AVRX » Topics » AVN944 Program

These excerpts taken from the AVRX 10-K filed Mar 31, 2008.
AVN944 Program
 
AVN944 is an oral, small molecule drug being developed for the treatment of hematologic and solid cancers. We filed an Investigational New Drug application (“IND”) in September 2005 with the Food and Drug Administration (“FDA”) and initiated U.S. Phase I clinical trials of AVN944 in cancer patients in January 2006 for the treatment of hematologic cancers (leukemia, myeloma and lymphoma). This Phase I trial is evaluating the maximum tolerated dose (MTD), the safety, the pharmacokinetic and pharmacodynamic profile and efficacy of AVN944. It is focused on patients with hematologic cancers that have failed prior therapies, or for whom there is no recommended treatment, and includes analysis of a number of biomarkers that correlate with IMPDH inhibition.
 
In 2006, and again in 2007, interim analysis of the Phase I trial showed encouraging results in patients. Importantly, a significant number of patients experienced stable disease after one cycle of therapy with AVN944. Two patients with multiple myeloma were on study with stable disease for 12 months. We believe that these data, combined with a thorough analysis of pharmacodynamic markers using AvalonRx®, demonstrate clear mechanism-based biologic activity of the drug in patients. In November 2007, we discontinued enrollment of patients with chronic lymphocytic leukemia because of difficulty interpreting the safety profile in these patients. We are continuing to enroll patients with multiple myeloma, lymphoma and acute leukemia in this study. We initiated Phase II clinical testing of AVN944 during 2007 with a study of AVN944 plus gemcitabine in patients with previously untreated, advanced stage pancreatic cancer. The first portion of the study is designed to find the optimal dose of AVN944 in combination with a standard dose of gemcitabine.
 
AVN944
Program



 



AVN944 is an oral, small molecule drug being developed for the
treatment of hematologic and solid cancers. We filed an
Investigational New Drug application (“IND”) in
September 2005 with the Food and Drug Administration
(“FDA”) and initiated U.S. Phase I clinical
trials of AVN944 in cancer patients in January 2006 for the
treatment of hematologic cancers (leukemia, myeloma and
lymphoma). This Phase I trial is evaluating the maximum
tolerated dose (MTD), the safety, the pharmacokinetic and
pharmacodynamic profile and efficacy of AVN944. It is focused on
patients with hematologic cancers that have failed prior
therapies, or for whom there is no recommended treatment, and
includes analysis of a number of biomarkers that correlate with
IMPDH inhibition.


 



In 2006, and again in 2007, interim analysis of the Phase I
trial showed encouraging results in patients. Importantly, a
significant number of patients experienced stable disease after
one cycle of therapy with AVN944. Two patients with multiple
myeloma were on study with stable disease for 12 months. We
believe that these data, combined with a thorough analysis of
pharmacodynamic markers using
AvalonRx®,
demonstrate clear mechanism-based biologic activity of the drug
in patients. In November 2007, we discontinued enrollment of
patients with chronic lymphocytic leukemia because of difficulty
interpreting the safety profile in these patients. We are
continuing to enroll patients with multiple myeloma, lymphoma
and acute leukemia in this study. We initiated Phase II
clinical testing of AVN944 during 2007 with a study of AVN944
plus gemcitabine in patients with previously untreated, advanced
stage pancreatic cancer. The first portion of the study is
designed to find the optimal dose of AVN944 in combination with
a standard dose of gemcitabine.


 




This excerpt taken from the AVRX 10-K filed Mar 30, 2007.
AVN944 Program
 
AVN944 is an oral, small molecule drug being developed for the treatment of hematologic and solid cancers. In February 2005, we licensed AVN944 from Vertex Pharmaceuticals Incorporated. We subsequently filed an Investigational New Drug application (“IND”) in September 2005 with the Food and Drug Administration (“FDA”) and initiated U.S. Phase I clinical trials of AVN944 in cancer patients in January 2006 for the treatment of hematologic cancers (leukemia and lymphoma). Leukemia and lymphoma afflict approximately 700,000 people and lead to over 54,000 deaths, or nearly 10% of all cancer deaths, in the United States each year. This Phase I trial is evaluating the maximum tolerated dose (MTD), the safety, the pharmacokinetic and pharmacodynamic profile and efficacy of AVN944. It is focused on patients with hematologic cancers that have failed prior therapies, or for whom there is no recommended treatment, and includes analysis of a number of biomarkers that correlate with IMPDH inhibition.
 
In 2006, an interim analysis of the Phase I trial showed encouraging results in patients. Importantly, a significant number of patients experienced stable disease after one cycle of therapy with AVN944. Two patients with multiple myeloma were on study with stable disease for 12 months. Additionally, several leukemia patients have received three or more cycles of the drug. We believe that these data, combined with a thorough analysis of pharmacodynamic markers using AvalonRx®, demonstrate clear mechanism-based biologic activity of the drug in patients. We intend to initiate Phase II clinical testing of AVN944 during 2007.
 
This excerpt taken from the AVRX 10-K filed Mar 31, 2006.
AVN944 Program
 
AVN944 is an oral delivery, small molecule drug candidate discovered by Vertex that we licensed from Vertex in February 2005. Before we licensed AVN944 from Vertex, Vertex conducted preclinical studies on AVN944 beginning in September 1999 and concluded active experimentation on AVN944 in December 2004. Results from these preclinical studies of AVN944 indicate that AVN944 can inhibit the proliferation of leukemia cells and prolong survival of mice with leukemia. In a Phase I clinical trial of AVN944 conducted in the United Kingdom in healthy volunteers, AVN944 demonstrated a favorable safety profile and a significant inhibitory effect on IMPDH enzyme activity. We believe that these results, in combination with results from preclinical testing, indicate that AVN944 has the potential to have clinical benefit for patients with cancer.
 
We filed an IND with the Food and Drug Administration (“FDA”) in 2005 and initiated U.S. Phase I clinical trials of AVN944 in cancer patients in January 2006 for the treatment of hematological cancers such as leukemia and lymphoma, which afflict approximately 700,000 people in the United States and lead to over 54,000 deaths, or nearly 10% of all cancer deaths, in the United States each year. This Phase I trial is evaluating the maximum tolerated dose of AVN944. It is focusing on patients with hematological cancers that have failed prior therapies, or for whom there is no recommended treatment, and includes pharmacokinetic analysis of the drug candidate and analysis of a number of biomarkers that correlate with IMPDH inhibition. We intend to use AvalonRx® to analyze the gene expression responses that are characteristic of IMPDH inhibition from both in vitro and in vivo experiments in solid tumor models and hematological cancers, and translate those responses for clinical trial use.
 
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