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Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Naval Health Research Center for preclinical studies evaluating Adamas' triple combination antiviral drug (TCAD) therapy for influenza A, including novel influenza A/H1N1. TCAD therapy includes Adamas' investigational proprietary fixed-dose oral combination drug, to be administered adjunctively with a neuraminidase inhibitor, including Tamiflu (oseltamivir phosphate, Roche).

22 Aug 2009

Cortex Pharmaceuticals receives delisting notification from NYSE Amex

Cortex Pharmaceuticals, Inc. (NYSE Amex (COR)) reported that it has received a delisting notification from the NYSE Amex LLC indicating that it has not accepted the Company’s plan to regain compliance with the Exchange’s continued listing standards, as submitted by the Company in June.

21 Aug 2009

HeartWare achieves enrollment milestone under its ADVANCE Clinical Trial in the U.S

HeartWare International, Inc. (Nasdaq: HTWR - ASX: HIN) today announced that HeartWare has surpassed 50 implants in the United States under its ADVANCE Clinical Trial, marking an important early enrollment milestone.

21 Aug 2009

Results of PCF funded study could impact the standard of care for prostate cancer patients

Twice-yearly intravenous infusion with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer. The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, was published today in the print edition of the New England Journal of Medicine (NEJM). Both fundamental research on rank ligand (RANKL) in prostate cancer bone metastasis and other molecular factors involved in the denosumab study were supported at Massachusetts General Hospital with funding from the Prostate Cancer Foundation (PCF).

21 Aug 2009

MicroPhage's new platform for rapid identification of bacterial infections

MicroPhage announced today the launch of its multi-site clinical trial to support a U.S. Food and Drug Administration (FDA) premarket notification [510(k)]. The platform has been developed to rapidly identify bacterial infections and determine antibiotic susceptibility or resistance to aid physicians in antibiotic management.

21 Aug 2009

Endologix publishes abdominal aortic aneurysm treatment trial results online

Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today the online publication of results from the pivotal prospective, multicenter clinical trial of the Company's Powerlink XL((R)) System for treatment of abdominal aortic aneurysm in large diameter proximal aortic necks.

21 Aug 2009

Omnicomm's TrialMaster EDC solution chosen by Impax Pharmaceuticals for study in Parkinson's disease

OmniComm Systems, Inc. (OTC Bulletin Board: OMCM), one of the fastest growing companies in the EDC marketplace, today announced that Impax Pharmaceuticals, the brand division of Impax Laboratories, Inc., Hayward, CA, has selected the TrialMaster EDC solution for conducting a Phase III study in patients with Parkinson's Disease. "While managing a global multi site clinical trial there can be significant challenges in getting trial data when you want it and in the format that you need it," said Suneel Gupta, PhD, Chief Scientific Officer for Impax. "The TrialMaster EDC solution provides us with an intuitive and easy to use export tool that simplifies the process. After considering multiple different EDC solutions, we selected OmniComm Systems based on its customer driven approach and reputation for delivering unparalleled service and support. Additionally, its support of industry standards has enabled us to meet our very tight corporate timelines for this important study."

21 Aug 2009

NY-ESO-1 recombinant proteins to be used in clinical trials for treating melanoma and ovarian cancer

The Bioproduction Facility at Cornell University has produced the first batch of NY-ESO-1 recombinant protein-a cancer vaccine-that will be used in clinical trials for patients facing either ovarian cancer or melanoma. The facility was developed as a partnership between The Ludwig Institute for Cancer Research and Cornell University.

21 Aug 2009

Coping with burn injuries

More than half a million Americans are treated for burn injuries every year, but many do not have the specific skills necessary to cope with the experience of living with a burn injury after they leave the hospital.

20 Aug 2009

SCS becomes the first IT systems integration services provider to join Medidata’s ASPire to Win program

Medidata Solutions, a leading global provider of hosted clinical development solutions, today announced that Sumisho Computer Systems Corporation (SCS) has become the first IT systems integration services provider to join Medidata’s ASPire to Win® program for contract research organizations (CROs) and service providers.

20 Aug 2009

Pfizer collaborates with Private Access to address concerns regarding research and clinical trials

Recognizing that patient participation in clinical trials is the key to progress in medical research, Pfizer Inc announced today that it has entered into a collaboration with Private Access, the innovator in privacy-enhanced search technology, to create a new online community aimed at increasing clinical trial awareness and participation. The site will be the first to focus on patient privacy rights to connect patients, physicians and researchers with tailored information, tools and technology that will lead to more informed decisions about patient care, including clinical trial participation industry-wide.

20 Aug 2009

Peplin completes four-week enrolment phase for REGION-Ib trial

Peplin, Inc. (ASX:PLI) today announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities. This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.

