Below is a press release from Intermune, the company that makes Pirfenidone. Not only is this drug being tried for idiopathic pulmonary fibrosis but also for the pulmonary fibrosis of Hermansky-Pudlak Syndrome. Just as good news from our trial is good news for the greater pulmonary fibrosis community, so is good news about their trial also good news for us. The sooner this drug is available for those that need it, the better.
InterMune Completes Patient Enrollment in Phase 3 'Capacity' Program Evaluating Pirfenidone in Patients With IPF
BRISBANE, Calif., May 16 /PRNewswire-FirstCall/ -- InterMune, Inc.
(Nasdaq: ITMN) today announced that patient enrollment has been completed
in CAPACITY, the company's Phase 3 clinical program to evaluate pirfenidone
as a treatment for patients with idiopathic pulmonary fibrosis (IPF).
"We are very pleased to have completed enrollment of the CAPACITY
program seven months ahead of the original schedule, and with 194 more
patients than originally planned," said Steve Porter, M.D., Ph.D. and Chief
Medical Officer of InterMune. "The rapid pace of enrollment clearly
reflects strong interest by investigators and patients. We look forward to
sharing top-line results from CAPACITY, which are now expected to be
available around the end of 2008."
The CAPACITY program includes two multinational, randomized,
double-blind, placebo controlled Phase 3 trials, named CAPACITY 1 and
CAPACITY 2, designed to evaluate the safety and efficacy of pirfenidone in
IPF patients with mild to moderate impairment in lung function. The primary
endpoint of both trials is lung function, as measured by change in forced
vital capacity (FVC). The two trials have enrolled a total of 779 patients
at 110 centers in North America and Europe. Enrollment was completed in
less than 13 months following randomization of the first patient into the
program in late April 2006.
InterMune noted that the design of the Phase 3 CAPACITY program
reflects the following data and information:
-- In March of 2007, Shionogi and Co., Ltd. reported that in its Phase 3
trial of pirfenidone in IPF in Japan, the primary efficacy endpoint,
change in vital capacity (VC), was met with statistical significance in
both the high-dose and low-dose treatment groups compared to placebo,
representing 44% and 50% relative reductions in VC decline,
respectively, over 52 weeks;
-- InterMune's CAPACITY program has greater than 95% power to detect a 50%
reduction in the rate of FVC progression and greater than 85% power to
detect a 40% reduction after 72 weeks of treatment, compared to
placebo;
-- An understanding of the natural history of the disease based on
observed changes in forced vital capacity (FVC) and other important
measures of lung function over time in the placebo group of the
recently un-blinded INSPIRE trial of Actimmune(R) in IPF informed the
assumptions of FVC decline of the placebo group in CAPACITY;
-- Pirfenidone appears to have a positive effect on lung function,
measured by VC or FVC, as suggested in several Phase 2 studies as well
as the Shionogi Phase 3 study; and
-- FVC as the primary endpoint of CAPACITY is supported by the FDA and the
EMEA.
"Study conduct in CAPACITY has been excellent, as we have experienced a
very low patient drop-out rate to date with over 750 patients enrolled and
having conducted the program for more than one year," Dr. Porter added. "A
well-designed and well-powered study, combined with excellent study
conduct, provide confidence that we are well positioned to determine the
extent to which pirfenidone can fill the significant unmet medical need for
a new medicine to help patients suffering from IPF."
A Significant Unmet Medical Need
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal
disease that affects approximately 83,000 people in the United States, with
approximately 30,000 new cases developing each year. There are no drugs
approved by the FDA or EMEA for the treatment of IPF. By comparison, each
year there are approximately 5,000 to 6,000 new diagnoses of pulmonary
arterial hypertension, approximately 10,000 patients diagnosed with
multiple sclerosis and about 26,000 patients diagnosed with ovarian cancer.
Each of these supports pharmaceutical markets valued at over one billion
dollars in annual revenue.
About IPF
IPF is characterized by inflammation and scarring (fibrosis) in the
lungs, hindering the ability to process oxygen and causing shortness of
breath (dyspnea) and cough. IPF is a progressive disease, meaning that over
time, lung scarring and symptoms increase in severity. The median survival
time from diagnosis is two to five years, with a five-year survival rate of
approximately 20%. Patients diagnosed with IPF are usually between the ages
of 40 and 70, and the disease tends to affect men more than women.
