Clinical Trial News and Research

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Polypill may serve as viable option for developing countries to treat CVD risk prevention

For a patient at high risk of cardiovascular disease, keeping up with what pills to take at different times of the day can be tedious. Window sills lined with prescription bottles - a pill for cholesterol, another for blood pressure, and an aspirin to keep blood thin and flowing - the list can get quite long and, as a result, many people, especially the elderly, often forget doses or take the wrong pill at the wrong time.

22 Mar 2011

FDA accepts Arisaph's ARI-3037MO IND for phase I human clinical trial

Arisaph Pharmaceuticals, Inc., a privately held drug discovery biopharmaceutical company, today announced that the U.S. Food and Drug Administration has accepted the Company's recently submitted Investigational New Drug application to evaluate ARI-3037MO in a phase I human clinical trial in healthy volunteers.

22 Mar 2011

BMY's ipilimumab Phase III study against metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company today announced that a clinical trial -- known as study 024 -- of its investigational compound ipilimumab has met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma.

22 Mar 2011

Cephalon to acquire Gemin X Pharmaceuticals

Cephalon, Inc. announced today that it has signed a definitive merger agreement under which it will acquire all of the outstanding capital stock of Gemin X Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing first-in-class cancer therapeutics, for $225 million cash on a cash-free, debt-free basis. Gemin X stockholders could also receive up to $300 million in cash payments upon the achievement of certain regulatory and sales milestones.

22 Mar 2011

Second US trial in HIV/AIDS lymphoma patients using Benitec’s ddRNAi technology

Benitec Limited (ASX:BLT), a company involved in RNA-based gene silencing for human therapeutics, announced that the City of Hope research hospital in Duarte, California is planning to initiate a second small Phase I/II study using Benitec’s DNA-directed RNA interference (ddRNAi) technology in lymphoma patients carrying the HIV virus. The aim of the study is to optimize the treatment by modifying a range of clinical parameters.

21 Mar 2011

Svelte Medical completes 6 month follow up in initial Acrobat angioplasty system clinical trial

Svelte™ Medical Systems, Inc. is pleased to announce that it has completed 6 month follow up in its initial clinical trial with the Svelte Acrobat angioplasty system.

21 Mar 2011

Intravenous Phenoxodiol-cisplatin combination well tolerated in platinum resistant ovarian cancer

Marshall Edwards, Inc., an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today the publication of results from a Phase II clinical trial of intravenous Phenoxodiol in combination with cisplatin in women with platinum-resistant ovarian cancer.

21 Mar 2011

NasVax reports positive results from Phase 2a trial of oral immunotherapy for non-alcoholic steatohepatitis

NasVax announces the success of a Phase 2a clinical trial of a new oral immunotherapy for non-alcoholic steatohepatitis (NASH), an inflammatory disease associated with fatty liver disease and the metabolic syndrome.

21 Mar 2011

Echo Therapeutics fiscal 2010 net loss decreases to $4.1 million

Echo Therapeutics, Inc., a company developing its needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude™ SkinPrep System for transdermal drug delivery, today announced results for the year ended December 31, 2010.

21 Mar 2011

FDA clears Insmed IND for ARIKACE Phase 3 clinical trial in nontuberculous mycobacteria lung infections

Insmed Incorporated, a biopharmaceutical company, announced today that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA).

21 Mar 2011

Advanced Cell Technology reduces 2010 debt to less than $1 million

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today 2010 year-end results for the period ended December 31, 2010. The Company utilized $8.8 million in cash for operations during the year, compared to $5.1 million in the year-earlier period.

21 Mar 2011

Medicago launches clinical development of seasonal flu vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that the first dose of vaccine has been administered thereby initiating the Company's phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States. The primary safety and immunogenicity results for this trial are expected within three months.

