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North Mississippi IRB approves CEL-SCI's Multikine Phase III clinical trial for head and neck cancer

CEL-SCI Corporation announced today it has received approval from the North Mississippi Health Services Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare.

13 Sep 2010

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial.

13 Sep 2010

Relypsa completes $70M Series B financing

Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced the completion of a Series B financing totaling $70 million. OrbiMed Advisors, LLC, led the financing with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners.

13 Sep 2010

Jennerex reports positive interim data from trial of JX-594 and sorafenib for liver cancer

Jennerex, Inc., a clinical-stage biotherapeutics company focused on the development of first-in-class, targeted oncolytic products for cancer, today reported positive interim data from a pilot trial using JX-594 followed by sorafenib (Nexavar®) to treat liver cancer patients. The data were presented today at the Fourth Annual International Liver Cancer Association Conference in Montreal, Canada.

13 Sep 2010

Pro-Pharmaceuticals engages Numoda Corporation to optimize DAVANAT Phase III clinical trial

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has engaged the Numoda Corporation, a leading information, process and logistics management company, to oversee the Phase III clinical trial of DAVANAT and 5-FU compared with the standard of care in the treatment of patients with advanced, metastatic colorectal cancer.

13 Sep 2010

ARIAD commences ponatinib Phase 2 clinical trial in Ph+ ALL and chronic myeloid leukemia

ARIAD Pharmaceuticals, Inc. today announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL).

13 Sep 2010

XenoPort intends to initiate Phase 3 XP19986 trial for multiple sclerosis

XenoPort, Inc. announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients.

13 Sep 2010

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

13 Sep 2010

Seattle Genetics' lintuzumab phase IIb clinical trial for AML does not meet primary endpoint

Seattle Genetics, Inc. today announced that its phase IIb clinical trial of lintuzumab (SGN-33) in older patients with acute myeloid leukemia (AML) did not meet its primary endpoint of extending overall survival. Lintuzumab is a naked monoclonal antibody that targets the CD33 antigen. As a result of the outcome of this trial, the company will discontinue its development program for lintuzumab.

13 Sep 2010

Diamyd Medical reports potential results on NP2 Phase I clinical trial for chronic pain

Diamyd Medical AB, to date no drug related Serious Adverse Events have been reported by any patient included in Diamyd's Phase I clinical trial investigating NP2 as a potential therapy for chronic pain. Based upon the Phase I findings to date, the company is planning a multi-center, randomized, double-blind, placebo controlled Phase II clinical trial with NP2 in the United States.

13 Sep 2010

CRT agrees with AstraZeneca for AZD-3965 clinical trial

Cancer Research UK and Cancer Research Technology the charity's development and commercialisation arm have reached an agreement with AstraZeneca to take compound AZD-3965 a first-of-its-kind experimental drug to potentially treat a range of cancers into clinical trial.

13 Sep 2010

FDA approves CorMatrix ECM for Pericardial Closure

CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.

13 Sep 2010

NanoBio Corporation to present Nanoemulsion Phase I clinical trial data at ICAAC Conference

NanoBio Corporation today announced it will present data from two separate Phase 1 clinical trials at the 2010 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), taking place in Boston, Mass. from Sept. 12-15.

13 Sep 2010

Johns Hopkins added as second clinical trial site in Tengion Neo-Urinary Conduit Phase I clinical trial

Tengion, Inc., a leader in regenerative medicine, announced today it has added The Johns Hopkins Hospital in Baltimore, Maryland as a second clinical trial site for its Phase I clinical trial of the Company's lead product candidate, the Tengion Neo-Urinary Conduit™, in bladder cancer patients requiring bladder removal.

10 Sep 2010

Resverlogix announces key changes to Phase 2 ASSURE trial

Resverlogix Corp. announces that the Company's Phase 2 clinical trial, called ASSURE (ApoA-1 Synthesis Stimulation in Acute Coronary Syndrome patients), has made important modifications to the design of the trial which have the potential to demonstrate a more powerful endpoint for the planning of future clinical trials for RVX-208.