About Pirfenidone
Prior in vitro evidence has shown that pirfenidone inhibits collagen
synthesis, down-regulates profibrotic cytokines and decreases fibroblast
proliferation. Data presented from one Phase 3 study and four Phase 2
clinical trials in more than 400 patients suggest that pirfenidone may
positively affect lung function and disease progression in patients with
IPF. In these clinical studies, pirfenidone was generally well tolerated
with the most frequent side effects reported being photosensitivity rash
and gastrointestinal symptoms. Both the U.S. Food and Drug Administration
(FDA) and European Medicines Evaluation Agency (EMEA) have granted
pirfenidone orphan drug designation for the treatment of IPF. InterMune has
worldwide rights, excluding Japan, Korea and Taiwan, to develop and
commercialize pirfenidone for all fibrotic diseases. Pirfenidone is
un-partnered at this time.
About InterMune
InterMune is a biotechnology company focused on the research,
development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a portfolio of compounds addressing
idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections.
The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is
evaluating pirfenidone as a possible therapeutic candidate for the
treatment of patients with IPF and a research program focused on small
molecules for pulmonary disease. The hepatology portfolio includes the HCV
protease inhibitor compound ITMN-191 in Phase 1a, a second-generation HCV
protease inhibitor program, and a research program evaluating a new target
in hepatology. For additional information about InterMune and its R&D
pipeline, please visit http://www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of section 21E of the Securities Exchange Act of 1934, as amended,
that reflect InterMune's judgment and involve risks and uncertainties as of
the date of this release, including without limitation the statements
related to anticipated future financial results and product development.
All forward- looking statements and other information included in this
press release are based on information available to InterMune as of the
date hereof, and InterMune assumes no obligation to update any such
forward-looking statements or information. InterMune's actual results could
differ materially from those described in InterMune's forward-looking
statements.
Factors that could cause or contribute to such differences include, but
are not limited to, those discussed in detail under the heading "Risk
Factors" in InterMune's most recent annual report on Form 10-K filed with
the SEC on March 30, 2007 (the "Form 10-K") and other periodic reports
filed with the SEC, including the following: (i) risks related to the
uncertain, lengthy and expensive clinical development and regulatory
process, including having no unexpected safety, toxicology, clinical or
other issues; (ii) risks related to achieving positive clinical trial
results; (iii) risks related to timely patient enrollment and retention in
clinical trials; (iv) the results of the InterMune CAPACITY trials of
pirfenidone may differ materially from those of the Shionogi & Co., Ltd.
Phase 3 trial of pirfenidone; and (v) the results as reported by Shionogi
concerning their Phase 3 trial may differ from those published or presented
in a peer-reviewed forum. The risks and other factors discussed above
should be considered only in connection with the fully discussed risks and
other factors discussed in detail in the Form 10-K and InterMune's other
periodic reports filed with the SEC, all of which are available via
InterMune's web site at http://www.intermune.com.
InterMune Completes Patient Enrollment in Phase 3 'Capacity' Program Evaluating Pirfenidone in Patients With IPF
BRISBANE, Calif., May 16 /PRNewswire-FirstCall/ -- InterMune, Inc.
(Nasdaq: ITMN) today announced that patient enrollment has been completed
in CAPACITY, the company's Phase 3 clinical program to evaluate pirfenidone
as a treatment for patients with idiopathic pulmonary fibrosis (IPF).
"We are very pleased to have completed enrollment of the CAPACITY
program seven months ahead of the original schedule, and with 194 more
patients than originally planned," said Steve Porter, M.D., Ph.D. and Chief
Medical Officer of InterMune. "The rapid pace of enrollment clearly
reflects strong interest by investigators and patients. We look forward to
sharing top-line results from CAPACITY, which are now expected to be
available around the end of 2008."
The CAPACITY program includes two multinational, randomized,
double-blind, placebo controlled Phase 3 trials, named CAPACITY 1 and
CAPACITY 2, designed to evaluate the safety and efficacy of pirfenidone in
IPF patients with mild to moderate impairment in lung function. The primary
endpoint of both trials is lung function, as measured by change in forced
vital capacity (FVC). The two trials have enrolled a total of 779 patients
at 110 centers in North America and Europe. Enrollment was completed in
less than 13 months following randomization of the first patient into the
program in late April 2006.
InterMune noted that the design of the Phase 3 CAPACITY program
reflects the following data and information:
-- In March of 2007, Shionogi and Co., Ltd. reported that in its Phase 3
trial of pirfenidone in IPF in Japan, the primary efficacy endpoint,
change in vital capacity (VC), was met with statistical significance in
both the high-dose and low-dose treatment groups compared to placebo,
representing 44% and 50% relative reductions in VC decline,
respectively, over 52 weeks;
-- InterMune's CAPACITY program has greater than 95% power to detect a 50%
reduction in the rate of FVC progression and greater than 85% power to
detect a 40% reduction after 72 weeks of treatment, compared to
placebo;
-- An understanding of the natural history of the disease based on
observed changes in forced vital capacity (FVC) and other important
measures of lung function over time in the placebo group of the
recently un-blinded INSPIRE trial of Actimmune(R) in IPF informed the
assumptions of FVC decline of the placebo group in CAPACITY;
-- Pirfenidone appears to have a positive effect on lung function,
measured by VC or FVC, as suggested in several Phase 2 studies as well
as the Shionogi Phase 3 study; and
-- FVC as the primary endpoint of CAPACITY is supported by the FDA and the
EMEA.
