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Micromet commences blinatumomab phase 2 trial for r/r B-precursor acute lymphoblastic leukemia

Micromet, Inc. today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body's T cells to kill cancer cells.

28 Nov 2011

Exelixis and NCI's CTEP enter CRADA to further evaluate cabozantinib

Exelixis, Inc. today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) for further evaluation of cabozantinib, Exelixis' lead compound, in a variety of solid tumors.

28 Nov 2011

Inspiration initiates second OBI-1 phase III clinical trial in congenital hemophilia A with inhibitors

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. has initiated the treatment of the first patient in the second of two pivotal studies from the OBI-1's Accur8 clinical trial program.

28 Nov 2011

Immunicum receives Swedish approval to commence first clinical trial of patented cancer vaccine

Immunicum, which is developing cancer vaccines, has received approval from the Swedish Medical Products Agency to start its first clinical trial. The study will be conducted on kidney cancer patients at the University Hospital in Uppsala. At the same time, the company secures substantial financing to complete the clinical trial.

25 Nov 2011

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that based on the recommendation from the Data Monitoring Committee (DMC) it will discontinue its pivotal double-blinded Phase III MAINSAIL trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer.

23 Nov 2011

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

Drug Trial News

Micromet commences blinatumomab phase 2 trial for r/r B-precursor acute lymphoblastic leukemia

Exelixis and NCI's CTEP enter CRADA to further evaluate cabozantinib

Inspiration initiates second OBI-1 phase III clinical trial in congenital hemophilia A with inhibitors

Immunicum receives Swedish approval to commence first clinical trial of patented cancer vaccine

Celgene to discontinue docetaxel and prednisone plus lenalidomide Phase III trial on CRPC

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

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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