10 Sep 2010

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, today announced financial results for its 2010 fiscal year ended June 30, 2010.

10 Sep 2010

VCU Pauley Heart Center to investigate portable, mechanical driver for powering artificial hearts

The Virginia Commonwealth University Medical Center is the lead institution in a national clinical trial of technology that will allow artificial heart patients to recuperate, rehabilitate and wait in the comfort of their own homes until a donor heart becomes available for transplant.

10 Sep 2010

Koronis Pharmaceuticals to present KP-1461 clinical trial data at ICAAC Conference

Koronis Pharmaceuticals, Inc., a biotechnology company focused on the development of antiviral therapeutics, today announced that clinical trial data demonstrating that the Company's lead HIV drug, KP-1461, resulted in increased HIV mutations consistent with the Viral Decay Acceleration mechanism will be featured in a late-breaker oral presentation by James Mullins, Ph.D., Professor of Microbiology and Medicine at the University of Washington, at the upcoming 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) taking place in Boston, MA.

10 Sep 2010

Avinger initiates enrollment in Wildcat Catheter trial for chronic total occlusions in femoropopliteal lesions

Avinger, Inc., a medical device company focused on the development of innovative devices to combat peripheral artery disease, announces the enrollment of the first patient in the CONNECT (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) clinical trial. The CONNECT trial is a prospective, multi-center, non-randomized study intended to evaluate the Wildcat Catheter's ability to cross chronic total occlusions in femoropopliteal lesions.

10 Sep 2010

Special journal issue highlights obsessive compulsive disorder and Tourette's disorder therapies

Pediatric onset obsessive compulsive disorder (OCD) and Tourette's disorder (TD) share similarities in their underlying genetic and environmental factors, psychiatric features, and treatment methods. Advances in understanding the neurobiological basis of these disorders and discovering new and more effective therapies are highlighted in a special issue on OCD and TD in Journal of Child and Adolescent Psychopharmacology, a peer-reviewed journal published by Mary Ann Liebert, Inc.

10 Sep 2010

Clinical Trial News and Research

North Mississippi IRB approves CEL-SCI's Multikine Phase III clinical trial for head and neck cancer

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

Relypsa completes $70M Series B financing

Jennerex reports positive interim data from trial of JX-594 and sorafenib for liver cancer

Pro-Pharmaceuticals engages Numoda Corporation to optimize DAVANAT Phase III clinical trial

ARIAD commences ponatinib Phase 2 clinical trial in Ph+ ALL and chronic myeloid leukemia

XenoPort intends to initiate Phase 3 XP19986 trial for multiple sclerosis

Cyclacel reaches SPA agreement with FDA for sapacitabine Phase 3 trial in AML

Seattle Genetics' lintuzumab phase IIb clinical trial for AML does not meet primary endpoint

Diamyd Medical reports potential results on NP2 Phase I clinical trial for chronic pain

CRT agrees with AstraZeneca for AZD-3965 clinical trial

FDA approves CorMatrix ECM for Pericardial Closure

NanoBio Corporation to present Nanoemulsion Phase I clinical trial data at ICAAC Conference

Johns Hopkins added as second clinical trial site in Tengion Neo-Urinary Conduit Phase I clinical trial

Resverlogix announces key changes to Phase 2 ASSURE trial

Bioniche reduces net loss per share from $0.15 in fiscal 2009 to $0.02 in fiscal 2010

VCU Pauley Heart Center to investigate portable, mechanical driver for powering artificial hearts

Koronis Pharmaceuticals to present KP-1461 clinical trial data at ICAAC Conference

Avinger initiates enrollment in Wildcat Catheter trial for chronic total occlusions in femoropopliteal lesions

Special journal issue highlights obsessive compulsive disorder and Tourette's disorder therapies

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