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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

Phase 3 clinical study demonstrates efficacy of metformin therapy in type 2 diabetes

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone.

24 Sep 2010

Biothera receives SBIR award to evaluate therapeutic potential of Imprime PGG drug in pancreatic cancer

Biothera has received a National Cancer Institute SBIR award to evaluate the therapeutic potential of its drug candidate Imprime PGG in pancreatic cancer, the company announced today.

24 Sep 2010

Tolerx presents otelixizumab preclinical research at 46th EASD

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, today announced the presentation of preclinical research describing the mechanism of action of otelixizumab at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD). In addition, Tolerx also announced that the first European patient was enrolled in DEFEND-2, a confirmatory Phase 3 clinical trial evaluating otelixizumab in autoimmune new-onset type 1 diabetes.

23 Sep 2010

FDA grants ZIOPHARM's darinaparsin Orphan Drug Designation for peripheral T-cell Lymphoma treatment

ZIOPHARM Oncology, Inc. announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to darinaparsin (Zinapar™ or ZIO-101) for the treatment of peripheral T-cell Lymphoma (PTCL). The United States Orphan Drug Act of 1983 was created to provide incentives for companies to develop and market treatments for diseases or conditions affecting fewer than 200,000 people in the United States.

23 Sep 2010

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

New data from the linagliptin late stage clinical trial programme were presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD).

23 Sep 2010

Athersys presents MultiStem phase I study results at TCT Conference

Athersys, Inc. announced at its presentation at the Transvascular Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C., updated results from its phase I clinical trial of MultiStem, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI).

23 Sep 2010

Vaxonco initiates Phase I clinical trial of novel DNA-based polyepitope vaccine against malaria

Vaxonco Inc., a Korean company specializing in peptide-based vaccines and Ichor Medical Systems (Ichor), whose advanced TriGrid™ Delivery System (TriGrid™) is being tested worldwide for its ability to enhance delivery of DNA drugs and vaccines, announced today the initiation of a Phase I clinical trial to evaluate a novel DNA-based polyepitope vaccine against malaria.

23 Sep 2010

Phase II study: Fostamatinib improves outcomes in RA patients

AstraZeneca's new oral syk inhibitor, fostamatinib (R788), recently in-licensed from Rigel Pharmaceuticals, Inc., significantly improved outcomes of patients with rheumatoid arthritis who responded inadequately to ongoing treatment with methotrexate, according to phase II study data published in The New England Journal of Medicine today.

23 Sep 2010

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

23 Sep 2010

DSMB authorizes Oxygen Biotherapeutics' next cohort of Oxycyte emulsion study in severe non-penetrating TBI

Oxygen Biotherapeutics, Inc. reported today that the Data Safety Monitoring Board overseeing the company's ongoing Phase II-b trial has, based on the results of the first cohort of patients, authorized the company to move forward with the next cohort of the study. This trial is a randomized, single-dose, placebo-controlled, double-blind, dose-escalation study to evaluate the safety and tolerability of our Oxycyte® emulsion in patients with severe non-penetrating traumatic brain injury.

23 Sep 2010

Infinity Pharmaceuticals to present IPI-926 inhibitor Phase 1 data at ESMO Congress

Infinity Pharmaceuticals, Inc. today announced that Phase 1 data of its novel Hedgehog pathway inhibitor, IPI-926, will be presented during the 35th Congress of the European Society of Molecular Oncology (ESMO), in Milan, Italy.

23 Sep 2010

Weight-based taribavirin reduces anemia, increases sustained virologic response

Researchers at Cedars-Sinai Medical Center and 50 other centers found that weight-based dosing of taribavirin reduces rates of anemia while increasing sustained virologic response (SVR) in patients with chronic hepatitis C (HCV). Full details of this study are available in the October issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

23 Sep 2010

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Intarcia Therapeutics, Inc. presented today final results of a 24-week phase 2 clinical study of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.

23 Sep 2010

Boehringer Ingelheim to present linagliptin Phase III data at 46th EASD

New Phase III data found that investigational linagliptin therapy resulted in significant reductions in blood sugar as measured by hemoglobin A1c (HbA1c) when compared to placebo, both when added to sulfonylurea (SU) in inadequately controlled type 2 diabetes (T2D) patients, and when administered as monotherapy in T2D patients for whom metformin is inappropriate.

22 Sep 2010

Titan completes enrollment in Probuphine Phase 3 study for opioid addiction

Titan Pharmaceuticals, Inc. today announced that patient enrollment is now complete in the confirmatory, Phase 3 clinical study of Probuphine for the treatment of opioid addiction. This placebo and active controlled Phase 3 study is being conducted at 20 sites in the United States and the results are expected in the second quarter of 2011, about three months ahead of the original schedule.

22 Sep 2010

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus.

22 Sep 2010

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

OncoGenex Pharmaceuticals, Inc. announced today publication of results from a randomized Phase 2 trial in the Journal of Clinical Oncology. The trial results showed a survival benefit with the investigational agent OGX-011/TV1011 (custirsen) in patients with advanced prostate cancer. The median overall survival for patients who were treated with custirsen plus first-line docetaxel/prednisone was 23.8 months compared to 16.9 months for patients treated with docetaxel/prednisone alone.

22 Sep 2010

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Celsion Corporation announced today that an abstract on its Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall Breast Cancer has been accepted for a poster session at the 2010 Breast Cancer Symposium. The abstract will provide updated clinical results, as well as the rationale and design of the DIGNITY study, which is evaluating ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer.

22 Sep 2010

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Progenics Pharmaceuticals, Inc. today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC).

22 Sep 2010

Drug Trial News

Cylene commences CX-4945 Phase I trial in multiple myeloma

Phase 3 clinical study demonstrates efficacy of metformin therapy in type 2 diabetes

Biothera receives SBIR award to evaluate therapeutic potential of Imprime PGG drug in pancreatic cancer

Tolerx presents otelixizumab preclinical research at 46th EASD

FDA grants ZIOPHARM's darinaparsin Orphan Drug Designation for peripheral T-cell Lymphoma treatment

Linagliptin clinical trial data shows positive result for type 2 diabetes treatment

Athersys presents MultiStem phase I study results at TCT Conference

Vaxonco initiates Phase I clinical trial of novel DNA-based polyepitope vaccine against malaria

Phase II study: Fostamatinib improves outcomes in RA patients

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

DSMB authorizes Oxygen Biotherapeutics' next cohort of Oxycyte emulsion study in severe non-penetrating TBI

Infinity Pharmaceuticals to present IPI-926 inhibitor Phase 1 data at ESMO Congress

Weight-based taribavirin reduces anemia, increases sustained virologic response

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Boehringer Ingelheim to present linagliptin Phase III data at 46th EASD

Titan completes enrollment in Probuphine Phase 3 study for opioid addiction

Santaris Pharma paves way to conduct clinical trial of miravirsen in patients with HVC

Results of custirsen Phase 2 trial for advanced prostate cancer published in Journal of Clinical Oncology

Phase I/II DIGNITY trial abstract of ThermoDox accepted for poster session at 2010 Breast Cancer Symposium

Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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