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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

Ticagrelor exhibits potential for prevention of heart attacks

New findings from a major drug trial have brought experts a step closer to developing a drug which could prevent thousands of British deaths from heart attacks.

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

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

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

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

Vical's TransVax CMV vaccine achieves key endpoints in Phase 2 trial in immunocompromised HCT recipients

Vical Incorporated announced today the achievement of key efficacy, immunogenicity and safety results in a Phase 2 trial, establishing its TransVax™ cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients, and defining a potential pathway for further development.

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

Inovio Pharmaceuticals achieves promising results in VGX-3100 Phase I study

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved best-in-class immune responses in its Phase I dose escalation study of VGX-3100, its DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by human papillomavirus (HPV) types 16 and 18.

13 Sep 2010

Genmab announces Phase II ofatumumab study results in RRMS patients

Genmab A/S announced today encouraging results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS).

13 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

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., today announced that it has unblinded the Phase 3 study of abiraterone acetate plus prednisone for the treatment of patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer) whose disease has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.

10 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

FerroKin BioSciences initiates international Phase 2 study of FBS0701

FerroKin BioSciences today announced the initiation of an international Phase 2 study of FBS0701, a novel once-daily iron chelator in development for the treatment of transfusional iron overload. The Phase 2 study will assess the safety, tolerability, and pharmacodynamics of FBS0701.

10 Sep 2010

Allos Therapeutics to present FOLOTYN trial results at ESMO Congress

Allos Therapeutics, Inc. today announced that results from the Phase 2b investigational trial of FOLOTYN (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) will be presented at the 35th European Society of Medical Oncology (ESMO) Congress

10 Sep 2010

Drug Trial News

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

Ticagrelor exhibits potential for prevention of heart attacks

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

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

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

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

Vical's TransVax CMV vaccine achieves key endpoints in Phase 2 trial in immunocompromised HCT recipients

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

Inovio Pharmaceuticals achieves promising results in VGX-3100 Phase I study

Genmab announces Phase II ofatumumab study results in RRMS patients

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

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

FerroKin BioSciences initiates international Phase 2 study of FBS0701

Allos Therapeutics to present FOLOTYN trial results at ESMO Congress

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