20 Aug 2009

Inovio Biomedical records $2.9 million revenues in the six months ended June 30, 2009

Inovio Biomedical Corporation (NYSE AMEX: INO) (“Inovio”) today reported financial results for the three and six months ended June 30, 2009. Total revenue of $2.5 million and $2.9 million for the three and six months ended June 30, 2009, compared to $663,000 and $1.3 million for the three and six months ended June 30, 2008, respectively.

20 Aug 2009

Research reveals effectiveness of carvedilol in preventing variceal hemorrhage

Patients with cirrhosis are at risk for developing portal hypertension that can lead to the formation, dilation, and rupture of esophageal varices. The annual incidence of esophageal varices is approximately 5% and one third of those will bleed.

20 Aug 2009

Cardiovascular Systems' revenues in fourth-quarter of 2009 increases to $15.7 million

Cardiovascular Systems, Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today reported financial results for its fourth quarter and fiscal year ended June 30, 2009.

19 Aug 2009

The Gambia introduces pneumococcal immunisation programme

The Gambia, Minister of Health Dr. Mariatou Jallow administered the first dose of the pneumococcal vaccine to Gambian children at a rural clinic outside Banjul today. Joined by the Gambia’s Vice President, Mrs. Isatou Njie-Saidy, Dr. Jallow and hundreds of Gambian citizens celebrated this historic event, which marks the first step in the rollout of the Gambia’s national pneumococcal immunisation programme.

19 Aug 2009

Health Research International publishes reports on opportunities presented by transcatheter and minimally invasive surgical valve technologies

Transcatheter heart valve technologies are positioned to become the next disruptive influence in cardiovascular medicine and drive a multi-billion dollar market. However, questions remain about the timing of adoption of these new technologies, the numbers and types of patients ultimately benefitting from them, the impact of reimbursement, and where transcatheter technologies pose the greatest threat to the current surgical caseload, especially in light of developments in minimally invasive heart valve surgery technologies.

19 Aug 2009

Light Sciences Oncology announces Phase 2 trial of Aptocine in Benign Prostatic Hyperplasia

Light Sciences Oncology, Inc. (LSO) today announced the treatment of the first patients in a Phase 2 clinical trial of its innovative targeted drug treatment Aptocine(TM) (talaporfin sodium) in Benign Prostatic Hyperplasia (BPH). The Phase 2 trial expands the Aptocine BPH development program on the basis of a Phase 1 study at escalating light doses. In the open-label Phase 2 trial, Aptocine is being tested for safety and efficacy in 40 patients with lower urinary tract symptoms (LUTS) due to BPH. Aptocine is also in two Phase 3 clinical trials for solid tumors in the liver as well as preclinical development for prostate cancer.

19 Aug 2009

Neovasc reports Q2 2009 financials

"During the second quarter we continued to make significant progress in executing on our strategic initiatives adopted late last year," said Alexei Marko, chief executive officer of Neovasc. "We are especially pleased at the growing traction we are seeing in our tissue business, where our decision to focus on our specialty products and services is beginning to bear fruit, with increases in tissue sales already evident.

19 Aug 2009

Genetic mutation that helps regulate high blood pressure is a cause of inherited kidney disease

The discovery provides insight into a protein, renin, that is important in blood pressure regulation, and reveals the cause of one type of inherited kidney disease occurring in adults and children, said co-investigator Anthony Bleyer, M.D., professor of internal medicine-nephrology at the School of Medicine.

19 Aug 2009

Clinical Trial News and Research

Adamas Pharmaceuticals forges agreement with U.S. Naval Health Research Center for evaluating triple combination antiviral drug

Cortex Pharmaceuticals receives delisting notification from NYSE Amex

HeartWare achieves enrollment milestone under its ADVANCE Clinical Trial in the U.S

Results of PCF funded study could impact the standard of care for prostate cancer patients

MicroPhage's new platform for rapid identification of bacterial infections

Endologix publishes abdominal aortic aneurysm treatment trial results online

Omnicomm's TrialMaster EDC solution chosen by Impax Pharmaceuticals for study in Parkinson's disease

NY-ESO-1 recombinant proteins to be used in clinical trials for treating melanoma and ovarian cancer

Coping with burn injuries

SCS becomes the first IT systems integration services provider to join Medidata’s ASPire to Win program

Pfizer collaborates with Private Access to address concerns regarding research and clinical trials

Peplin completes four-week enrolment phase for REGION-Ib trial

Inovio Biomedical records $2.9 million revenues in the six months ended June 30, 2009

Research reveals effectiveness of carvedilol in preventing variceal hemorrhage

Cardiovascular Systems' revenues in fourth-quarter of 2009 increases to $15.7 million

The Gambia introduces pneumococcal immunisation programme

Health Research International publishes reports on opportunities presented by transcatheter and minimally invasive surgical valve technologies

Light Sciences Oncology announces Phase 2 trial of Aptocine in Benign Prostatic Hyperplasia

Neovasc reports Q2 2009 financials

Genetic mutation that helps regulate high blood pressure is a cause of inherited kidney disease

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