Efficacy News and Research

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Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber model of allergic rhinitis caused by natural exposure to seasonal allergens.

14 Jul 2010

Presidio Pharmaceuticals completes Phase 1a clinical trial of PPI-461 in healthy subjects

Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a clinical trial of PPI-461, its lead HCV NS5A inhibitor, in healthy subjects. This first-in-human trial evaluated four single doses of PPI-461, followed by a five-day, once-a-day treatment regimen with PPI-461 at the highest tested dose.

14 Jul 2010

Eban-based HIV/STD risk-reduction intervention improves safe-sex habits among high-risk African-American couples

A new study has found that heterosexual African American couples in which only one partner is HIV-positive practiced safer sexual behaviors after participating in a culturally specific intervention program designed to reduce the risk of HIV and other sexually transmitted diseases.

14 Jul 2010

Highlights of AAPM 52nd meeting

The 52nd meeting of the American Association of Physicists in Medicine (AAPM) convenes from July 18 - 22, 2010 in Philadelphia, PA.

14 Jul 2010

New research studies presented at Alzheimer's Association International Conference

The primary therapeutic target in Alzheimer's disease has been the beta amyloid peptide, which clusters outside cells in the brain to form sticky clumps known as plaques. Recently, more attention has been given to the tau protein, which aggregates inside the brain cells of people with Alzheimer's, forming neurofibrillary tangles. Precisely how these proteins interact in causing the disease is unclear.

14 Jul 2010

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Supernus Pharmaceuticals, Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States.

14 Jul 2010

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

Fredericksburg Oncology is now accepting patients for a new clinical trial supported by the National Cancer Institute (NCI) to evaluate treatment for metastatic (advanced stage) melanoma. The current trial, designed at the Mayo Clinic, combines chemotherapy with targeted molecular agents in an effort to improve control of this difficult disease, reports Dr. Frederick C. Tucker, Jr., who heads this practice.

13 Jul 2010

New research shows Weight Watchers helps people lose weight effectively

New research unveiled at the International Congress on Obesity is further evidence of how Weight Watchers helps people around the world lose weight effectively, and has the potential to collaborate further with public health care providers worldwide to help reverse the obesity epidemic.

13 Jul 2010

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

MAP Pharmaceuticals, Inc. today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers.

13 Jul 2010

DST Health Solutions announces 5-I Compliance Accelerator Program

DST Health Solutions, LLC today announced its 5-I Compliance Accelerator Program, designed to help health plans successfully prepare major business systems for compliance with upcoming federal regulations. Within two years, the Centers for Medicare & Medicaid Services (CMS) will require healthcare organizations to begin using new standards for electronic transactions and within three years new diagnostic and procedure code sets – a regulatory challenge being dubbed "healthcare's Y2K."

13 Jul 2010

Ophthalmology professor receives $60,000 RPB award to research Sjogren's syndrome

Hui Shao, MD, PhD, associate professor of ophthalmology and visual sciences at the University of Louisville School of Medicine, has received a $60,000 Lew R. Wasserman Merit Award from the Research to Prevent Blindness (RPB) organization. The grant will help fund Shao's research of Sjogren's syndrome, a chronic autoimmune disease that targets the salivary and lacrimal glands - the glands that produce saliva and tears, respectively - resulting in dry mouth and dry eye symptoms.

13 Jul 2010

BIOTRONIK publishes final results of landmark TRUST Trial in Circulation

BIOTRONIK, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, announced today that the final results of the landmark TRUST Trial (Lumax-T/Lumos-T Safely RedUceS RouTine Office Device Follow-Up) have been published in the July 27, 2010 issue of Circulation. BIOTRONIK Home Monitoring is the industry's first and most advanced wireless remote monitoring system for patients with cardiac devices.

13 Jul 2010

CSHL scientists reverse symptoms of Type III SMA using ASOs

The devastating, currently incurable motor-neuron disease spinal muscular atrophy might soon be treated with tiny, chemically modified pieces of RNA called antisense oligonucleotides.

13 Jul 2010

Preclinical results of TH-302 presented at AACR Translational Cancer Medicine Meeting

Threshold Pharmaceuticals, Inc., today announced two preclinical presentations on its clinical stage hypoxia-activated prodrug, TH-302, at the American Association for Cancer Research Translational Cancer Medicine Meeting, being held July 11 to 14, 2010, in San Francisco, CA. The preclinical presentations describe new findings regarding the efficacy of TH-302 when combined with multi-kinase inhibitors that inhibit VEGF signaling, as well as the efficacy of TH-302 in combination with gemcitabine in models of pancreatic cancer.

13 Jul 2010

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

Cumberland Pharmaceuticals Inc. today announced that data supporting the efficacy of Caldolor in treating fever associated with falciparum malaria was published in the July edition of the peer-reviewed American Journal of Tropical Medicine and Hygiene. The study, which is the first to document an antipyretic effect of an injectable non-steroidal anti-inflammatory drug on fever caused by malaria, demonstrated that patients who received intravenous ibuprofen experienced a greater reduction in their temperatures than those who received placebo.

13 Jul 2010

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

12 Jul 2010

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

12 Jul 2010

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec and Swedish Orphan Biovitrum AB today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Efficacy News and Research

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

Presidio Pharmaceuticals completes Phase 1a clinical trial of PPI-461 in healthy subjects

Eban-based HIV/STD risk-reduction intervention improves safe-sex habits among high-risk African-American couples

Highlights of AAPM 52nd meeting

New research studies presented at Alzheimer's Association International Conference

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

New research shows Weight Watchers helps people lose weight effectively

MAP Pharmaceuticals reports results from LEVADEX PK and safety clinical trial in smokers, non-smokers

DST Health Solutions announces 5-I Compliance Accelerator Program

Ophthalmology professor receives $60,000 RPB award to research Sjogren's syndrome

BIOTRONIK publishes final results of landmark TRUST Trial in Circulation

CSHL scientists reverse symptoms of Type III SMA using ASOs

Preclinical results of TH-302 presented at AACR Translational Cancer Medicine Meeting

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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