Clinical Trial News and Research

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Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today that they have entered into a global license and collaboration agreement to develop and commercialize OGX-011, as well as an agreement to purchase shares in OncoGenex. OGX-011 is a Phase III cancer therapy designed to inhibit cancer treatment resistance.

21 Dec 2009

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009

Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Organogenesis, Inc. announced today that it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its CelTx(TM), a living cellular construct for oral soft tissue regeneration. If approved, CelTx will be the first, living cell-based technology that is FDA-approved for use in the dental market.

21 Dec 2009

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Medicago Inc. a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

21 Dec 2009

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone 17,21-dipropionate (oral BDP), for the prevention of acute radiation enteritis.

21 Dec 2009

EMEA grants orphan drug designation for pixantrone in Europe

Cell Therapeutics, Inc. ("CTI") announced today that the European Medicines Agency (EMEA) has granted pixantrone orphan drug designation for the treatment of DLBCL which accounts for about 80% of aggressive non-Hodgkin's lymphoma.

21 Dec 2009

Only half of eligible heart failure patients receive implantable devices

A study of heart failure patients who meet national guidelines for devices that stabilize and strengthen the heart's electrical system found that only half of eligible patients received the devices.

19 Dec 2009

John Theurer Cancer Center presents over 20 research updates and trial results at the 2009 ASH meeting

Doctors and researchers from the John Theurer Cancer Center at Hackensack University Medical Center recently presented research updates and clinical trial results of more than 20 innovative studies at the American Society of Hematology (ASH) annual meeting from December 5-8, 2009.

18 Dec 2009

U.S. health officials announce shift in focus of prep trial in Botswana

U.S. health officials on Thursday announced they will shift the focus of a clinical trial in Botswana aimed at testing pre-exposure prophylaxis (PrEP) - the strategy that "a daily low dose of the drugs, which interfere with the ability of the virus to replicate, could also lower the risk of infection" - after researchers discovered they would be unable to determine the efficacy of Truvada, the medicine used in the trial, Reuters reports.

18 Dec 2009

Flamel Technologies initiates IFN-alpha-2b XL Phase 2a clinical trial for HCV

Flamel Technologies today announced the initiation of a Phase 2a clinical trial of Flamel’s Interferon alpha-2b XL (IFN-alpha-2b XL), which is based on Flamel’s Medusa® platform for controlled release of biologics. IFN-alpha-2b XL is being developed as a controlled release of unmodified interferon alpha-2b for the treatment of chronic hepatitis C virus (HCV).

18 Dec 2009

Proprietary adult stem cell platform, an effective treatment for diabetes, shows study

Australia's regenerative medicine company, Mesoblast Limited, today announced significant preclinical trial results showing that the proprietary adult stem cell platform could be an effective treatment for diabetes.

18 Dec 2009

BioMS Medical invests in Spectral Diagnostics to advance treatment for sepsis

Spectral Diagnostics Inc. and BioMS Medical Corp. today announced that BioMS Medical ("BioMS") and a syndicate of investors have invested $14 million in Spectral Diagnostics ("Spectral", or the "Company") to advance Toraymyxin(TM), a treatment for severe sepsis, towards regulatory approval and commercialization in the United States.

18 Dec 2009

Ambit Biosciences and Astellas Pharma to jointly develop and commercialize FLT3 kinase inhibitors

Ambit Biosciences Corporation and Astellas Pharma Inc. today announced that they have entered into a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications.

18 Dec 2009

ARIAD Pharmaceuticals completes enrollment of patients for Phase 3 clinical trial of ridaforolimus

ARIAD Pharmaceuticals, Inc. today announced the completion of patient enrollment in its pivotal, Phase 3 clinical trial of oral ridaforolimus, its investigational mTOR inhibitor, in patients with metastatic soft-tissue and bone sarcomas.

18 Dec 2009

Arno Therapeutics announces dosing of first patient in Phase II clinical study of AR-67

Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in a Phase II clinical study of its third-generation camptothecin compound, AR-67, in patients with Glioblastoma Multiforme (GBM), an aggressive form of brain cancer.

17 Dec 2009

Update on Phase 2 clinical trial of oral interferon announced by Amarillo Biosciences

Amarillo Biosciences, Inc. (ABI) today announced that its ongoing study of oral interferon as prevention/treatment of influenza and other respiratory illnesses in Perth, Australia is nearing completion.

17 Dec 2009

Positive results from DURECT's Phase IIb POSIDUR clinical trial for post-surgical pain

DURECT Corporation announced today positive results from a 60 patient Phase IIb clinical trial of POSIDUR(TM), a proprietary product under development for the treatment of post-surgical pain.

17 Dec 2009

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint was achieved in the Company’s Phase 2 pain study assessing the efficacy and safety of BEMA Buprenorphine. The positive results follow BDSI’s March 2009 announcement of favorable Phase 1 study results.

17 Dec 2009

Investigational study of TRT to alleviate debilitating effects of tinnitus commenced

A University of Alabama researcher is embarking on a $5.6 million phase-three, randomized, controlled clinical trial to evaluate the effectiveness of an innovative treatment that uses a noise-generating device, along with counseling, to alleviate the debilitating effects of tinnitus - that ringing in the ears that drives some people to distraction.

17 Dec 2009

Medifacts International announces new innovations in the use of telemedicine in clinical trials

MEDIFACTS INTERNATIONAL, INC., one of the largest global providers of noninvasive cardiovascular diagnostic services, today announced that they are once again leading the Cardiovascular Safety Services marketplace in innovation, expertise, and execution - this time with new innovations in the use of telemedicine, T-SMBP (Telemonitoring Self Measured Blood Pressure), in clinical trials.

17 Dec 2009

Clinical Trial News and Research

Teva Pharmaceutical Industries, OncoGenex Pharmaceuticals announce collaboration in cancer therapy

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Soligenix commences SGX201 Phase 1/2 clinical trial for acute radiation enteritis prevention

EMEA grants orphan drug designation for pixantrone in Europe

Only half of eligible heart failure patients receive implantable devices

John Theurer Cancer Center presents over 20 research updates and trial results at the 2009 ASH meeting

U.S. health officials announce shift in focus of prep trial in Botswana

Flamel Technologies initiates IFN-alpha-2b XL Phase 2a clinical trial for HCV

Proprietary adult stem cell platform, an effective treatment for diabetes, shows study

BioMS Medical invests in Spectral Diagnostics to advance treatment for sepsis

Ambit Biosciences and Astellas Pharma to jointly develop and commercialize FLT3 kinase inhibitors

ARIAD Pharmaceuticals completes enrollment of patients for Phase 3 clinical trial of ridaforolimus

Arno Therapeutics announces dosing of first patient in Phase II clinical study of AR-67

Update on Phase 2 clinical trial of oral interferon announced by Amarillo Biosciences

Positive results from DURECT's Phase IIb POSIDUR clinical trial for post-surgical pain

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

Investigational study of TRT to alleviate debilitating effects of tinnitus commenced

Medifacts International announces new innovations in the use of telemedicine in clinical trials

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