Update From Fred

[Guest guest]

January 10, 2005

New Hepatitis C Drug (NM283) Clinical Trial Report

This is a report on yet another new drug for the treatment of

Hepatitis C. The exciting news for most patients in the US, Europe

and Japan is that this drug is specifically targeted toward genotype

1. Genotype 1 is the most common genotype in these areas and is also

the hardest to treat with current therapy.

Pharmaceutical companies are rushing to develop new and better

treatments for Hepatitis C because they see huge profits. They know

that current therapy is inadequate or inappropriate for most

patients in the US, Europe and Japan. Ultimately, the greed of the

pharma companies works to our benefit.

Incidentally, the results of this trial are apparently very good.

Press Release Source: Idenix Pharmaceuticals, Inc.

Idenix Reports Interim Analysis of a Phase IIa Clinical Trial of

Valopicitabine (NM283) in Combination with Pegylated Interferon in

Treatment-Naive Hepatitis C Genotype 1 Patients

Monday January 10, 8:30 am ET

Patients receiving the combination treatment achieved a mean viral

load reduction of 3.2 log10, or 99.94 percent, after 12 weeks of

treatment

SAN FRANCISCO, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Idenix

Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical

company engaged in the discovery and development of drugs for the

treatment of human viral and other infectious diseases, today

announced interim clinical trial data for valopicitabine (NM283),

the company's lead drug candidate for the treatment of hepatitis C.

In this phase IIa trial, patients are randomized to one of two

treatment arms, valopicitabine (NM283) monotherapy, or

valopicitabine (NM283) plus pegylated interferon. This interim data

analysis includes all 19 patients who have completed 12 weeks of

treatment in this trial. The patients receiving the combination of

NM283 and pegylated interferon achieved a mean reduction of serum

HCV RNA of 3.2 log10, or 99.94 percent, at week 12.

These data will be included in the company's presentation at the

JP Healthcare Conference on Wednesday, January 12, 2005 at

8:30 a.m. in San Francisco.

" In patients infected with HCV genotype 1 -- a difficult-to-treat

strain of hepatitis C virus and the most prevalent strain in the

U.S., Western Europe and Japan -- virologic response to the current

standard therapy of ribavirin and interferon is inconsistent, "

commented iel Brown, M.D., Idenix's executive vice president,

clinical development and chief medical officer. " However, the

consistency of response to the combination of valopicitabine and

interferon appears promising: eleven of twelve patients receiving

this combination treatment had significant HCV RNA reductions of 1.7

to 6.2 log10 by week 12.

Based on these encouraging interim data, we have extended this phase

IIa trial to 6 months in order to investigate longer duration

treatment. " Phase IIa Trial Design and 12 Week Interim Results:

Idenix will enroll a total of 30 patients in the phase IIa clinical

trial, which is designed to assess the safety, antiviral activity

and pharmacokinetics of the combination of NM283 and pegylated

interferon compared to NM283 alone.

Key entry criteria for this clinical trial include treatment-naive

patients with HCV genotype 1, baseline viral load greater than 5

log10 copies/ml and alanine aminotransferase (ALT) levels less than

5 times the upper limit of normal.

In this phase IIa clinical trial, patients are being randomized to

one of two treatment arms so that 12 patients will receive NM283

monotherapy and 18 patients will receive NM283 plus pegylated

interferon. After 12 weeks of treatment, mean HCV RNA reductions

from baseline were 0.9 log10 IU/mL, or 87.4 percent, for the 7

patients in the NM283 monotherapy group, and 3.2 log10 IU/mL, or

99.94 percent, for the 12 patients in the combination treatment

group. Nine of twelve patients receiving combination treatment have

achieved an early viral response with a greater than 2 log10

decrease in levels of HCV RNA at week 12.

Tolerance of both treatment regimens has been satisfactory to date,

with no serious adverse events. Four- week data from these same 19

patients were presented by Dr. Nezam Afdhal at the American

Association for the Study of Liver Diseases' annual meeting in

November 2004.

Hepatitis C Development Program

Idenix's hepatitis C development program is initially seeking to

address the large patient population that has failed to respond to

the current standard treatment, pegylated interferon plus ribavirin,

and for whom no other treatment option is currently available.

Idenix expects to subsequently target the treatment-naive patient

population for whom treatment with the current standard of care is

only successful in approximately 50% of patients.

