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GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson's Disease (PD), is currently in Phase III clinical trials.

17 Dec 2010

FDA approves Neuralstem's IND to initiate NSI-189 Phase Ia safety trial in major depression

Neuralstem, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase Ia safety trial to test NSI-189, its first small molecule compound, in major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression and other diseases, such as Alzheimer's disease.

17 Dec 2010

Recordati, Nymox sign European licensing agreement for BPH investigational drug, NX-1207

Recordati and Nymox Pharmaceutical Corporation announced today the signing of a European licensing agreement for the development and commercialization of NX-1207, Nymox's Phase III investigational drug currently in clinical development in the U.S. for the treatment of benign prostatic hyperplasia (BPH).

17 Dec 2010

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Novavax, Inc. announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.

16 Dec 2010

Anacor Pharmaceuticals initiates AN2690 phase 3 program for onychomycosis fungal infection

Anacor Pharmaceuticals announced today that enrollment has been initiated and the first patient has been dosed in the Phase 3 program of AN2690, a topical antifungal product candidate for the treatment of onychomycosis.

16 Dec 2010

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

Drug Trial News

GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

FDA approves Neuralstem's IND to initiate NSI-189 Phase Ia safety trial in major depression

Recordati, Nymox sign European licensing agreement for BPH investigational drug, NX-1207

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Anacor Pharmaceuticals initiates AN2690 phase 3 program for onychomycosis fungal infection

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

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