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Researchers begin placebo-controlled trial to test drug treatment for Rett syndrome

Researchers at Children's Hospital Boston have begun a randomized, placebo-controlled trial to test a potential drug treatment for Rett syndrome, the leading known genetic cause of autism in girls.

16 Dec 2010

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Manhattan Pharmaceuticals, Inc. announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.

16 Dec 2010

Amarin completes patient randomization in AMR101 Phase 3 trial in patients with high triglyceride levels

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported the completion of patient randomization for its ANCHOR trial, a pivotal Phase 3 trial of AMR101. The Company indicated that it anticipates reporting top-line results from this trial in Q2 2011.

16 Dec 2010

BELLUS Health, Celtic Therapeutics initiate KIACTA global confirmatory phase III clinical study for AA amyloidosis

BELLUS Health Inc. and Celtic Therapeutics announced today that a global confirmatory phase III clinical study was initiated on December 14, 2010 for KIACTA™ (eprodisate). KIACTA™ is a drug candidate being developed for the treatment of AA amyloidosis, a life-threatening orphan disease that occurs in patients with long-lasting inflammatory conditions, most commonly due to rheumatoid arthritis. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis.

16 Dec 2010

CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

CEL-SCI Corporation announced today it has received governmental approval from the Health Authority, Ministry of Health of Ukraine, to begin enrollment of subjects for a Phase III clinical trial of Multikine® in Ukraine. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Ukraine is one of nine countries to participate in this global Phase III trial. The Phase III trial will be run at about 48 clinical centers, of which about 6 centers will be in Ukraine.

16 Dec 2010

ADVENTRX seeks meeting with FDA to discuss ANX-514 docetaxel emulsion study findings

ADVENTRX Pharmaceuticals, Inc. today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.

16 Dec 2010

$Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea$

Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene, a bio-pharmaceutical company specialized in the development of immunotherapeutic products, today announced that enrollment and treatment of patients in a Phase 1b clinical trial has been initiated to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer (CRC).

16 Dec 2010

HealthLinx's OvPlex performs better over CA125 in part 1 of multinational ovarian cancer biomarker study

Diagnostic company HealthLinx Limited reports that initial analysis of part 1 of its multinational ovarian cancer biomarker study confirms a statistically significant increase in diagnostic performance of OvPlex™ over CA125 alone. Enhanced performance of OvPlex™ was also established specifically for early stage (Stage I-II) disease.

16 Dec 2010

Enzon in collaboration with NCI initiates EZN-2968, EZN-2208 Phase I studies for arresting tumor growth

Enzon Pharmaceuticals, today announced the initiation of Phase I clinical studies, in collaboration with the National Cancer Institute, for two of the Company's novel oncology product candidates, EZN-2968 and EZN-2208 (PEG-SN38).

16 Dec 2010

Ocera completes two studies of OCR-002 in patients with hyperammonemia, hepatic encephalopathy

Ocera Therapeutics, Inc. announced today that it has completed two studies evaluating the safety and pharmacokinetics of OCR-002 (ornithine phenylacetate) which includes healthy volunteers and patients with liver cirrhosis. OCR-002 recently received Orphan Drug status and Fast Track designation by the United States Food and Drug Administration for the treatment of hyperammonemia (excessive ammonia levels) and resultant Hepatic encephalopathy.

16 Dec 2010

Clinical Investigation – ground-breaking new launch from Future Science

In recognition of the methodology, progress and outcome of clinical trials, Future Science has announced the launch of the definitive title Clinical Investigation. The journal is the latest addition to the Future Science’s collection of titles addressing those areas that most impact our daily lives (available at www.future-science.com). Future Science is part of London-based Future Science Group.

15 Dec 2010

Targeting mutant BRAF can kill cancer cells, but cannot finish off melanoma

This past summer saw a revolution in melanoma therapy. Patients whose melanoma lesions contain a mutation in the BRAF gene were successfully treated with a BRAF-specific inhibitor, PLX4032. Reports of the drug trial described shrinking tumors and improved health. Yet seven months after therapy began the tumors returned and resumed growing. Now, scientists at The Wistar Institute explain why: the tumor learns to signal around the blocked gene by adjusting its molecular wiring.

15 Dec 2010

Charité begins implementation of MGN1601 clinical phase I/II study in renal cancer

The Charité - Medical University of Berlin has today begun the implementation of the clinical study phase I/II with the renal cancer medication MGN1601 (ASET Study). With this MOLOGEN AG product, an innovative cell-based gene therapy for the treatment of advanced renal cancer is entering the first important test phase.

