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Ascenta, LLS enter agreement to develop AT-406 IAP small molecule inhibitor for acute myeloid leukemia

Ascenta Therapeutics, Inc. and The Leukemia & Lymphoma Society (LLS) today entered into an agreement whereby the LLS will support clinical development of Ascenta's oral small molecule inhibitor of IAPs (inhibitor of apoptosis proteins), AT-406, for patients with acute myeloid leukemia (AML).

7 Dec 2010

Sequella files SQ109 IND for Phase 2 studies in H. pylori-related duodenal ulcers

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of infectious diseases, announced it has successfully filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) to test SQ109 in patients suffering from H. pylori-related duodenal ulcers, and can now begin Phase 2 studies.

7 Dec 2010

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

Independent investigators reported today that patients with paroxysmal nocturnal hemoglobinuria who were treated long-term with Soliris (eculizumab) achieved survival comparable to that of an age- and gender-matched normal population. Findings from this investigator-led analysis were reported in an oral presentation today at the 52nd American Society of Hematology Annual Meeting and Exposition in Orlando.

7 Dec 2010

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA® (abatacept), a treatment for adult patients with moderate to severe rheumatoid arthritis (RA) administered through an injection into the skin. Bristol-Myers Squibb submitted the sBLA to the FDA for the subcutaneous formulation of ORENCIA and received confirmation of its receipt on October 4, 2010.

7 Dec 2010

VIVUS reports positive results from avanafil phase 3 study in erectile dysfunction

VIVUS, Inc. today announced positive results from TA-314, a phase 3 pivotal open-label safety study of avanafil, an investigational drug for the treatment of erectile dysfunction (ED). The study met all primary endpoints by demonstrating improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF).

7 Dec 2010

GeoVax expands Phase 2a clinical trial for MVA62B HIV/AIDS vaccine

GeoVax Labs, Inc., announced today the expansion of the Phase 2a clinical trial testing of its HIV/AIDS vaccine products. The expanded Phase 2a trial will test the administration of three doses of the recombinant poxvirus vaccine MVA62B without the use of the recombinant DNA-vectored vaccine, which was used to prime immune responses in the first part of this trial.

7 Dec 2010

No evidence of toxicity in hemophilia B patients enrolled in gene therapy trial

Investigators report no evidence of toxicity in the four hemophilia B patients enrolled to date in a gene therapy trial using a vector under development at St. Jude Children's Research Hospital and UCL (University College London) to correct the inherited bleeding disorder.

7 Dec 2010

ArQule initiates enrollment in ARQ 736 Phase 1 clinical trial for advanced solid tumors

ArQule, Inc. today announced the commencement of patient dosing in a Phase 1 clinical trial with ARQ 736, a small molecule inhibitor of the RAF kinases.

7 Dec 2010

Achillion Pharmaceuticals to present clinical study data of ACH-1625 at APASL 2011

Achillion Pharmaceuticals, Inc. today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver to be held February 17-21, 2011 in Bangkok, Thailand.

6 Dec 2010

Preclinical data of ZIO-101 in various lymphoma models presented at ASH 2010

ZIOPHARM Oncology, Inc. announced today that new preclinical data on the novel mechanism of its organic arsenic darinaparsin (ZIO-101) in various lymphoma models were presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology in Orlando Florida.

6 Dec 2010

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today it has received approval from the Food and Drug Administration to proceed with the first human clinical trial of plant-produced H5N1 influenza vaccine.

6 Dec 2010

$Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL$

Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL

Allos Therapeutics, Inc. today reported new analysis of data from the Company's pivotal PROPEL trial of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida.

6 Dec 2010

Telik announces positive results from Phase 2 trial of ezatiostat in patients with MDS

Telik, Inc. today announced positive results from a Phase 2 multicenter trial of oral ezatiostat hydrochloride (TELINTRA, TLK199) in patients with an International Prognostic System Score of low to intermediate-1 risk myelodysplastic syndrome.

6 Dec 2010

$Updated Phase 1 study data of ponatinib in patients with refractory CML, Ph+ ALL presented at ASH$

Updated Phase 1 study data of ponatinib in patients with refractory CML, Ph+ ALL presented at ASH

ARIAD Pharmaceuticals, Inc. today announced updated clinical data from a fully enrolled and ongoing Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with resistant and refractory chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia.

