Clinical Trial News and Research

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People with high diastolic blood pressure more likely to have cognitive impairment

High blood pressure is linked to memory problems in people over 45, according to research published in the August 25, 2009, print issue of Neurology, the medical journal of the American Academy of Neurology.

24 Aug 2009

Orphan drug status granted to BioCancell's BC-819 drug

Tikcro Technologies today announced that the United States (“US”) Department of Health and Human Services ("HHS") has granted orphan drug status to BioCancell's BC-819 drug, currently in Phase I/IIa clinical trials, for its use in treating ovarian cancer.

24 Aug 2009

Retigabine's Phase IIa clinical trial preliminary results announced

Valeant Pharmaceuticals International today announced preliminary results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles.

24 Aug 2009

CSL Biotherapies initiates clinical trials of Influenza A/H1N1 2009 vaccine in the US

CSL Biotherapies has announced the initiation of the company’s first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. The studies will determine the safety of CSL’s candidate vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in adults and children.

24 Aug 2009

Curemark Founder delivers Industry Keynote address at Epigenomics Conference 2009

Curemark Founder and CEO Dr. Joan Fallon delivered the Industry Keynote address at the Third International Epigenomics, Sequencing 2009 Conference at Harvard Medical School on July 14th

24 Aug 2009

Synexus acquires three more clinical trial centres in Poland

Synexus’ expansion in Central and Eastern Europe has been boosted with the acquisition of three more clinical trial centres in Poland.

From AES - Accelerated Enrollment Solutions 24 Aug 2009

Profibrix raises funds for clinical and preclinical development

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the successful closing of a US $11 million series B investment. The financing round was led by new investor Gilde Healthcare Partners, a leading European life sciences investor, who joins existing investor Index Ventures. Dirk Kersten from Gilde will join the company's Supervisory Board.

24 Aug 2009

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

Clinical Trial News and Research

People with high diastolic blood pressure more likely to have cognitive impairment

Orphan drug status granted to BioCancell's BC-819 drug

Retigabine's Phase IIa clinical trial preliminary results announced

CSL Biotherapies initiates clinical trials of Influenza A/H1N1 2009 vaccine in the US

Curemark Founder delivers Industry Keynote address at Epigenomics Conference 2009

Synexus acquires three more clinical trial centres in Poland

Profibrix raises funds for clinical and preclinical development

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

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