Wednesday, April 6, 2011

Alnylam includes enrollment in ALN-VSP phase I trial


Alnylam pharmaceuticals, Inc. (NASDAQ: ALNY), a leading RNAi therapeutics company, announced today that it has completed I registration in the ALN-VSP phase multicentre, multinational, open-label, dose escalation clinical trial. The study goal was participation there, the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced solid tumors with liver to evaluate. ALN-VSP was access, treatment on the study still administered over 40 patients in doses of 0.1 to 1.5 mg / kg with several patients. Alnylam present program of the annual meeting of the American Society of Clinical Oncology (ASCO) meeting June 3-7, 2011 take place from his ALN-VSP data.

"We are pleased to complete registration in our phase I trial have with ALN-VSP," said Jared m. Gollob, m.d., Senior Director, clinical research at the Alnylam. "The data from this programme have been encouraging, and the results are important not only for the further advancement of ALN-VSP towards phase II studies, but also for the entire development of the systemically delivered RNAi therapeutics." We present you with updated data from the phase I study at the ASCO Annual meeting in June. "

"Primary liver cancer and liver metastases poor prognosis for the patient are associated with both new therapies are clearly necessary," said hospital in Barcelona Spain Josep Tabernero, m.d., Chairman of the Department of medical oncology and phase I program in Vall d ' Hebron University. "This study is an important step in the development of a novel therapeutic strategy of to this devastating disease deal with, and we are looking forward to all the data from this study review."

Program clinical of ALN-VSP

ALN-VSP is Alnylam's first systemic RNAi program and provides the company the first clinical program in oncology. ALN-VSP is a systemically delivered RNAi therapeutic consisting of two SiRNAs developed, to two genes crucial to the growth and survival of cancer cells target: vascular endothelial growth factor (VEGF) and kinesin spindle protein (KSP), also known as Eglin 5 (Eg5). The drug is formulated developed into one of the first generation of lipid nanoparticles of Tekmira Pharmaceuticals Corporation. The ALN-VSP phase I trial is a multicentre, multinational, open label, dose escalation study developed, register to patients with advanced solid tumors involving the liver, to answer or to standard advanced have failed treatment have. The primary goal is it, safety and tolerability of up to eight possible doses of 0.1 up to 1.7 mg / kg. Secondary objectives are the characterization of the pharmacokinetics and evaluation of pharmacodynamic effects and tumor response by response evaluation criteria for solid tumors (RECIST), a series of published guidelines that define when cancer patients improved disease stabilizes or progresses during treatment; Change of tumor blood flow or vascular permeability measured on dynamic contrast - enhanced magnetic resonance imaging (DCE-MRI); in the plasma biomarkers of angiogenesis change; and molecular and cellular analysis of tumor biopsy samples. Alnylam present program of the annual meeting of the American Society of Clinical Oncology (ASCO) meeting June 3-7, 2011 take place from his ALN-VSP data. The company expects its ALN-VSP program before initiating a clinical phase II study with the aim of the introduction of this study in the year 2012 partner.

Cancer liver

One of the poorest survival rates in Oncology is cancer, effects on the liver known as primary or secondary liver cancer, and provides an important unmet medical need affect a large number of patients around the world. Primary liver cancer and hepatocellular carcinoma (HCC), is one which most worldwide, each year diagnosed cancers with more than 600,000 people. Secondary liver cancer, also known as metastatic liver cancer, cancer is common, from a different part of the body caused by other common cancers such as colon, lung and breast cancer to the liver. Worldwide, more than 500,000 people with secondary liver cancer are diagnosed each year.

About RNA interference (RNAi)

RNAi (RNA interference) is a revolution in biology, representing a breakthrough understanding how genes are in cells and a completely new approach to drug discovery and development of high-frequency field. The discovery has announced, as "a scientific breakthrough is done once every ten years or so," and one of the most promising and rapidly advancing frontiers in biology and drug discovery today is that 2006 was awarded the Nobel Prize for Physiology or medicine. RNAi is a natural process of gene silencing to bring that occurs in organisms of plants up to mammals. Through the use of the natural biological process of RNAi, in our cells, is the creation of a major new class of drugs known as RNAi therapeutics, on the horizon. Annoying Small RNAs (SiRNAs), which prevents molecules that mediate RNAi and include Alnylam's RNAi therapeutic platform that targets the cause of diseases by you certain mRNAs, and proteins. RNAi therapeutics have the potential to treat diseases and patients new ground to help.

Source:
Alnylam pharmaceuticals
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