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Ablynx NV, of Ghent, Belgium, will make an oral and poster presentation for arthritis candidate, ALX-0061, at the Annual European Congress of Rheumatology in Madrid, Spain, showing a strong efficacy and safety profile for the drug in a Phase II study. Pooled data at 24 weeks of treatment demonstrated that ALX-0061 led to an improvement of 84 percent in ACR20 and 58 percent DAS28 remission. At all doses, the drug was well tolerated with no clinically relevant neutropenia, no clinicallyBioWorld International | Wednesday, June 19, 2013 -
Pharma: Clinic Roundup
Data from secondary biomarker endpoints of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels were further supportive of the findingsBioWorld Today | Tuesday, June 18, 2013 -
Phase I Clinical Trials Update: May 2013
growth factor Interstitial cystitis/bladder pain syndrome Completed dosing in its Phase I study 5/17/13 Trevi Therapeutics Inc. (New Haven, Conn.) Nalbuphine hydrochloride Extended-release tablets End-stage renal disease Started a Phase I trial 5/7/13 Umecrine Mood AB (Solna, Sweden) UC1010 Inhibits the provocateur to act on the emotional center of the brain Premenstrual dysphoric disorder Began dosing in a Phase I/II trial 5/24/13 Versartis Inc. (Redwood City, Calif.) VRS-317 A long-acting formBioWorld Insight | Monday, June 17, 2013 -
FDA Submissions, Approvals & Other Actions: May 2013
growth factor receptor-activating mutations 5/16/13 Jennerex Biotherapeutics Inc. (San Francisco) Pexa-Vec JX-594BioWorld Insight | Monday, June 17, 2013 -
Phase II Clinical Trials Update: May 2013
growth factor 19 and improvement in clinical symptoms 5/21/13 INFECTION Chimerix Inc. (Durham, N.C.) CMX001 Oral nucleotide analog lipid-conjugate Cytomega-lovirus Data demonstrated its high barrier to viral resistance in the prevention and treatment of the infection 5/17/13 Gilead Sciences Inc. (Foster city, calif.) Sofosbuvir and ledipasvir Once-daily fixed-dose combination tablet Hepatitis C virus Interim Phase II data showed a sustained virologic response four weeks after completing therapyBioWorld Insight | Monday, June 17, 2013 -
Clinic Roundup
RXI-109 is a self-delivering RNAi that is designed to reduce expression of a protein known as connective tissue growth factor (CTGFBioWorld Today | Thursday, June 13, 2013 -
Pfizer Keeping the ADC Faith: Potential $635M CytomX Deal
Both previous tie-ups involve Ambrx's protein medicinal chemistry technology, one targeting fibroblast growth factor 21 for Type II diabetes and the other focused on the relaxin hormone for the treatment of heart failureBio Perspectives | Wednesday, June 12, 2013 -
Aveo Receives CRL from FDA After Stopping RCC Program
That decision was made in the wake of the FDA's Oncology Drugs Advisory Committee (ODAC) 13-1 vote against the adequacy of Aveo Pharmaceuticals Inc.'s tivozanib, an inhibitor of all three vascular endothelial growth factor receptors, in renal cell carcinoma (RCCBy Peter Winter | BioWorld Today | Tuesday, June 11, 2013 -
AVEO Terminates RCC Program, Cuts Workforce to Conserve Cash
In the wake of the FDA's Oncology Drugs Advisory Committee (ODAC) 13-1 vote against the adequacy of AVEO Pharmaceuticals Inc.'s tivozanib, an inhibitor of all three vascular endothelial growth factor (VEGF) receptors, in renal cell carcinoma (RCC) there were several losers: patients, the company and its staffBy Peter Winter | BioWorld Insight | Monday, June 10, 2013 -
Bench Press: BioWorld Looks at Translational Medicine
The authors used gene therapy to deliver two genes for growth factors directly into the brains of transgenic mice that are transgenic for one part of mutant huntingtin and so develop the equivalent of Huntington's diseaseBioWorld Today | Monday, June 10, 2013 -
Clinic Roundup
RXi Pharmaceuticals Corp., of Westborough, Mass., disclosed the unblinded results of the first of two placebo-controlled double-blind studies in volunteers with anti-scarring agent RXI-109, an sd-rxRNA compound that has been shown in vitro and in animals to reduce mRNA for connective tissue growth factorBioWorld Today | Friday, June 7, 2013 -
Pfizer Keeping the ADC Faith: Potential $635M CytomX Deal
Both previous tie-ups involve Ambrx's protein medicinal chemistry technology, one targeting fibroblast growth factor 21 for Type II diabetes and the other focused on the relaxin hormone for the treatment of heart failureBy Randy Osborne | BioWorld Today | Friday, June 7, 2013 -
BioMarin Launches Phase III Program for Phenylketonuria
Its product candidates include Vimizim (N-acetylgalactosamine 6-sulfatase), BMN-701 , a fusion protein of insulin-like growth factor 2 and acid alpha glucosidase, for Pompe disease, BMN-673 for genetically defined cancers and BMN-111 for achondroplasiaBy Catherine Shaffer | BioWorld Today | Thursday, June 6, 2013 -
Morphosys, GSK Ink $586M Pact for MOR103 in RA, MS
GM-CSF was first recognized as a growth factor for white blood cells back in the late 1980s, and recombinant GM-CSF has long been used to treat neutropenia in cancer patientsBio Perspectives | Wednesday, June 5, 2013 -
Morphosys, GSK Ink $586M Pact for MOR103 in RA, MS
GM-CSF was first recognized as a growth factor for white blood cells back in the late 1980s, and recombinant GM-CSF has long been used to treat neutropenia in cancer patientsBy Cormac Sheridan | BioWorld International | Wednesday, June 5, 2013 -
Bergenbio's AXL-Kinase Inhibition Potential Is Broad
AXL kinase is central to the cell-to-cell signal transduction process known as epithelial-mesenchymal transition (EMT), by which cancer cells escape to form metastases and also is involved in the development of resistance to chemotherapeutics, most notably epidermal growth factor receptor (EGFR)-targeted therapiesBy Nuala Moran | BioWorld International | Wednesday, June 5, 2013 -
Morphosys, GSK Ink $586M Pact for MOR103 in RA, MS
GM-CSF was first recognized as a growth factor for white blood cells back in the late 1980s, and recombinant GM-CSF has long been used to treat neutropenia in cancer patientsBy Cormac Sheridan | BioWorld Today | Wednesday, June 5, 2013 -
Bergenbio's AXL-Kinase Inhibition Potential is Broad
AXL kinase is central to the cell-to-cell signal transduction process known as epithelial-mesenchymal transition (EMT), by which cancer cells escape to form metastases and also is involved in the development of resistance to chemotherapeutics, most notably epidermal growth factor receptor (EGFR) targeted therapiesBy Nuala Moran | BioWorld Today | Tuesday, June 4, 2013 -
ASCO Roundup
AbbVie Inc., of Chicago, reported results from a Phase I study of ABT-199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and relapsed/refractory non-Hodgkin's lymphoma (NHL). The Phase I, open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the pharmacokinetics of ABT-199 inBioWorld Today | Tuesday, June 4, 2013 -
Clovis Lung Data Wow; PARP Inhibitor Makes Impression, too
CO-1686, a targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M, garnered four confirmed partial responses (PRs) in heavily pre-treated patients, and "may not yet even be close to the maximum tolerated dose (MTD)," wrote J.P. Morgan analyst Cory Kasimov in a research reportBy Randy Osborne | BioWorld Today | Tuesday, June 4, 2013
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