6 Dec 2010

Genentech announces Phase II study results of RG1678 for treatment of schizophrenia

Genentech, Inc., a member of the Roche Group, today announced eight-week results from a Phase II study of RG1678, its investigational first-in-class glycine reuptake inhibitor for the treatment of schizophrenia.

6 Dec 2010

New research focusing on VTE presented at ASH Annual Meeting

The latest advances in the treatment of bleeding and clotting disorders will be presented today at the 52nd Annual Meeting of the American Society of Hematology, focusing on venous thrombeombolism, a potentially life-threatening disorder in which abnormal blood clots form in the veins and restrict the flow of blood. New studies examine risk-prediction models and cutting-edge treatment options for patients with VTE.

6 Dec 2010

Phase 1 clinical data: ARRY-520 shows positive preliminary results in treating multiple myeloma

Array BioPharma Inc. today announced the presentation of positive Phase 1 clinical data for its novel kinesin spindle protein inhibitor, ARRY-520. The data, which were presented at the 2010 Annual Meeting of the American Society of Hematology in Orlando, Florida, indicate that ARRY-520 was well tolerated and has shown encouraging preliminary results in the treatment of multiple myeloma.

6 Dec 2010

Research on BCR-ABL inhibitors for treating ALL, CML presented at ASH Annual Meeting

Over the past decade, significant advances have been made in the treatment of leukemia through the ongoing development of gene-based targeted therapies. Research that will be presented today at the 52nd Annual Meeting of the American Society of Hematology provides greater understanding of the optimal use of several BCR-ABL inhibitors for the treatment of acute lymphoblastic leukemia and chronic myeloid leukemia, and how a new gene target functions for several myeloid malignancies.

6 Dec 2010

Preclinical study results for Syk, JAK inhibitor program presented at ASH 2010

Portola Pharmaceuticals, Inc. today announced the presentation of preclinical study results for its novel Syk and JAK inhibitor program at the American Society of Hematology's 52nd Annual Meeting and Exposition. Portola's novel Syk and JAK inhibitors are in development to treat chronic inflammatory diseases, including rheumatoid arthritis, and certain cancers, including non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

6 Dec 2010

Cell Therapeutics announces new pixantrone EOS follow up results

Cell Therapeutics, Inc. today announced new pixantrone end of study follow up results from the Company's pivotal phase III PIX301 trial, which results form the basis for the Company's recent Marketing Authorization Application currently under review by the European Medicines Agency.

6 Dec 2010

Drug Trial News

Ascenta, LLS enter agreement to develop AT-406 IAP small molecule inhibitor for acute myeloid leukemia

Sequella files SQ109 IND for Phase 2 studies in H. pylori-related duodenal ulcers

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

FDA accepts for review Bristol-Myers Squibb's ORENCIA sBLA for severe RA

VIVUS reports positive results from avanafil phase 3 study in erectile dysfunction

GeoVax expands Phase 2a clinical trial for MVA62B HIV/AIDS vaccine

No evidence of toxicity in hemophilia B patients enrolled in gene therapy trial

ArQule initiates enrollment in ARQ 736 Phase 1 clinical trial for advanced solid tumors

Achillion Pharmaceuticals to present clinical study data of ACH-1625 at APASL 2011

Preclinical data of ZIO-101 in various lymphoma models presented at ASH 2010

Fraunhofer USA CMB receives FDA approval to initiate Phase I clinical trial of H5N1 influenza vaccine

Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL

Telik announces positive results from Phase 2 trial of ezatiostat in patients with MDS

Updated Phase 1 study data of ponatinib in patients with refractory CML, Ph+ ALL presented at ASH

Genentech announces Phase II study results of RG1678 for treatment of schizophrenia

New research focusing on VTE presented at ASH Annual Meeting

Phase 1 clinical data: ARRY-520 shows positive preliminary results in treating multiple myeloma

Research on BCR-ABL inhibitors for treating ALL, CML presented at ASH Annual Meeting

Preclinical study results for Syk, JAK inhibitor program presented at ASH 2010

Cell Therapeutics announces new pixantrone EOS follow up results

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