Immunitor Phase 2b imm01 Trial Enrollment Scheduled to Complete Next Week
01 Novembro 2010 - 11:42AM
Immune Network Ltd. (Pink Sheets:IMMFF), a company in the business
of discovery and development of immune-based therapies, today
announced that patient enrollment will be completed next week for
the company's future partner Immunitor's Phase 2b imm01 trial of V5
immunotherapy in 120 patients with tuberculosis. V5 is an orally
delivered once-daily tablet that in combination with standard TB
drugs had so far produced clearance of Mycobacterium tuberculosis
in sputum smear of about 95% of treated TB patients within one
month.
M. tuberculosis is the cause of the second-most, after HIV,
lethal infectious disease in the world. The usual duration of
therapy with current TB drugs is 6-9 months or longer which can
produce mycobacterial clearance in over 85% of patients. Currently
available TB chemotherapy is not perfect; it requires several TB
drugs to be taken in combination for long periods of time. This can
cause multiple side effects, poor drug compliance, treatment
failure, and the emergence of drug resistance with major social and
economic consequences, especially in low-income countries in Asia,
Africa, India and Eastern Europe where TB is rampant. Almost 9
million people develop TB and nearly two million people die
annually. TB is increasingly untreatable due to antibiotic
resistant strains that are especially dangerous to HIV positive
people – killing 500,000 each year. The discovery of antibiotics
revolutionized the treatment of TB and saved millions of lives. But
they are losing effectiveness as the mycobacteria have become
resistant to them. In the past 30 years only two new classes of
antibacterials have been developed. It is clear that novel
immune-based therapies and TB vaccines are urgently needed to
complement antitubercular drug discovery.
The Phase 2b imm01 trial follows the recent publication in
Journal of Vaccines & Vaccination of positive results from open
label Phase 2 trial in 20 patients with TB who simultaneously had
HIV and hepatitis C virus (HCV) co-infections
(http://omicsonline.org/2157-7560/2157-7560-1-103.php). The imm01
study for which enrollment is being completed is designed to gain
additional information on V5 efficacy against multi-drug-resistant
TB (MDR-TB) and explore further dually infected TB/HIV individuals.
In addition to anti-TB activity, the imm01 study will evaluate the
impact on biomarkers of inflammation, reduction of fever, reversal
of anemia and wasting, and other common TB symptoms as well as
safety. So far 90 patients were enrolled and randomized in a 1:1
ratio to receive two months treatment with either once-per-day
tablet of V5 or placebo, along with the standard of care TB drugs.
After two months, patients in the active treatment arm and in
placebo group will be compared and treatment will be continued for
those who were not cured according to the WHO-recommended DOT
strategy. Immunitor anticipates reporting preliminary results in
February 2011 from a planned interim analysis of the first month of
treatment from 2-month trial. Further information about imm01 trial
is available at http://clinicaltrials.gov/ct2/show/NCT01222338
"The completion of enrollment in the Phase 2b study of V5 is an
important step forward for Immunitor, and for our future partner
Immune Network, in the joint effort to develop a potentially
disease-curing medicine for "regular" TB as well as for more
difficult-to-treat TB forms like MDR-TB and XDR-TB or the deadly
duo TB/HIV co-infection," said Aldar Bourinbaiar, Immunitor's Chief
Executive Officer. "V5 was originally designed for management of
hepatitis B and C chronic viral diseases, but then we accidentally
discovered its anti-TB activity," added Vichai Jirathitikal,
Immunitor's co-founder and co-developer of the vaccine. "Based on
what we know, we have very high level of confidence that V5 has the
potential to provide patients an entirely new approach to
controlling their chronic infectious diseases." In addition to V5,
the company has demonstrated the potential of its oral vaccine
platform in published studies for HIV indication, pandemic
influenza, atherosclerosis and obesity. Immunitor's pipeline has
other products currently under investigation, which include
immunotherapies for a broad spectrum fungal and bacterial
infections, malaria, autoimmune and inflammatory diseases, and
cancer. For more information, please visit
http://www.immunitor.com.
Forward-Looking Statements
Safe Harbor Statement
The information in this release, other than historical
information, may be considered forward-looking statements within
the provisions of the Private Securities Litigation Reform Act of
1995. Projection and other forward-looking statements and
management expectations regarding future events and/or financial
performance of the Company – although given in good faith – are
inherently uncertain and actual events and/or results may differ
materially.
Further information is available on the web for Immune Network
Ltd. (www.immune-network.com)
The Immune Network Ltd logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8008
CONTACT: Immune Network Ltd.
immff@yahoo.com
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