15 Dec 2010

Profectus' GENEVAX IL-12 pDNA adjuvant improves vaccine-induced response rate in Phase I HIV study

Profectus Biosciences, Inc., a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, announced today that its GENEVAX™ IL-12 pDNA adjuvant has significantly improved the vaccine-induced response rate in a Phase I clinical study of an experimental DNA vaccine for the prevention of HIV infection.

15 Dec 2010

Researchers introduce new class of drugs for HCV patients

To improve the care for individuals infected with the hepatitis C virus, a major health problem and a leading cause of chronic liver disease around the world, nearly 200 international hepatitis experts have taken an important step in escalating the introduction of a new class of targeted therapies for HCV – direct-acting antivirals.

15 Dec 2010

MHRA issues notice of acceptance for BioMarin's GALNS Phase 3 trial in MPS IVA

BioMarin Pharmaceutical Inc. today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has completed review of the Clinical Trial Application (CTA) and issued a notice of acceptance for the Phase 3 trial of N-acetylgalactosamine 6-sulfatase (GALNS) for the treatment of Mucopolysaccharidosis IVA (MPS IVA). The company expects to initiate the Phase 3 pivotal trial early in the first quarter of 2011.

15 Dec 2010

Positive results from Creabilis CT327 Phase IIa study in atopic dermatitis

Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, announced positive results in the Phase IIa study of its lead product CT327 in atopic dermatitis.

15 Dec 2010

Ipsen discontinues development of chimeric compound BIM 23A760 for acromegaly

Ipsen announced today that the preliminary data from the ongoing phase IIb study in patients with acromegaly for its chimeric compound BIM 23A760 does not meet the expected inhibition of growth hormone (GH) and IGF-1 levels after repeat dosing. Preliminary phase IIb data showed a strong dopaminergic activity but only weak evidence of somatostatinergic activity.

15 Dec 2010

Myotec, Hybrid merge to form PsiOxus Therapeutics

Myotec Therapeutics, Ltd. and Hybrid BioSystems, Ltd. today announced their merger to form PsiOxus Therapeutics, Ltd. (PsiOxus), a new, development stage biotechnology company using non-traditional approaches to novel therapeutics for cancer and wasting diseases. PsiOxus, which will be led by CEO Dr. John Beadle, boasts a combined pipeline of phase I and II clinical stage assets.

15 Dec 2010

NCI initiates crolibulin/cisplatin combination Phase II trial in anaplastic thyroid cancer

EpiCept Corporation today announced that the National Cancer Institute (NCI) has initiated a Phase II trial with crolibulinTM (EPC2407). The trial will assess the drug's efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (ATC). CrolibulinTM is a vascular disruption and apoptosis inducing agent that has demonstrated potent anti-tumor activity in both preclinical and early clinical studies.

15 Dec 2010

Drug Trial News

Researchers begin placebo-controlled trial to test drug treatment for Rett syndrome

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Amarin completes patient randomization in AMR101 Phase 3 trial in patients with high triglyceride levels

BELLUS Health, Celtic Therapeutics initiate KIACTA global confirmatory phase III clinical study for AA amyloidosis

CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

ADVENTRX seeks meeting with FDA to discuss ANX-514 docetaxel emulsion study findings

Phase 1b clinical trial of JX-594 in metastatic, refractory colorectal cancer commences in Korea

HealthLinx's OvPlex performs better over CA125 in part 1 of multinational ovarian cancer biomarker study

Enzon in collaboration with NCI initiates EZN-2968, EZN-2208 Phase I studies for arresting tumor growth

Ocera completes two studies of OCR-002 in patients with hyperammonemia, hepatic encephalopathy

Clinical Investigation – ground-breaking new launch from Future Science

Targeting mutant BRAF can kill cancer cells, but cannot finish off melanoma

Charité begins implementation of MGN1601 clinical phase I/II study in renal cancer

Profectus' GENEVAX IL-12 pDNA adjuvant improves vaccine-induced response rate in Phase I HIV study

Researchers introduce new class of drugs for HCV patients

MHRA issues notice of acceptance for BioMarin's GALNS Phase 3 trial in MPS IVA

Positive results from Creabilis CT327 Phase IIa study in atopic dermatitis

Ipsen discontinues development of chimeric compound BIM 23A760 for acromegaly

Myotec, Hybrid merge to form PsiOxus Therapeutics

NCI initiates crolibulin/cisplatin combination Phase II trial in anaplastic thyroid cancer

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