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Treatment of Type 1 diabetes patients with DiaPep277- may have several medical benefits

The clinical trial was random, regulated, double-blinded and broad-based. The drug was tested on 457 patients, aged 16-45, who had been diagnosed with Type 1 diabetes a short time before joining the trial. The trial took place in around 40 medical centers in Europe, Israel and South Africa. The patients in the trial were randomly assigned to one of two groups: One received the trial drug (DiaPep277-) through a subcutaneous injection once every three months, for a period of two years, while the control group was given a placebo in the same way.

23 Nov 2011

Arginine may reactivate T-cells in patients with glioblastoma

In many cases, tumors suppress a patient's immune system in a way that keeps the cancer safe from immune system attack. This is particularly true for patients with glioblastoma, a primary brain tumor that carries a prognosis of only 12-15 months survival after diagnosis.

22 Nov 2011

Study: Vaccine development efforts currently focus on incidence rather than mortality rates

Drug companies currently developing therapeutic cancer vaccines may be determining the cancers they target based on the number of annual cases, not the number of deaths they cause.

22 Nov 2011

Nature Medicine publishes dexpramipexole Phase 2 ALS study results

Knopp Biosciences LLC today announced the publication in Nature Medicine of comprehensive results from the Phase 2 study of dexpramipexole, a small-molecule modulator of mitochondrial bioenergetics, in people with amyotrophic lateral sclerosis.

21 Nov 2011

Akebia commences dosing in AKB-9778 Phase 1 study for diabetic macular edema and retinopathy

Akebia Therapeutics, Inc., a small molecule discovery and development company focused on anemia and vascular disorders, today announced that it has dosed the first subjects in a first-in-man Phase 1 study of AKB-9778, a first-in-class human protein tyrosine phosphatase beta (HPTPβ) inhibitor in development for diabetic macular edema (DME) and diabetic retinopathy (DR).

21 Nov 2011

SAFC commences process validation activities for Oncolytics' REOLYSIN

Oncolytics Biotech Inc. today announced that SAFC, a Division of Sigma-Aldrich Corporation, has commenced validation activities designed to demonstrate the manufacturing process for the commercial production of REOLYSIN, Oncolytics' proprietary formulation of reovirus, is robust and reproducible.

21 Nov 2011

PLoS ONE publishes study on darinaparsin, a multivalent chemotherapeutic

ZIOPHARM Oncology, Inc. announced today the publication of a darinaparsin (Zinapar or ZIO-101) study in the PLoS ONE, an international, peer-reviewed, open-access, online publication of the Public Library of Science.

21 Nov 2011

Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Celldex Therapeutics, Inc. today announced the presentation of mature overall survival (OS) data for ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB).

21 Nov 2011

Multi-center cabozantinib trial for hormone receptor-positive breast cancer with bone metastases initiated

Exelixis, Inc. today announced the initiation of an investigator-sponsored trial of cabozantinib in women with hormone receptor-positive breast cancer with bone metastases.

21 Nov 2011

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today positive preliminary results from its Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

21 Nov 2011

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention.

21 Nov 2011

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been selected by Tasly Pharmaceuticals for the company's global Phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States.

21 Nov 2011

EMA validates Pfizer's Market Authorisation Application for tofacitinib to treat rheumatoid arthritis

Pfizer Inc. announced today that its Market Authorisation Application for tofacitinib (development code CP-690,550), a novel, oral JAK inhibitor being studied for the treatment of moderate-to-severe active rheumatoid arthritis (RA), has been validated by the European Medicines Agency (EMA).

21 Nov 2011

Convergence commences CNV2197944 multiple ascending dose Phase I study for chronic pain

Convergence Pharmaceuticals Limited, the company focused on the development of novel and high value analgesic medicines, today announces that the multiple ascending dose Phase I study of the novel, first in class calcium channel blocker CNV2197944, for the treatment of chronic pain has been initiated.

21 Nov 2011

Promising results from dexpramipexole phase 2 trial on ALS

Treatment with dexpramipexole - a novel drug believed to prevent dysfunction of mitochondria, the subcellular structures that provide most of a cell's energy - appears to slow symptom progression in the neurodegenerative disease amyotrophic lateral sclerosis (ALS). Promising results of a phase 2 trial of dexpramipexole are receiving advance online publication in Nature Medicine.

20 Nov 2011

PEPFAR Scientific Advisory Board report offers six recommended research priorities

This post in the Center for Global Health Policy's "Science Speaks" blog examines a report by the PEPFAR Scientific Advisory Board (SAB) that offers six recommended treatment and prevention research priorities to U.S. Global AIDS Ambassador Eric Goosby and the Office of the Global AIDS Coordinator (OGAC) to guide future PEPFAR programs.

19 Nov 2011

Combo hormone therapy increases risk of breast cancer in women with new-onset tenderness

The debate about using menopausal hormone therapies to relieve symptoms in post-menopausal women has been ongoing. Is the combination therapy of estrogen and progestin better or worse than just giving women estrogen alone? In women who still have a uterus (those who have not had a hysterectomy), progestin counteracts the increased risk of uterus cancer when estrogen is given alone, but at the expense of an increase in breast cancer risk compared to estrogen alone.

19 Nov 2011

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

Merrimack Pharmaceuticals, Inc. announced today that the first patient has been dosed in a Phase 2 clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with erlotinib, a small molecule directed at the epidermal growth factor receptor (EGFR), in three groups of patients with metastatic non-small cell lung cancer.

18 Nov 2011

FDA Commissioner revokes approval of Genentech's Avastin for treatment of mBC

Genentech, a member of the Roche Group, announced today that the FDA Commissioner is revoking the approval of Avastin (bevacizumab) for the treatment of mBC in the United States.

18 Nov 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Drug Trial News

Treatment of Type 1 diabetes patients with DiaPep277- may have several medical benefits

Arginine may reactivate T-cells in patients with glioblastoma

Study: Vaccine development efforts currently focus on incidence rather than mortality rates

Nature Medicine publishes dexpramipexole Phase 2 ALS study results

Akebia commences dosing in AKB-9778 Phase 1 study for diabetic macular edema and retinopathy

SAFC commences process validation activities for Oncolytics' REOLYSIN

PLoS ONE publishes study on darinaparsin, a multivalent chemotherapeutic

Consistent data from three studies support plans for rindopepimut with ACT IV Phase 3 study

Multi-center cabozantinib trial for hormone receptor-positive breast cancer with bone metastases initiated

Positive preliminary results from Alnylam's ALN-TTR01 Phase I clinical trial for TTR-mediated amyloidosis

Selecta commences SEL-068 Phase 1 clinical trial for smoking cessation and relapse prevention

ICON selected as CRO for Tasly's Dantonic pill global Phase III studies for chronic stable angina pectoris

EMA validates Pfizer's Market Authorisation Application for tofacitinib to treat rheumatoid arthritis

Convergence commences CNV2197944 multiple ascending dose Phase I study for chronic pain

Promising results from dexpramipexole phase 2 trial on ALS

PEPFAR Scientific Advisory Board report offers six recommended research priorities

Combo hormone therapy increases risk of breast cancer in women with new-onset tenderness

Merrimack initiates MM-121 Phase 2 combination trial in metastatic NSCLC

FDA Commissioner revokes approval of Genentech's Avastin for treatment of mBC

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

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How industrial hygiene flow calibration supports defensible exposure data

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