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Update on Phase II clinical study of CH-4051 in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced that during a teleconference yesterday, the U.S. Food and Drug Administration requested that the company delay the initiation of its proposed Phase II clinical study of CH-4051 in rheumatoid arthritis and indicated that the agency is requesting additional detail from the preclinical studies previously submitted as part of the company's investigational new drug application.

9 Jun 2010

Human Genome Sciences reports results of mapatumumab Phase 2 trial for multiple myeloma

Human Genome Sciences, Inc. today announced the results of its randomized Phase 2 trial of mapatumumab (HGS-ETR1) in combination with bortezomib (Velcade) in patients with advanced multiple myeloma.

9 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic liver failure

Vital Therapies, Inc., (VTI) is pleased to announce that the first two subjects have been enrolled at King's College Hospital in London in the expansion of its SILVER (Stabilization In LiVER failure) clinical trial in Europe. The trial is evaluating whether VTI's biological cellular therapy product, ELAD®, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure (ACLF).

9 Jun 2010

Phase 3 clinical study: Ipilimumab boosts, sustains immune system responses against melanoma tumors

The Cancer Research Institute, a nonprofit organization dedicated to the development of immune system-based treatments for cancer, announced today its celebration of a significant new breakthrough in the treatment of melanoma, the deadliest form of skin cancer. The new treatment, a cancer immunotherapy created by Cancer Research Institute Scientific Advisory Council Associate Director James P. Allison, Ph.D., is designed to "take the brakes off the immune system," and is the first treatment ever proven to extend life for patients whose melanomas are unresponsive to existing cancer therapies.

9 Jun 2010

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Millennium: The Takeda Oncology Company today announced data from clinical trials of four investigational compounds in solid tumors presented at the Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois, June 4-8, 2010. These data include an oral presentation on MLN8237, the Company's selective Aurora A kinase inhibitor.

9 Jun 2010

Lantheus Medical Imaging reports Phase 1 data of LMI 1195 heart failure PET imaging agent

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced Phase 1 data for its novel heart failure Positron Emission Tomography (PET) imaging agent, LMI 1195, which is in development for the evaluation of patients at risk of heart failure or sudden cardiac death.

9 Jun 2010

$Pivotal trial data of zalutumumab in refractory head and neck cancer patients presented at ASCO 2010$

Pivotal trial data of zalutumumab in refractory head and neck cancer patients presented at ASCO 2010

Genmab A/S announced today that data from the pivotal trial of zalutumumab in refractory head and neck cancer patients will be presented today at the 2010 American Society of Clinical Oncology Annual Meeting, which will be held June 1-8 in Chicago, Illinois. This is the first controlled study to demonstrate that an EGFr-targeted antibody given as monotherapy induces a clinically meaningful improvement in progression free survival in patients with refractory head and neck cancer who have failed platinum-based chemotherapy.

9 Jun 2010

GE Healthcare to present anti-[18F]FACBC phase 1 study results at Society of Nuclear Medicine annual meeting

GE Healthcare, a unit of the General Electric Company, today will present results of a phase 1 study of anti-[18F]FACBC at the 57th annual meeting of the Society of Nuclear Medicine in Salt Lake City, Utah. The presentation closely follows the launch of the phase 2 clinical development program for anti-[18F]FACBC, which was initially discovered and developed by Emory University, Atlanta, Georgia, and was licensed to Nihon Medi-Physics Co., Ltd. (NMP) of Japan.

9 Jun 2010

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p<0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain's sleep-wake process.

9 Jun 2010

Pharnext closes €4.8-million Series A funding round

Pharnext SAS, a biopharmaceutical company specializing in the development of innovative treatments based on Pleotherapy™ for severe neurological diseases, today announced that it had closed a €4.8-million Series A round of funding on June 3rd (corresponding to a company valuation of €45 million).

9 Jun 2010

Lytix Biopharma, KAEL-GemVax granted approval for GV1001/LTX-315 combination cancer therapy study

The Norwegian biopharmaceutical company Lytix Biopharma and Korean company KAEL-GemVax today announced approval by the Norwegian Medicines Agency ('Statens Legemiddelverk') to test a combination of LTX-315 and GV1001 as vaccine therapy in patients with resected tumours. Lytix Biopharma CEO Gunnar Salid states, "We are delighted to announce the approval of our joint study to test a combination of two very interesting experimental drugs.

9 Jun 2010

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Helix BioPharma Corp. today announced results from the Phase II clinical trial assessing the efficacy and safety of Topical Interferon Alpha-2b cream for the treatment of ano-genital warts (AGW).

9 Jun 2010

PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

PharmaMar SA today announced that a registration trial in relapsed/refractory multiple myeloma patients has been initiated with Aplidin(R) (plitidepsin) in combination with dexamethasone versus dexamethasone alone.

9 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010

Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

Argos Therapeutics today announced the presentation of positive interim data from a Phase 2 trial that evaluated the clinical activity, safety and immune response of AGS-003 treatment, given in combination with sunitinib, in patients with newly diagnosed advanced renal cell carcinoma (RCC). The data were discussed June 7 in a poster session at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago, IL.

8 Jun 2010

NanoViricides anti-HIV drug candidates demonstrate efficacy in cell culture studies with HIV-1 isolates

NanoViricides, Inc. reports that its anti-HIV drug candidates demonstrated efficacy in the recently completed cell culture studies using two distinctly different HIV-1 isolates. The studies were performed in the laboratory of Carol Lackman-Smith at the Southern Research Institute, Frederick, Maryland.

8 Jun 2010

Immunomedics reports encouraging results from TF2 Phase I studies for colorectal cancer

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported that TF2, a proprietary bispecific antibody, has shown selective tumor localization and minimal normal tissue retention in two early Phase I studies in patients with colorectal cancer.

8 Jun 2010

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Aerovance Inc. today announced top-line results from its Phase 2b clinical trial that show the inhaled dry powder formulation of Aerovant (pitrakinra inhalation powder) is effective in a pre-defined subset of patients with eosinophilic asthma.

8 Jun 2010

GTx reports positive results from toremifene Phase III clinical trial

GTx, Inc. announced today that in the Phase III clinical trial evaluating toremifene 80 mg for the reduction of fractures and treatment of other estrogen deficiency side effects in men with prostate cancer on androgen deprivation therapy (ADT), toremifene treatment demonstrated an improved benefit/risk ratio in men less than 80 years of age. The data were presented yesterday at the 2010 Annual Meeting of the American Society of Clinical Oncology in Chicago.

8 Jun 2010

Drug Trial News

Update on Phase II clinical study of CH-4051 in rheumatoid arthritis

Human Genome Sciences reports results of mapatumumab Phase 2 trial for multiple myeloma

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic liver failure

Phase 3 clinical study: Ipilimumab boosts, sustains immune system responses against melanoma tumors

Clinical trials of four investigational compounds in solid tumors presented at ASCO Annual Meeting

Lantheus Medical Imaging reports Phase 1 data of LMI 1195 heart failure PET imaging agent

Pivotal trial data of zalutumumab in refractory head and neck cancer patients presented at ASCO 2010

GE Healthcare to present anti-[18F]FACBC phase 1 study results at Society of Nuclear Medicine annual meeting

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Pharnext closes €4.8-million Series A funding round

Lytix Biopharma, KAEL-GemVax granted approval for GV1001/LTX-315 combination cancer therapy study

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

NanoViricides anti-HIV drug candidates demonstrate efficacy in cell culture studies with HIV-1 isolates

Immunomedics reports encouraging results from TF2 Phase I studies for colorectal cancer

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

GTx reports positive results from toremifene Phase III clinical trial

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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