21 Mar 2011

XenoPort reports preliminary top-line results from arbaclofen placarbil Phase 2b clinical trial in GERD

XenoPort, Inc. announced today preliminary top-line results from a Phase 2b clinical trial of arbaclofen placarbil (also known as AP) as adjunctive therapy in patients with gastroesophageal reflux disease (GERD) who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors (PPI).

21 Mar 2011

Positive results from GDC-0449 Phase II clinical trial in advanced basal cell carcinoma

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC).

21 Mar 2011

Almac, Exco InTouch enter exclusive integrated patient management alliance

The Almac Group and Exco InTouch announced today that Almac's Clinical Technologies business unit, the leading provider of IXRS(R) (Interactive Voice and Web Response) services relating to patient and drug supply management, has formed an exclusive integrated patient management alliance with Exco InTouch, an innovative firm specializing in patient recruitment, retention, compliance and ePRO services.

21 Mar 2011

$CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma$

CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma

Cell Therapeutics, Inc. today announced that it has initiated its randomized pivotal trial of pixantrone for the treatment of relapsed/refractory diffuse large B-cell lymphoma ("DLBCL").

21 Mar 2011

Genentech's vismodegib Phase II clinical study in advanced basal cell carcinoma meets primary endpoint

Genentech, a member of the Roche Group, today announced that a pivotal Phase II clinical study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a particularly severe and debilitating form of skin cancer.

21 Mar 2011

Potential bias seen in informed consent language when describing trials, say researchers

When presented with different terms to describe a clinical trial, parents were far more likely to consent to enroll their child if it was called a "research study" than if it was called a "medical experiment" or a "research project," in large part because they perceived the former as safer, even though that was not necessarily the case, according to a report in IRB: Ethics & Human Research.

19 Mar 2011

ACRIN, ECOG, NCI intent to merge their clinical cancer research programs

The American College of Radiology's Imaging Network and the Eastern Cooperative Oncology Group, National Cancer Institute Clinical Trials Cooperative Group members, today announced their intent to merge their clinical cancer research programs.

19 Mar 2011

The Lancet publishes Oceana's Solesta injectable gel study results against fecal incontinence

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced the publication of results from a randomized-controlled clinical trial of the bulking agent, NASHA DX, a dextranomer suspended in stabilized, which was injected into the submucosa of the anal canal in patients with fecal incontinence.

19 Mar 2011

Clinical Trial News and Research

Polypill may serve as viable option for developing countries to treat CVD risk prevention

FDA accepts Arisaph's ARI-3037MO IND for phase I human clinical trial

BMY's ipilimumab Phase III study against metastatic melanoma meets primary endpoint

Cephalon to acquire Gemin X Pharmaceuticals

Second US trial in HIV/AIDS lymphoma patients using Benitec’s ddRNAi technology

Svelte Medical completes 6 month follow up in initial Acrobat angioplasty system clinical trial

Intravenous Phenoxodiol-cisplatin combination well tolerated in platinum resistant ovarian cancer

NasVax reports positive results from Phase 2a trial of oral immunotherapy for non-alcoholic steatohepatitis

Echo Therapeutics fiscal 2010 net loss decreases to $4.1 million

FDA clears Insmed IND for ARIKACE Phase 3 clinical trial in nontuberculous mycobacteria lung infections

Advanced Cell Technology reduces 2010 debt to less than $1 million

Medicago launches clinical development of seasonal flu vaccine

XenoPort reports preliminary top-line results from arbaclofen placarbil Phase 2b clinical trial in GERD

Positive results from GDC-0449 Phase II clinical trial in advanced basal cell carcinoma

Almac, Exco InTouch enter exclusive integrated patient management alliance

CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma

Genentech's vismodegib Phase II clinical study in advanced basal cell carcinoma meets primary endpoint

Potential bias seen in informed consent language when describing trials, say researchers

ACRIN, ECOG, NCI intent to merge their clinical cancer research programs

The Lancet publishes Oceana's Solesta injectable gel study results against fecal incontinence

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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