"Study conduct in CAPACITY has been excellent, as we have experienced a
very low patient drop-out rate to date with over 750 patients enrolled and
having conducted the program for more than one year," Dr. Porter added. "A
well-designed and well-powered study, combined with excellent study
conduct, provide confidence that we are well positioned to determine the
extent to which pirfenidone can fill the significant unmet medical need for
a new medicine to help patients suffering from IPF."
A Significant Unmet Medical Need
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal
disease that affects approximately 83,000 people in the United States, with
approximately 30,000 new cases developing each year. There are no drugs
approved by the FDA or EMEA for the treatment of IPF. By comparison, each
year there are approximately 5,000 to 6,000 new diagnoses of pulmonary
arterial hypertension, approximately 10,000 patients diagnosed with
multiple sclerosis and about 26,000 patients diagnosed with ovarian cancer.
Each of these supports pharmaceutical markets valued at over one billion
dollars in annual revenue.
About IPF
IPF is characterized by inflammation and scarring (fibrosis) in the
lungs, hindering the ability to process oxygen and causing shortness of
breath (dyspnea) and cough. IPF is a progressive disease, meaning that over
time, lung scarring and symptoms increase in severity. The median survival
time from diagnosis is two to five years, with a five-year survival rate of
approximately 20%. Patients diagnosed with IPF are usually between the ages
of 40 and 70, and the disease tends to affect men more than women.
About Pirfenidone
Prior in vitro evidence has shown that pirfenidone inhibits collagen
synthesis, down-regulates profibrotic cytokines and decreases fibroblast
proliferation. Data presented from one Phase 3 study and four Phase 2
clinical trials in more than 400 patients suggest that pirfenidone may
positively affect lung function and disease progression in patients with
IPF. In these clinical studies, pirfenidone was generally well tolerated
with the most frequent side effects reported being photosensitivity rash
and gastrointestinal symptoms. Both the U.S. Food and Drug Administration
(FDA) and European Medicines Evaluation Agency (EMEA) have granted
pirfenidone orphan drug designation for the treatment of IPF. InterMune has
worldwide rights, excluding Japan, Korea and Taiwan, to develop and
commercialize pirfenidone for all fibrotic diseases. Pirfenidone is
un-partnered at this time.
About InterMune
InterMune is a biotechnology company focused on the research,
development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a portfolio of compounds addressing
idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections.
The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is
evaluating pirfenidone as a possible therapeutic candidate for the
treatment of patients with IPF and a research program focused on small
molecules for pulmonary disease. The hepatology portfolio includes the HCV
protease inhibitor compound ITMN-191 in Phase 1a, a second-generation HCV
protease inhibitor program, and a research program evaluating a new target
in hepatology. For additional information about InterMune and its R&D
pipeline, please visit http://www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of section 21E of the Securities Exchange Act of 1934, as amended,
that reflect InterMune's judgment and involve risks and uncertainties as of
the date of this release, including without limitation the statements
related to anticipated future financial results and product development.
All forward- looking statements and other information included in this
press release are based on information available to InterMune as of the
date hereof, and InterMune assumes no obligation to update any such
forward-looking statements or information. InterMune's actual results could
differ materially from those described in InterMune's forward-looking
statements.
Factors that could cause or contribute to such differences include, but
are not limited to, those discussed in detail under the heading "Risk
Factors" in InterMune's most recent annual report on Form 10-K filed with
the SEC on March 30, 2007 (the "Form 10-K") and other periodic reports
filed with the SEC, including the following: (i) risks related to the
uncertain, lengthy and expensive clinical development and regulatory
process, including having no unexpected safety, toxicology, clinical or
other issues; (ii) risks related to achieving positive clinical trial
results; (iii) risks related to timely patient enrollment and retention in
clinical trials; (iv) the results of the InterMune CAPACITY trials of
pirfenidone may differ materially from those of the Shionogi & Co., Ltd.
Phase 3 trial of pirfenidone; and (v) the results as reported by Shionogi
concerning their Phase 3 trial may differ from those published or presented
in a peer-reviewed forum. The risks and other factors discussed above
should be considered only in connection with the fully discussed risks and
other factors discussed in detail in the Form 10-K and InterMune's other
periodic reports filed with the SEC, all of which are available via
InterMune's web site at http://www.intermune.com.
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