Efficacy News and Research

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Galeterone safe, effective for patients with CRPC

Patients with castration-resistant prostate cancer had limited side effects and in many cases a drop in prostate-specific antigen expression with galeterone (TOK-001), a small-molecule oral drug, according to phase I data presented at the AACR Annual Meeting 2012, held here March 31 - April 4.

2 Apr 2012

Tokai Pharmaceuticals announces data from galeterone Phase 1 trial for CRPC

Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that its lead candidate galeterone (TOK-001) was well-tolerated with minimal side effects and demonstrated efficacy in patients with castration-resistant prostate cancer (CRPC) in a Phase 1 study.

2 Apr 2012

Sleep deprivation does not disturb performance of interventionists during PCI procedures

A single-center study found that percutaneous coronary intervention (PCI) procedures performed during the middle of the night do not adversely affect the safety and effectiveness of procedures performed the next day by the same operator.

31 Mar 2012

UH clinical trial to evaluate stool DNA testing for colon cancer

In a first-of-its-kind clinical trial, physician-scientists at University Hospitals (UH) Case Medical Center's Seidman Cancer Center and Case Western Reserve University School of Medicine are studying a promising new non-invasive technology for colon cancer screening. The four-year study is recruiting patients to compare the effectiveness of stool DNA (SDNA) testing with colonoscopy for detecting large colon polyps.

31 Mar 2012

Data from Cempra's CEM-101 Phase 2 trial on N. gonorrhoeae infections to be presented at ECCMID

Cempra Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrating that CEM-101 (solithromycin) is active against antibiotic-resistant strains of N. gonorrhoeae.

31 Mar 2012

Data from Cempra's CEM-101 Phase 2 trial on CABP to be presented at ECCMID

Cempra Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases,today announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in London, March 31 to April 3,demonstrating CEM-101's (solithromycin's) efficacy to be comparable to levofloxacin in a Phase 2 trial of patients with community-acquired bacterial infections.

31 Mar 2012

ImmunoGen commences IMGN901 Phase II evaluation for SCLC

ImmunoGen, Inc. today announced that it has initiated Phase II testing of its IMGN901 product candidate for first-line treatment of SCLC.

31 Mar 2012

Top-line results from Shire's SPD476 phase 3 trial on diverticulitis

Shire plc, the global specialty biopharmaceutical company, today announced top-line results of the PREVENT2 trial, a phase 3 investigational study of once-daily SPD476, MMX mesalamine in patients with a history of diverticulitis.

31 Mar 2012

Bionovo 2011 total revenues decrease to $0.3 million

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced financial results for the year ended December 31, 2011.

31 Mar 2012

AlphaCore Pharma commences ACP-501 Phase 1 study in coronary arterial disease

AlphaCore Pharma, a biopharmaceutical company developing ACP-501 (rhLCAT) for the treatment of high risk atherosclerosis and serious lipid metabolism disorders, today announced the initiation of a Phase 1 study of ACP-501 in patients with stable coronary arterial disease.

31 Mar 2012

Cancer patients with CDI may benefit from DIFICLIR drug

New data presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrate that in cancer patients with CDI, DIFICLIR(fidaxomicin) may offer significant benefits in terms of clinical cure, recurrence and sustained clinical cure.

31 Mar 2012

Study evaluates efficacy of CBT in obsessive-compulsive disorder

This study evaluates the efficacy of a specialized form of psychotherapy (cognitive behavioral therapy) in clinical presentations characterized by the joint presence of obsessions and psychotic symptoms.

30 Mar 2012

Positive results from Genentech's T-DM1 Phase III trial on HER2-positive mBC

ImmunoGen, Inc., a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology, today announced that Roche has announced positive topline results from its trastuzumab emtansine (T-DM1) EMILIA Phase III trial.

30 Mar 2012

FDA extends review period for Almirall and Forest Labs' aclidinium bromide NDA

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease.

29 Mar 2012

Navidea announces data from Lymphoseek Phase 3 study on oral and squamous cell cancers

Navidea Biopharmaceuticals, Inc., a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Phase 3 clinical study investigating 99m-Tc-Tilmanocept in oral and squamous cell cancers (SCC) were presented as a poster presentation at the 65th Annual Cancer Symposium of the Society of Surgical Oncology (SSO) meeting held in Orlando, Florida, March 21-24, 2012.

29 Mar 2012

New treatment approach halts spread of cancer cells into normal brain tissue

Treating invasive brain tumors with a combination of chemotherapy and radiation has improved clinical outcomes, but few patients survive longer than two years after diagnosis. The effectiveness of the treatment is limited by the tumor's aggressive invasion of healthy brain tissue, which restricts chemotherapy access to the cancer cells and complicates surgical removal of the tumor.

29 Mar 2012

Researchers design new treatment approach for invasive brain tumors

Researchers from Emory and the Georgia Institute of Technology have designed a new treatment approach that appears to halt the spread of cancer cells into normal brain tissue in animal models.

29 Mar 2012

DSMB recommends Bionovo to continue Menerba Phase 3 trial for hot flashes

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today that the Company's independent Data Safety Monitoring Board (DSMB) recommended that the Phase 3 trial of Menerba (MF101) could continue as designed after an initial review of its clinical safety and tolerability data.

29 Mar 2012

Stem Cells reports results of Neuralstem ALS Phase I trial

Neuralstem, Inc. announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, Stem Cells, on March 13th.

29 Mar 2012

Scientists explore number of strategies to prevent anesthesia-induced injury in infants

Recent clinical studies have shown that general anesthesia can be harmful to infants, presenting a dilemma for both doctors and parents. But new research at Wake Forest Baptist Medical Center may point the way to treatment options that protect very young children against the adverse effects of anesthesia.

29 Mar 2012