Clinical Trial News and Research

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RV262 Phase I study launched to evaluate DNA prime/MVA vector boost vaccine regimen for HIV

A Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost vaccine regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa and South America.

29 Sep 2010

HUYA, Quintiles announce agreement to develop HBI-8000 cancer drug

HUYA Bioscience International, the leader in U.S.-China pharmaceutical co-development, and Quintiles, the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, today announced an agreement to co-develop a new cancer drug, HBI-8000, sourced in China by HUYA.

29 Sep 2010

PolyMedix begins PMX-30063 Phase 2 clinical trial for bacterial infections

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 2 clinical trial in Canada with its novel defensin-mimetic antibiotic, PMX-30063.

28 Sep 2010

Endo Pharmaceuticals to acquire Qualitest Pharmaceuticals

Apax Partners today announced that Endo Pharmaceuticals has entered into a definitive agreement to acquire Qualitest Pharmaceuticals for approximately $1.2 billion in cash. Qualitest, a portfolio company of Apax Partners since 2007, is the sixth largest generic pharmaceutical company in the U.S.

28 Sep 2010

Neuronix to present TMS treatment trial data for Alzheimer's disease at Geneva Congress

The results of a successful clinical trial using Neuronix Ltd., a developer of a patent-pending, non-invasive system for Alzheimer's Disease and related conditions, will be presented for the first time today at the annual Congress of the European Federation of Neurological Societies in Geneva, Switzerland.

28 Sep 2010

Researchers find genetic variants that cause arthritis in breast cancer patients taking aromatase inhibitors

Mayo Clinic researchers and their international colleagues have discovered genetic variants that lead to severe arthritis for a subset of women when taking aromatase inhibitors to treat their breast cancer. This serious side effect is so painful that many women halt their lifesaving medication. The findings appear today in the online issue of Journal of Clinical Oncology.

28 Sep 2010

Galapagos initiates phase II clinical study of GLPG0259 drug in RA patients

Galapagos NV announced today that it has started a Phase II clinical study for the Company's flagship program GLPG0259, a novel drug being developed for rheumatoid arthritis. In this clinical trial, the safety and efficacy of this novel candidate drug will be tested in RA patients. Galapagos plans to announce interim results by the middle of next year and complete the trial by the end of 2011.

28 Sep 2010

S*BIO initiates SB939 Phase 2 clinical trial for metastatic prostate cancer

S*BIO Pte Ltd today announced the initiation of a Phase 2 clinical trial of SB939, its novel orally-active HDAC inhibitor, in patients with recurrent or metastatic prostate cancer (HRPC).

27 Sep 2010

MediciNova receives FDA approval to proceed with initial trial of ibudilast

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported FDA's approval to proceed with an initial trial of the company's neurological drug candidate, ibudilast (MN-166/AV411), as a potential new pharmacotherapy for methamphetamine addiction.

27 Sep 2010

Takeda announces SGN-35 ADC trial results in Hodgkin lymphoma patients

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top line results from the pivotal trial of single agent brentuximab vedotin (SGN-35), an antibody drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.

27 Sep 2010

Clinical trial results of Genous Bio-engineered R stent, EPC capture technology presented at TCT 2010

OrbusNeich today announced that clinical trial results highlighting the company's Genous Bio-engineered R stent and its endothelial progenitor cell capture technology across challenging patient subsets were presented during a symposium titled "EPC Capture Technology: from Genous to Combo" at Transcatheter Cardiovascular Therapeutics 2010 in Washington.

27 Sep 2010

Researchers synthesize molecule to block abnormal protein in cancer cells

In the quest to arrest the growth and spread of tumors, there have been many attempts to get cancer genes to ignore their internal instruction manual. In a new study, a team led by Dana-Farber Cancer Institute scientists has created the first molecule able to prevent cancer genes from "hearing" those instructions, stifling the cancer process at its root.

27 Sep 2010

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

24 Sep 2010

Cook Medical submits PMA to FDA for new balloon expandable stent for renal artery disease

Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its new balloon expandable stent for renal artery disease. Intended for patients suffering from renal artery stenosis, a narrowing of the arteries that supply blood to the kidneys, the new device features a low profile design and does not shorten upon expansion.

24 Sep 2010

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Enobia Pharma today announced positive results for its Phase II juvenile clinical trial of ENB-0040 (asfotase alfa), an experimental bone-targeted enzyme replacement therapy intended for the treatment of hypophosphatasia (HPP). Hypophosphatasia is a rare, inherited, and sometimes fatal metabolic bone disease that affects individuals of all ages.

24 Sep 2010

Vical prices underwritten common stock public offering

Vical Incorporated today announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a price to the public of $2.25 per share. The gross proceeds to us from this offering are expected to be approximately $33.8 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering is expected to close on or about September 29, 2010, subject to customary closing conditions.

24 Sep 2010

Cylene commences CX-4945 Phase I trial in multiple myeloma

Cylene Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of their first-in-class, oral CK2 inhibitor CX-4945 in patients with multiple myeloma. Cylene also announced the simultaneous closing of a $12 million financing with participation from existing investors including Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd.

24 Sep 2010

OrbusNeich completes enrollment in Combo Bio-engineered Sirolimus Eluting Stent clinical trial

OrbusNeich today announced at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington the completion of patient enrollment in the randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) with 183 patients included at sites in Asia, Australia, Europe and South America.

24 Sep 2010

NSBRI project to develop LTM/iRevive system for astronauts’ medical care

On an exploration mission, an astronaut has an accident and appears to have serious injuries as the spacecraft speeds to its destination. The ensuing scene is hectic as the other crew members try to get a grasp on the situation and provide appropriate treatment. Efficient use of time and resources may be the difference between life and death.

24 Sep 2010

Legislation to help speed research for cystic fibrosis and other rare diseases

Today the U.S. House of Representatives passed the "Improving Access to Clinical Trials Act" (I-ACT), in a victory for the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

24 Sep 2010

Clinical Trial News and Research

RV262 Phase I study launched to evaluate DNA prime/MVA vector boost vaccine regimen for HIV

HUYA, Quintiles announce agreement to develop HBI-8000 cancer drug

PolyMedix begins PMX-30063 Phase 2 clinical trial for bacterial infections

Endo Pharmaceuticals to acquire Qualitest Pharmaceuticals

Neuronix to present TMS treatment trial data for Alzheimer's disease at Geneva Congress

Researchers find genetic variants that cause arthritis in breast cancer patients taking aromatase inhibitors

Galapagos initiates phase II clinical study of GLPG0259 drug in RA patients

S*BIO initiates SB939 Phase 2 clinical trial for metastatic prostate cancer

MediciNova receives FDA approval to proceed with initial trial of ibudilast

Takeda announces SGN-35 ADC trial results in Hodgkin lymphoma patients

Clinical trial results of Genous Bio-engineered R stent, EPC capture technology presented at TCT 2010

Researchers synthesize molecule to block abnormal protein in cancer cells

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Cook Medical submits PMA to FDA for new balloon expandable stent for renal artery disease

Enobia announces positive results from ENB-0040 Phase II juvenile clinical trial for hypophosphatasia

Vical prices underwritten common stock public offering

Cylene commences CX-4945 Phase I trial in multiple myeloma

OrbusNeich completes enrollment in Combo Bio-engineered Sirolimus Eluting Stent clinical trial

NSBRI project to develop LTM/iRevive system for astronauts’ medical care

Legislation to help speed research for cystic fibrosis and other rare diseases

Achieving and maintaining ISO 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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