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debrajo's picture
Posts: 1095
Joined: Sep 2011

Has anyone been hearing about the "exciting" new drug going into trials at M.D>Anderson? Every one here is buzzing about something called AV-203. Seems like it is for solid tumors, but I'm not smart enough to make heads or tails about. Maybe some of you smarter ones can check it out. Best, debrajo

txtrisha55's picture
Posts: 696
Joined: Apr 2011

AVEO Launches AV-203 Trial
Thu, 05/31/2012 - 8:32am
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AVEO Oncology announced the initiation of a Phase 1 study examining the safety and preliminary efficacy of AV-203 along with exploratory biomarkers in patients with advanced solid tumors. AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3, a new and promising strategy for treating cancer. AV-203 was developed through AVEO’s Human Response Platform, which evaluates drugs that can block the function of cancer-causing target genes and identifies biomarkers that are indicators of drug response or resistance in patients. This advancement marks the third AVEO product candidate to enter clinical development.

“We believe ERBB3 represents an exciting new oncology target,” said George Blumenschein, Jr., M.D., associate professor of medicine thoracic/head and neck medical oncology at the University of Texas, M.D. Anderson Cancer Center, and lead investigator of the AV-203 Phase 1 study. “Research has indicated ERBB3 acts as a central node of oncogenic signaling. It may play a critical role not only in tumor formation and proliferation across a broad range of cancer types, but also in the development of resistance to currently used EGFR and HER2 inhibitors. AV-203 has demonstrated potent inhibition of activated ERBB3 in a variety of human tumor models with different genetic backgrounds. I look forward to evaluating the utility of AV-203 as a potential new therapeutic option for patients living with cancer.”

The AV-203 Phase 1 trial, a multi-center, dose-escalation study, will evaluate the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AV-203 in subjects with metastatic or advanced solid tumors. Secondary endpoints in the study include characterizing the pharmacokinetic (PK) profile of AV-203 and anti-drug antibody levels, and evaluating the preliminary anti-tumor activity. A core component of the study will be the exploration of predictive biomarkers for AV-203 response identified using AVEO’s Human Response Platform. Up to 30 patients are expected to enroll in the dose-escalation portion of the study, and up to 60 additional patients may be enrolled in the biomarker exploration component of the study.

“With the initiation of this trial, we now have three targeted oncology therapeutic candidates in clinical development, all of which use distinct and novel mechanisms of action to fight cancer,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “The successful advancement of AV-203 into the clinic and the identification of a potential biomarker of AV-203 response provide further validation of the advantages of our proprietary Human Response Platform.”

Date: May 23, 2012

HellieC's picture
Posts: 524
Joined: Nov 2010

This is a Phase I study (only just gone beyond the "first into man" stage by the looks of it). It appears that this compound has shown anti tumour activity in pre clinical work (lab animals usually) in a number of tumour types including breast and ovarian and so now moves on to human trials.
Basically, they will recruit a limited number of patients in this very early phase study, to determine safety, tolerability and to work out the maximum tolerated dose, before moving onto a large number of patients to look at efficacy more closely.
It all looks promising, but we need to remember that the attrition rate for drugs in early development is quite high, so it may not go the distance. But for anyone who is out of other options, this trial appears to be still recruiting.
Lets hope that this compound, and others in the development pipelines, come on stream soon - we need all the help we can get!
Kindest wishes

debrajo's picture
Posts: 1095
Joined: Sep 2011

Thanks Helen and Trish. I hope it was for all cancer instead of specific kinds like so many. I didn't have a solid tumor, but it seemed geer for the heavy, last resort type of cancer. Everyone at MD Anderson is on the band-wagon already,but it looks like it will still be years.(sigh) best, debrajo

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