" Hepatitis C patients confront many unmet treatment needs, with

several hundred thousand having failed prior treatment with no

therapeutic options, and millions of people infected with difficult

to treat strains of HCV, " said Jean-Pierre Sommadossi, Ph.D.,

Idenix's chairman and chief executive officer. " Idenix is committed

to rapidly advancing the NM283 clinical program, which seeks to

address the medical needs of all individuals infected with hepatitis

C. "

Development for Treatment-failure Patients: Idenix has initiated a

phase IIb clinical trial for NM283 in patients who have previously

failed treatment with pegylated-interferon and ribavirin and expects

to begin enrolling patients in this study in early 2005. The company

anticipates that this 6- month head-to-head trial, comparing the

combination of NM283 plus pegylated interferon to the current

standard therapy (ribavirin plus pegylated interferon), will enroll

approximately 170 HCV genotype 1 patients who have previously failed

at least 3 months of treatment with current standard therapy.

This phase IIb clinical trial will also include a monotherapy arm of

NM283. Development for Treatment-naive Patients: Encouraging results

from the ongoing phase IIa clinical trial, summarized above, will

support initiation of a larger phase IIb clinical trial of

valopicitabine (NM283) in combination with pegylated interferon in

treatment-naove patients, the majority of whom are expected to be

infected with HCV genotype 1. Idenix anticipates beginning this

trial in mid-2005.

About Valopicitabine (NM283)

Valopicitabine (NM283) is an oral, novel nucleoside analog that was

co- discovered by Idenix and the University of Cagliari through a

cooperative laboratory agreement under the direction of Dr. Paolo

LaColla, Director of the Department of Biomedical Sciences and

Technologies of the University. Valopicitabine (NM283) is being

developed in combination with pegylated interferon. To date,

valopicitabine (NM283) has demonstrated a satisfactory safety

profile with mild to moderate gastrointestinal side effects and no

treatment-related discontinuations.

About Hepatitis C

There are approximately 170 million people worldwide with chronic

HCV infection, of which approximately 2.7 million are in the United

States. Chronic HCV infection accounts for 40 percent of end-stage

cirrhosis, 60 percent of liver cancer and 30 to 40 percent of liver

transplants in the United States and other industrialized countries.

Responses to current treatment options are frequently inadequate due

to the inability of some patients to tolerate these treatments and

by their limited effectiveness, particularly in patients infected

with HCV genotype 1.

The genotype 1 strain of HCV is the most treatment-resistant HCV

genotype and is estimated to cause more than 70 percent of the

reported cases of hepatitis C in the U.S. and Japan, and more than

65% of the reported cases of hepatitis C in Western Europe.

About Idenix

Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged

in the discovery and development of drugs for the treatment of human

viral and other infectious diseases. Idenix's current focus is on

the treatment of infections caused by hepatitis B virus, hepatitis C

virus and human immunodeficiency virus (HIV).

Idenix's headquarters are located in Cambridge, Massachusetts and it

has drug discovery operations in Montpellier, France and Cagliari,

Italy. For further information about Idenix, please refer to

http://www.idenix.com.

Forward-looking Statements

This press release contains " forward-looking statements " within the

meaning of the Private Securities Litigation Act of 1995. Statements

in this press release other than those that are historical in nature

are " forward- looking statements. "

Such forward looking statements, which include statements with

respect to the potential therapeutic benefits and successful

development of the company's drug candidates and the company's drug

discovery, research and clinical development activities, are subject

to numerous factors, risks and uncertainties that may cause actual

events or results to differ materially from the company's current

expectations. These risks and uncertainties relate to the results of

clinical trials and other studies with respect to the drug

candidates that the company has under development; the timing and

success of submission, acceptance and approval of regulatory

filings; the company's dependence on its collaboration with Novartis

Pharma AG; the company's ability to obtain additional funding

required to conduct its research, development and commercialization

activities; the ability of the company to attract and retain

qualified personnel, and the company's ability to obtain, maintain

and enforce patent and other intellectual property protection for

its drug candidates and its discoveries.

These and other risks are described in greater detail in the " Risk

Factors " section of the company's quarterly report on Form 10-Q for

the quarter ended September 30, 2004 and filed with the Securities

and Exchange Commission and other filings that the company makes

with the Securities and Exchange Commission.

All forward-looking statements reflect the company's expectations

only as of the date of this release and should not be relied upon as

reflecting the company's views, expectations or beliefs at any date

subsequent to the date of this release. Idenix anticipates that

subsequent events and developments may cause these views,

expectations and beliefs to change. However, while Idenix may elect

to update these forward-looking statements at some point in the

future, it specifically disclaims any obligation to do so.

Posted by Ralph at January 10, 2005 10:14 AM

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