th Obesity and Diabetes Drug Development Summit in Arlington, VA. Preclinical data were also reported.

21 Jul 2010

Shionogi-ViiV Healthcare to advance '572 inhibitor into Phase III clinical trials

Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.

21 Jul 2010

NovaBay reports positive results from NVC-422 Phase 2a proof-of-concept clinical trial for impetigo

NovaBay Pharmaceuticals, Inc. today announced that its lead product candidate was safe and efficacious against the highly contagious skin infection impetigo in a Phase 2a proof-of-concept clinical trial. This dose-ranging study showed that the drug cleared impetigo infections, including those in the trial caused by a drug-resistant strain of bacteria called methicillin-resistant Staphylococcus aureus or MRSA. Impetigo afflicts approximately 1 million people, primarily infants and children, in the United States annually.

21 Jul 2010

PROLOR Biotech initiates Phase II clinical trial of biobetter version of human growth hormone

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced initiation of a Phase II clinical trial of hGH-CTP, the company's proprietary biobetter version of human growth hormone (hGH).

21 Jul 2010

AiCuris presents preclinical data on AIC246 anti-HCMV drug at International Herpesvirus Workshop

AiCuris announced today publication of preclinical data on AIC246, at the International Herpesvirus Workshop in Salt Lake City, Utah, USA from 24 – 29 July 2010. AIC246 is a novel anti-HCMV drug currently in clinical phase 2 testing.

21 Jul 2010

AIDS 2010: Study finds microbicide containing HIV drug lowers infection risk in women by 39%

A microbicide gel containing Gilead's HIV drug tenofovir used by women before and after sex has been shown to reduce their risk of HIV infection by nearly 40%, according to a study unveiled at the International AIDS Conference-AIDS 2010, Reuters reports

21 Jul 2010

Major turning point in antiepileptic drug testing, development

New York University researchers revealed that data from previously completed withdrawal to monotherapy studies for antiepileptic drugs provide a valid control for future studies, obviating the need for placebo/pseudo-placebo trials to demonstrate the efficacy of these drugs as monotherapy. Results of this study are now available online in Epilepsia, a journal published by Wiley-Blackwell on behalf of the International League Against Epilepsy.

21 Jul 2010

Drug Trial News

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Achillion nominates ACH-2928 NS5A clinical candidate for treatment of HCV

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Repros granted IRB approval to commence low dose Proellex study

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Fera acquires investigational new drug for treatment of fungal otitis externa

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

AMRI initiates enrollment for Phase I study of ALB-127158 for obesity

Shionogi-ViiV Healthcare to advance '572 inhibitor into Phase III clinical trials

NovaBay reports positive results from NVC-422 Phase 2a proof-of-concept clinical trial for impetigo

PROLOR Biotech initiates Phase II clinical trial of biobetter version of human growth hormone

AiCuris presents preclinical data on AIC246 anti-HCMV drug at International Herpesvirus Workshop

AIDS 2010: Study finds microbicide containing HIV drug lowers infection risk in women by 39%

Major turning point in antiepileptic drug testing, development

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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