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Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced top-line results from a successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558 program is now poised to enter Phase 3 studies.

20 Jul 2010

Archer Biosciences initiates third drug-escalation cohort in TPI-287 trial for metastatic melanoma

Archer Biosciences, Inc. announced that the trial of its novel, proprietary drug TPI-287 (an abeotaxane) for the treatment of metastatic melanoma has initiated a third drug-escalation cohort. The primary objective of this study is to determine the safety, tolerability and maximum tolerated dose (MTD) of TPI-287 in combination with temozolomide (TMZ) in adult patients with metastatic melanoma.

20 Jul 2010

KAI Pharmaceuticals completes enrollment in Phase 1 study of KAI-4169 for SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced the Company has completed enrollment in a Phase 1 study of KAI-4169, a novel pharmaceutical agent for the treatment of secondary hyperparathyroidism, which is a frequent complication of end stage renal disease.

20 Jul 2010

Seattle Genetics, Agensys commence ASG-5ME ADC phase I clinical trial for metastatic pancreatic cancer

Seattle Genetics, Inc. and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.

20 Jul 2010

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

Researchers who conducted a study testing a vaginal microbicide with an antiretroviral (ARV) drug called tenofovir found its use before and after sex was significantly more protective against HIV infection than a placebo gel among women at high risk of HIV. Results of the study, known as CAPRISA 004, are to be reported at the International AIDS Conference (AIDS 2010) in Vienna and published online by the journal Science.

20 Jul 2010

Global Campaign for Microbicides praises CAPRISA 004 gel trial for women's HIV prevention

Results of an advanced clinical trial of an antiretroviral-based microbicide candidate are being announced at the International AIDS Conference in Vienna, Austria. The CAPRISA 004 trial, which tested the safety and effectiveness of 1% tenofovir gel among nearly 900 women at two sites in South Africa, found that using the gel before and after sex provided moderate protection against sexually transmitted HIV.

20 Jul 2010

Aegera reports data from Phase 1 portion of combination AEG35156 Phase 1-2 study for primary liver cancer

Aegera Therapeutics Inc. released today encouraging survival data from the Phase 1 portion of its Phase 1-2 Study of the novel targeted therapeutic, AEG35156, given in combination with sorafenib in patients with advanced hepatocellular carcinoma (primary liver cancer).

20 Jul 2010

AVAC applauds CAPRISA 004 microbicide gel trial for preventing sexual transmission of HIV infection

"This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection," said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.

20 Jul 2010

Argos' Arcelis immunotherapy reduces viral load in interim analysis of Phase 2 HIV trial

Argos Therapeutics today announced that, in an interim analysis of a Phase 2 trial, its Arcelis immunotherapy targeted at HIV, AGS-004, demonstrated a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment interruption (ARTI) when compared to pre-ART viral loads.

20 Jul 2010

Researchers make scientific breakthrough in fight against HIV, genital herpes with a vaginal gel

Researchers have achieved an important scientific breakthrough in the fight against HIV and genital herpes with a vaginal gel that significantly reduces a woman's risk of being infected with these viruses. The results of the ground-breaking safety and effectiveness study of an antiretroviral microbicide gel study were reported today by the Centre for the AIDS Programme of Research in South Africa at the XVIII International AIDS Conference in Vienna, Austria.

20 Jul 2010

USAID Administrator issues statement on CAPRISA 004 trial for preventing HIV infection in women

USAID is proud to be the major funder of the first-ever proof of concept that a microbicide can effectively and safely reduce the transmission of HIV from men to vulnerable women. An achievement of this magnitude could not have been possible without collaboration among governments, scientists, communities, and individual women at risk of HIV.

20 Jul 2010

MDMA (Ecstasy) holds promise for chronic treatment-resistant PTSD

MDMA (-3,4-methylenedioxymethamphetamine, also known as Ecstasy), may one day offer hope for individuals with posttraumatic stress disorder (PTSD), even people for whom other treatments have failed. Clinical trial results out today in the Journal of Psychopharmacology, published by SAGE, suggests that MDMA can be administered to subjects with PTSD without evidence of harm and could offer sufferers a vital window with reduced fear responses where psychotherapy can take effect.

