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Two patents issued for GlycoMimetics lead drug candidate, related compounds

GlycoMimetics, Inc., a clinical-stage biotechnology company developing a new class of glycobiology-based therapies for a broad range of indications, today announced that the U. S. Patent and Trademark Office has issued two patents covering the company's lead drug candidate and related compounds. One patent, US number 7,728,117, specifically covers GMI-1070, the Company's drug candidate now in clinical trials of patients with vaso-occlusive crisis of sickle cell disease. The second patent, US number 7,741,312, contains claims covering a family of molecules that includes and extends beyond GMI-1070.

15 Jul 2010

AVAC Report surveys state of biomedical HIV prevention research

A new report from AVAC surveys the state of biomedical HIV prevention research, including the first evidence of vaccine-induced protection in humans and the emergence of ARV-based prevention -- and provides strategic recommendations for moving forward in a time of constrained resources and faltering commitment to ending AIDS.

15 Jul 2010

AMS reports positive results from clinical trial of MiniArc Single-Incision Sling System for SUI

American Medical Systems® (AMS), a leading provider of world-class devices and therapies for both male and female pelvic health, today announced results of a prospective, multi-center study on their market leading MiniArc Single-Incision Sling System for female stress urinary incontinence (SUI). The study concludes that MiniArc efficacy rates for negative cough stress test (CST) and 1-hr Pad Weight Test (PWT) at 12 months were 90.6 percent and 84.5 percent, respectively.

15 Jul 2010

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the first Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

15 Jul 2010

Aastrom commences extension study for control patients from Phase 2 IMPACT-DCM clinical trial

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced the initiation of an extension study for control patients from the company's ongoing open-label Phase 2 IMPACT-DCM clinical trial in patients with dilated cardiomyopathy (DCM).

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

Scientists discover three human antibodies that neutralize HIV

Scientists have discovered three previously unknown human antibodies that neutralize HIV, two of which target a broad range of HIV strains. The findings, reported online July 8 in two Science papers, add a level of encouragement to the AIDS vaccine research field.

14 Jul 2010

Scientists update criteria for diagnosis of Alzheimer's disease

Scientists at the Alzheimer's Association International Conference on Alzheimer's Disease 2010 today presented the first draft reports from three workgroups convened by the National Institute on Aging and the Alzheimer's Association to update the diagnostic criteria for Alzheimer's disease for the first time in 25 years.

14 Jul 2010

Study suggests protein interferon therapy for individuals with asthma

An immune-system protein already used to treat diseases like multiple sclerosis, hepatitis C and a variety of cancers might also aid asthma patients, UT Southwestern Medical Center researchers have found.

14 Jul 2010

ACRO releases statement regarding proposed privacy rule from HHS

The Association of Clinical Research Organization is pleased that the proposed privacy rule from Department of Health and Human Services strikes an appropriate balance between the critical needs of researchers for access to health information and the desire to protect the privacy of individual's health records.

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

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

Hi-Tech Pharmacal Co., Inc. today reported results for the fourth quarter and year ended April 30, 2010.

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

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia™: Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.

13 Jul 2010

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

BioSante Pharmaceuticals, Inc. today announced the initiation of a LibiGel (testosterone gel) clinical trial to evaluate its effect on cognitive function in menopausal women. The trial is a randomized, 6-month comparison of the effect of LibiGel compared to placebo treatment on a variety of learning and memory tasks. The study is being conducted by Dr. Susan Davis, Professor of Women's Health, Department of Medicine, Monash University Women's Health Program in Australia.

13 Jul 2010

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

A new study, published in the July issue of Advances in Therapy, revealed that a novel saw palmetto extract, SPET-085, is as effective as finasteride, the standard prescription drug therapy, in blocking the critical enzyme that leads to benign prostatic hyperplasia.

13 Jul 2010

Bio-Optronics, CRA partner to enhance clinical trial sites' patient recruitment capabilities

Bio-Optronics and Clinical Research Associates (CRA) have developed a strategic relationship to provide a turn-key solution for a clinical research site's patient recruitment needs, which couples Bio-Optronics' Clinical Conductor™ Clinical Trial Management System (CTMS) and Clinical Research Associates' patient recruitment offerings.

12 Jul 2010

MiCK assay effective in predicting best chemotherapy response for Endometrial Cancer patients: Study

Oncologists working with DiaTech Oncology have published the results of a comprehensive study to determine the effectiveness of the Microculture Kinetic (MiCK) assay for apoptosis in predicting the best chemotherapy response for Endometrial Cancer patients. (Journal of Gynecologic Oncology March 2010 Mar)

12 Jul 2010

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

A second-generation experimental anti-obesity and diabetes drug has shown promise in reducing body weight in rodents just as effectively as the predecessor rimonabant while avoiding the risk of psychiatric side effects that led to the withdrawal of rimonabant from the market and stopped further development of other brain-penetrating drugs of its type.

12 Jul 2010

Clinical Trial News and Research

Two patents issued for GlycoMimetics lead drug candidate, related compounds

AVAC Report surveys state of biomedical HIV prevention research

AMS reports positive results from clinical trial of MiniArc Single-Incision Sling System for SUI

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Aastrom commences extension study for control patients from Phase 2 IMPACT-DCM clinical trial

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

Scientists discover three human antibodies that neutralize HIV

Scientists update criteria for diagnosis of Alzheimer's disease

Study suggests protein interferon therapy for individuals with asthma

ACRO releases statement regarding proposed privacy rule from HHS

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Fredericksburg Oncology invites participants for new metastatic melanoma clinical trial

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

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

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

Bio-Optronics, CRA partner to enhance clinical trial sites' patient recruitment capabilities

MiCK assay effective in predicting best chemotherapy response for Endometrial Cancer patients: Study

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

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