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Access Pharmaceuticals initiates Phase I/II dose escalating study for Thiarabine

Access Pharmaceuticals, Inc., today announced it has initiated a Phase I/II dose-escalating study of its proprietary, anti-cancer drug, Thiarabine, a nucleoside analog for patients with hematologic malignancies (cancers of the blood). The primary objective of the study is to determine the maximum tolerated dose (MTD) in two different dosing schedules with various leukemias and lymphomas and recommended Phase II dose. The program is being led by Hagop Kantarjian, M.D., Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas.

4 Aug 2010

Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

Advaxis, Inc.,, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has received formal permission from the Drugs Controller General India (DCGI) to conduct a Phase II clinical trial of ADXS11-001, the Company's flagship drug construct, among 110 women with advanced, metastatic cervical cancer that has progressed subsequent to treatment with cytotoxic therapy. 55 women will receive ADXS11-001 alone, 55 will receive a combined regimen of both ADXS11-001 and cytotoxic therapy.

4 Aug 2010

Glycotope receives German, Italian regulatory approval for CetuGEX Phase I study for solid cancers

Glycotope GmbH, a leading glycobiology company, has received regulatory approval by German and Italian regulatory authorities for a Phase I study of Glycotope´s next generation antibody CetuGEX™ (GT-MAB 5.2-GEX) for the treatment of various solid cancers.

4 Aug 2010

$CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL$

CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL

Cell Therapeutics, Inc. today announced it has filed for a Special Protocol Assessment ("SPA") with the U.S. Food and Drug Administration ("FDA") for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").

4 Aug 2010

ZymoGenetics second-quarter net loss declines to $3.8 million

ZymoGenetics, Inc. today reported substantially improved financial results for the quarter ended June 30, 2010. For the second quarter of 2010, the company's net loss declined to $3.8 million, or $0.04 per share, a $23.2 million improvement from the $27.0 million loss, or $0.39 per share, reported for the second quarter of 2009. The improvement resulted from higher revenues as well as reduced operating expenses.

4 Aug 2010

Excaliard reports positive results from EXC 001 Phase 2 clinical trial for reducing scar severity

Excaliard Pharmaceuticals, Inc., today announced positive results from its Phase 2 clinical trial of EXC 001, a new chemical entity for reducing fibrosis. Results showed that EXC 001 treatment significantly reduced scar severity in subjects undergoing an elective abdominoplasty compared to placebo.

4 Aug 2010

Titan completes 60% enrollment in confirmatory Phase 3 clinical study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced that patient enrollment is more than 60% complete in the confirmatory Phase 3 clinical study of Probuphine for the treatment of opioid addiction, and the study is expected to complete enrollment by early fourth quarter of this year, which is almost three months ahead of schedule.

3 Aug 2010

Vical second-quarter revenues decrease to $2.1 million

Vical Incorporated today reported financial results for the three months and six months ended June 30, 2010. Revenues decreased to $2.1 million for the second quarter of 2010 from $4.0 million for the second quarter of 2009, primarily as a result of a $1.5 million milestone payment in 2009 from Merck & Co., Inc., based on Merck's ongoing Phase 1 clinical-stage development of an investigational cancer vaccine.

3 Aug 2010

First patient treated in Phase Ib expansion study of CUDC-101

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers.

3 Aug 2010

NWBT reports long-term follow-up data from DCVax-Brain immune therapy clinical trials for GBM

Northwest Biotherapeutics, Inc. today announced further positive long-term follow-up data from its prior Phase I and Phase I/II clinical trials, in which patients with newly diagnosed Glioblastoma multiforme ("GBM"), the most rapid and lethal type of brain cancer, were treated with NWBT's DCVax®-Brain personalized immune therapy.

3 Aug 2010

Researchers call for more public disclosure about clinical drug trials

When published results are systematically tracked for drug trials registered with ClinicalTrials.gov, those from industry-funded trials are the likeliest to be favorable to the drug in question, report researchers at Children's Hospital Boston. Publishing in the August 3 issue of the Annals of Internal Medicine, the researchers call for more public disclosure about clinical drug trials at their outset to reduce the possibility of bias in the findings.