20 Jul 2010

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

A Phase 3 open-label study, recently published online by Pain Practice, has compared tapentadol extended release tablets, an investigational pain medication, to an existing prescription pain medication, oxycodone controlled release tablets.

20 Jul 2010

CytRx updates on progress in clinical development of bafetinib in three oncology indications

CytRx Corporation, a biopharmaceutical company specializing in oncology, announces progress with its clinical program to evaluate the preliminary efficacy and safety of its drug candidate bafetinib in three oncology indications. The Company has enrolled its first patient in a Phase 2 proof-of-concept trial in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL), is reporting rapid advancement toward the initiation of a Phase 2 proof-of-concept trial in advanced prostate cancer, and is on track to begin clinical evaluation later this year in glioblastoma multiforme, a common and aggressive type of primary brain tumor.

20 Jul 2010

Pfizer suspends chronic low back pain, diabetic peripheral neuropathy studies in tanezumab clinical program

Pfizer Inc. today announced, at the request of the U.S. Food and Drug Administration (FDA), the suspension of the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain.

20 Jul 2010

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. today announced the initiation of the pivotal Phase III clinical trial for palifosfamide in patients with front-line metastatic soft tissue sarcoma. The study, called PICASSO 3, is an international, randomized, double-blinded, placebo-controlled trial designed to enroll approximately 424 patients with metastatic soft tissue sarcoma who have never been treated with chemotherapy for metastatic disease.

20 Jul 2010

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.

20 Jul 2010

Benefits of drug L-methionine for neurogenic bladder disorders unclear

It is unclear whether patients with neurogenic bladder disorders benefit from the drug L-methionine. The only study currently available provides neither proof of benefit nor proof of harm. This is the result of a report published by the German Institute for Quality and Efficiency in Health Care (IQWiG) on 12 July 2010.

20 Jul 2010

Amira achieves two clinical development milestones in FLAP program for asthma

"Amira Pharmaceuticals, Inc. announced today that its FLAP (5-lipoxygenase-activating protein) program, which is partnered with GlaxoSmithKline, has achieved two clinical development milestones."

19 Jul 2010

Oncolytics Biotech receives Canadian approval for combination REOLYSIN Phase 3 trial in head, neck cancer

Oncolytics Biotech Inc. today announced that it has received a No Objection Letter from Health Canada to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.

19 Jul 2010

Drug Trial News

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Archer Biosciences initiates third drug-escalation cohort in TPI-287 trial for metastatic melanoma

KAI Pharmaceuticals completes enrollment in Phase 1 study of KAI-4169 for SHPT

Seattle Genetics, Agensys commence ASG-5ME ADC phase I clinical trial for metastatic pancreatic cancer

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

Global Campaign for Microbicides praises CAPRISA 004 gel trial for women's HIV prevention

Aegera reports data from Phase 1 portion of combination AEG35156 Phase 1-2 study for primary liver cancer

AVAC applauds CAPRISA 004 microbicide gel trial for preventing sexual transmission of HIV infection

Argos' Arcelis immunotherapy reduces viral load in interim analysis of Phase 2 HIV trial

Researchers make scientific breakthrough in fight against HIV, genital herpes with a vaginal gel

USAID Administrator issues statement on CAPRISA 004 trial for preventing HIV infection in women

MDMA (Ecstasy) holds promise for chronic treatment-resistant PTSD

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

CytRx updates on progress in clinical development of bafetinib in three oncology indications

Pfizer suspends chronic low back pain, diabetic peripheral neuropathy studies in tanezumab clinical program

ZIOPHARM Oncology commences palifosfamide Phase III clinical trial for metastatic soft tissue sarcoma

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Benefits of drug L-methionine for neurogenic bladder disorders unclear

Amira achieves two clinical development milestones in FLAP program for asthma

Oncolytics Biotech receives Canadian approval for combination REOLYSIN Phase 3 trial in head, neck cancer

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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