Replies to post #35013 on Biotech Values

[rfj1862]

>Why not go whole hog and prepare a ReadMeFirst primer for ITMN? They are a company I would like to know more about.<

Me too. I owned ITMN a few years ago, but haven't kept up.

Besides, I need ideas for where to put my DVAX money :-)

J

[mskatiescarletohara]

ITMN submits CTA in Europe, twice daily dosing implied perhaps for their HCV PI, enrollment should commence by EOY.


InterMune Submits Clinical Trial Authorization Application for ITMN-191 for Hepatitis C Infections
Tuesday September 26, 1:57 pm ET


BRISBANE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today that it has submitted an electronic Clinical Trial Authorization (CTA) application to the French Medicinal and Biological Products Evaluation Directorate (AFSSAPS) for ITMN-191, an orally available hepatitis C virus (HCV) protease inhibitor, developed in a collaboration between InterMune research scientists and Array BioPharma, Inc. Upon successful review by the Directorate and local Ethics Committee, InterMune will initiate the Phase I clinical program of ITMN-191.

InterMune has successfully completed preclinical toxicology and pharmacokinetic studies in multiple species in support of initiating Phase I clinical studies of ITMN-191. The CTA includes results of 28-day preclinical toxicology studies utilizing doses many-fold higher than those expected to be given to humans. These studies demonstrate a favorable safety and toxicology profile, allowing ITMN-191 to be studied in clinical trials over a range of doses predicted to have antiviral efficacy. ITMN-191 has also demonstrated high in vitro potency and specificity in biochemical assays and in assays utilizing the HCV replicon system. Moreover, ITMN-191 displays a favorable cross-resistance profile, including significant potency against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. The preclinical pharmacokinetic results reported in the CTA support the exploration of twice-daily dosing in the treatment of chronic hepatitis C.

The CTA also describes the successful GMP manufacture of multiple lots of ITMN-191 drug substance and development of an ITMN-191 drug product formulation, which is intended to be used in the Phase I clinical development program.

"We are very pleased to have submitted the CTA for ITMN-191 on the schedule we set last January," said Dan Welch, President and CEO of InterMune. "This is the first time InterMune has advanced a compound from early discovery to the submission of an electronic CTA, a notable achievement. We look forward to securing the authorization to proceed with our first clinical trial of ITMN-191, which we anticipate to begin before the end of this year."

About HCV and HCV Protease Inhibitors

According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. HCV protease inhibitors represent a promising class of drugs for HCV, and the HCV NS3/4A protease is an attractive drug target because of its involvement in viral replication and suppressive effects on host response to viral invasion.