3 Aug 2010

Antisense Pharma receives FDA IND authorisation for clinical studies with trabedersen for high-grade glioma

The biopharmaceutical company Antisense Pharma announced today that the US-American Food and Drug Administration (FDA) has issued an Investigational New Drug (IND)-authorisation for clinical studies with trabedersen for patients with high-grade glioma. This authorisation entitles the company to include US-American clinics both in the phase III study SAPPHIRE and in further studies.

3 Aug 2010

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

ArQule, Inc. and Daiichi Sankyo Co., Ltd. today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

3 Aug 2010

FDA approves N30 Pharma's NDA for N6022 GSNOR

N30 Pharmaceuticals, LLC today announced the approval of its Investigational New Drug Application for N6022 by the U.S. Food and Drug Administration. N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR), has the potential to be an important new treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD).

3 Aug 2010

Methods to boost neutralizing antibody may prevent HIV-1 transmission

Monkeys repeatedly immunized with a particular form the HIV-1 envelope glycoprotein generated antibodies capable of neutralizing diverse strains of HIV-1, according to a paper published online in the Journal of Experimental Medicine on August 2.

3 Aug 2010

Idera announces $15 million registered direct offering

Idera Pharmaceuticals today announced that it has received commitments from certain institutional investors to purchase approximately $15 million of securities in a registered direct offering. Idera expects to receive net proceeds of approximately $14.2 million after deducting placement agent fees and other offering expenses.

3 Aug 2010

Etoricoxib better than opioid drug tramadol for postoperative pain: Study

For patients with moderate pain after foot surgery, the cyclo-oxygenase 2 (COX-2) inhibitor drug etoricoxib provides better pain relief with fewer side effects than the opioid drug tramadol, concludes a study in the August issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

3 Aug 2010

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin Pharmaceutical Inc. announced today an update in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Data reported in this announcement reflect preliminary results as of July 23, 2010. Complete top-line results are expected in the fourth quarter of 2010.

3 Aug 2010

BioMarin reports $0.5 million GAAP net loss for second-quarter 2010

BioMarin Pharmaceutical Inc. today announced financial results for the second quarter of 2010. GAAP net loss was $0.5 million ($0.01 per diluted share) for the second quarter of 2010, compared to GAAP net income of $1.3 million ($0.01 per diluted share) for the second quarter of 2009. Non-GAAP net income was $8.6 million ($0.08 per diluted share) for the second quarter of 2010, compared to non-GAAP net income of $9.0 million ($0.09 per diluted share) for the second quarter of 2009.

3 Aug 2010

BioMarin completes BMN 195 Phase 1 clinical trial for Duchenne muscular dystrophy

BioMarin Pharmaceutical Inc. announced today that it has completed the Phase 1 clinical study of BMN 195, a small molecule utrophin up-regulator, for the treatment of Duchenne muscular dystrophy (DMD). The Phase 1 clinical trial was a single-center, double-blind, placebo-controlled, single-dose escalation study followed by a multiple-dose escalation study in healthy volunteers.

3 Aug 2010

Drug Trial News

Access Pharmaceuticals initiates Phase I/II dose escalating study for Thiarabine

Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

Glycotope receives German, Italian regulatory approval for CetuGEX Phase I study for solid cancers

CTI files SPA with FDA for new pixantrone phase III trial in relapsed or refractory aggressive B-Cell NHL

ZymoGenetics second-quarter net loss declines to $3.8 million

Excaliard reports positive results from EXC 001 Phase 2 clinical trial for reducing scar severity

Titan completes 60% enrollment in confirmatory Phase 3 clinical study of Probuphine for opioid addiction

Vical second-quarter revenues decrease to $2.1 million

First patient treated in Phase Ib expansion study of CUDC-101

NWBT reports long-term follow-up data from DCVax-Brain immune therapy clinical trials for GBM

Researchers call for more public disclosure about clinical drug trials

Antisense Pharma receives FDA IND authorisation for clinical studies with trabedersen for high-grade glioma

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

FDA approves N30 Pharma's NDA for N6022 GSNOR

Methods to boost neutralizing antibody may prevent HIV-1 transmission

Idera announces $15 million registered direct offering

Etoricoxib better than opioid drug tramadol for postoperative pain: Study

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin reports $0.5 million GAAP net loss for second-quarter 2010

BioMarin completes BMN 195 Phase 1 clinical trial for Duchenne muscular dystrophy

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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