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Bio-Path initiates enrollment in fourth cohort of Liposomal Grb-2 Phase I trial for blood cancers

Bio-Path Holdings, Inc., a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has begun enrolling patients into the fourth dosage cohort in its Phase I clinical trial of its lead product candidate, BP-100.1.01 (Liposomal Grb-2), which is being evaluated as a systemic treatment for blood cancers including acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS).

26 Jul 2012

Multi-center clinical trial results demonstrate safety and efficacy of carfilzomib for multiple myeloma

Researchers from John Theurer Cancer Center at HackensackUMC, one of the nation's 50 best hospitals for cancer, played leading roles in three separate multi-center studies with the new proteasome inhibitor carfilzomib published in Blood, a major peer-reviewed scientific journal.

26 Jul 2012

ImmunoCellular receives FDA IND clearance for ICT-121 Phase I trial in glioblastoma multiforme

ImmunoCellular Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has given clearance to a physician sponsored investigative new drug (IND) application to initiate a Phase I clinical trial of ICT-121, IMUC's novel dendritic-cell-based vaccine targeting CD-133, an antigen that is highly expressed by multiple solid tumors.

26 Jul 2012

Bard completes enrollment in Lutonix DCB clinical trial for peripheral arterial disease

C. R. Bard, Inc. today announced that its Lutonix technology center completed patient enrollment into its global, multicenter LEVANT 2 randomized clinical trial.

26 Jul 2012

Jennerex initiates JX-594 Phase 2 trial in advanced hepatocellular carcinoma

Jennerex, Inc., a private, clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic immunotherapies, today announced that the first patient has been treated in a Phase 2 clinical trial of intravenous treatment with JX-594 for patients with advanced hepatocellular carcinoma (HCC), or liver cancer, who have not received treatment with sorafenib—the current standard of care for this patient population.

26 Jul 2012

CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 1b clinical trial to determine the maximum tolerated dose and to evaluate preliminary efficacy of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies.

26 Jul 2012

Karyopharm commences two KPT-330 phase 1 studies in cancers

Karyopharm Therapeutics Inc., a leader in the new field of nuclear transport modulators, announced dosing of patients in the first-in-human clinical trials with KPT-330.

25 Jul 2012

EntreMed commences ENMD-2076 Phase 2 study in triple-negative breast cancer

EntreMed, Inc., a clinical-stage pharmaceutical company, announced today the initiation of a dual-institutional Phase 2 study of ENMD-2076 in triple-negative breast cancer. Jennifer R. Diamond, MD at the University of Colorado serves as the principal investigator for the study.

25 Jul 2012

New combination therapy for TB shows promise in Phase II study

"Results from a groundbreaking trial of three drugs given in combination -- one of them completely new and one not yet licensed for this use -- killed more than 99 percent of patients' [tuberculosis (TB)] bacteria after two weeks of treatment," and the combination "appears to be equally effective on drug-resistant TB," the Guardian reports.

25 Jul 2012

NBTI participates in ICT-107 phase II trial for glioblastoma multiforme

Researchers at Northwestern Brain Tumor Institute (NBTI) are seeking to understand if a vaccine made from a patient's own blood cells may slow the growth of a type of brain tumor.

25 Jul 2012

Merck signs two licensing agreements for investigational HIV drug candidates

Merck, known as MSD outside the United States and Canada, announced today that the company has signed two licensing agreements for investigational HIV drug candidates.

25 Jul 2012

Little evidence exists for potential HPV type competition in cross-sectional study

Vaccines against human papillomavirus (HPV) are now recommended by the Centers for Disease Control and Prevention for both teenage boys and girls. The vaccine protects against the two most common types of the virus that cause cervical cancer: HPV 16 and 18. Is there a chance that the increased number of people vaccinated might result in an increase of other types of HPV that cause cancer?

25 Jul 2012

Dapivirine Phase III trial now underway in Africa to treat HIV in women

A large clinical trial testing the long-term safety and effectiveness of a new approach for preventing HIV in women - a vaginal ring used once a month - is now underway in Africa, researchers announced today at the XIX International AIDS Conference (AIDS 2012).

25 Jul 2012

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

BioCryst Pharmaceuticals, Inc. announced favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment.

25 Jul 2012

Novel combination drug regimen could be more effective than existing treatments for TB

A novel approach to discover the first new tuberculosis (TB) combination drug regimen cleared a major hurdle when Phase II clinical trial results found it could kill more than 99 percent of patients' TB bacteria within two weeks and could be more effective than existing treatments, according to a study published today in the Lancet.

24 Jul 2012

Topline results from first of four Phase 3 studies of Pfizer's bapineuzumab for Alzheimer's

Pfizer Inc. announced today that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype.

24 Jul 2012

Pfizer’s Lyrica does not affect reproductive function in healthy males

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.

24 Jul 2012

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.

24 Jul 2012

TB combination drug trials progress

A novel approach to discover the first new tuberculosis (TB) combination drug regimen cleared a major hurdle when Phase II clinical trial results found it could kill more than 99 percent of patients’ TB bacteria within two weeks and could be more effective than existing treatments, according to a study published today in the Lancet. These results add to a growing body of evidence that the new regimen could reduce treatment by more than a year for some patients.

24 Jul 2012

Top-line result from Pfizer Bapineuzumab Phase 3 studies on Alzheimer's

Elan Corporation, plc announced today that Pfizer has issued a top-line result in the first of four Bapineuzumab Phase 3 studies carried out by Pfizer and Janssen AI.

24 Jul 2012

Drug Trial News

Bio-Path initiates enrollment in fourth cohort of Liposomal Grb-2 Phase I trial for blood cancers

Multi-center clinical trial results demonstrate safety and efficacy of carfilzomib for multiple myeloma

ImmunoCellular receives FDA IND clearance for ICT-121 Phase I trial in glioblastoma multiforme

Bard completes enrollment in Lutonix DCB clinical trial for peripheral arterial disease

Jennerex initiates JX-594 Phase 2 trial in advanced hepatocellular carcinoma

CytRx commences aldoxorubicin plus doxorubicin Phase 1b trial in advanced solid tumors

Karyopharm commences two KPT-330 phase 1 studies in cancers

EntreMed commences ENMD-2076 Phase 2 study in triple-negative breast cancer

New combination therapy for TB shows promise in Phase II study

NBTI participates in ICT-107 phase II trial for glioblastoma multiforme

Merck signs two licensing agreements for investigational HIV drug candidates

Little evidence exists for potential HPV type competition in cross-sectional study

Dapivirine Phase III trial now underway in Africa to treat HIV in women

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

Novel combination drug regimen could be more effective than existing treatments for TB

Topline results from first of four Phase 3 studies of Pfizer's bapineuzumab for Alzheimer's

Pfizer’s Lyrica does not affect reproductive function in healthy males

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

TB combination drug trials progress

Top-line result from Pfizer Bapineuzumab Phase 3 studies on Alzheimer's

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

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