Immunitor Releases Positive Results of TB Immunotherapy From Its Second Clinical Site
24 Gennaio 2011 - 10:43AM
Immune Network Ltd., (Pink Sheets:IMMFF) a company in the business
of development and commercialization of immune therapies, announced
today that its newly acquired business, Immunitor Inc., has
published interim data from the ongoing Phase IIb
imm01 clinical trial of V5 in tuberculosis
(including multidrug resistant TB, MDR-TB) conducted at its second
site in Ukraine. The results from the Department of Phtysiatry and
Pulmonology of Kharkov Medical University appeared in peer-reviewed
Journal of Immune Based Therapies and Vaccines - an open access
journal from BioMed Central
(http://www.jibtherapies.com/content/9/1/3/abstract). The principal
investigator of the study is Professor Svetlana Zaitzeva – an
established expert in immunotherapy of tuberculosis (TB) and the
editor of the authoritative book "Phtysiatry".
Mycobacterium tuberculosis -- already infecting the global
population at the rate of one new case per second -- is one of the
most dangerous infections, second after HIV. While the World Health
Organization (WHO) estimates that one-third of the global
population may currently have the bacterium that causes TB, the
treatment -- a yearlong regimen of drugs developed more than four
decades ago -- is failing, especially with multi-drug
resistant TB and TB/HIV cases. Historically TB has been considered
a "neglected disease" -- disease into which pharmaceutical
companies have been reluctant to invest due to a perception of low
commercial potential. The lack of interest from the industry
combined with indifference of non-profit funding agencies recently
made the WHO warn that a shortage of money could limit the progress
in winning the war against TB. Dr Margaret Chan, the Director
General of the WHO, said, "Many organizations in global health,
like the Global Fund, the GAVI Alliance, and WHO itself, now face
serious funding shortfalls." The current pipeline of TB drugs is
limited and redundant; thus, radical new approaches are needed,
including allocation of more funds into conceptually novel
therapeutics and vaccines. "The money is not the only barrier, the
main problem is that the public and physicians are not yet ready to
embrace the concept of immune therapy of TB," says Aldar
Bourinbaiar, the CEO of Immunitor.
The study has shown that V5 is safe, ameliorates symptoms of TB
and improves quality of life. Outstanding efficacy after just 1
month of treatment was observed, including in MDR-TB patients, with
conversion rate of sputum smear of 78.3% vs 0% in the placebo
group. Scoring of sputum bacillary load at baseline and
post-treatment revealed score reduction in 23 out of 24 (95.8%) V5
recipients (P=6E-010) but only in 1 out of 10 patients on placebo
(P=0.34). Remarkably, one-month sputum conversion rate among
patients with MDR-TB was the same as for drug-sensitive,
first-diagnosed TB. The immunotherapy has shown clear benefit in
reversing body weight loss. The average gain in V5 and placebo
groups was 3.5 kg and 0.9 kg which is almost identical to the
results of earlier published placebo-controlled trial involving a
comparable group of 55 TB patients from the first clinical site at
Lisichansk TB Dispensary. TB is a chronic inflammatory disease and
immunologically resembles AIDS and hepatitis – diseases that are
also characterized by persistent inflammation. The study confirmed
earlier observations that V5 displays anti-inflammatory activity.
Elevated leukocyte counts that are traditionally associated with
inflammation were normalized in V5-treated patients (P=0.002) but
not in the placebo group (P=0.43). Another marker of inflammation,
the erythrocyte sedimentation rate (ESR), declined significantly in
V5 group (P=8E-007) but was unchanged in placebo recipients
(P=0.61). V5 was perfectly compatible with TB drugs and had a
significant impact in reducing their hepatotoxicity.
"Immunitor's oral biologicals delivery platform is now being
applied to other complex chronic medical conditions such as cancer
and cardiovascular and metabolic diseases like atherosclerosis and
obesity," said Vichai Jirathitikal – co-founder of Immunitor. "It's
a question of time to convince healthcare providers that there are
opportunities that will protect their patients much better than
they are today," Vichai said. "The bottom line," he adds, "is that
V5 is safe and effective, very simple to use requiring only one
pill per day, unlike other vaccines can be kept at room temperature
without refrigeration, and above all, is affordable, eliminating
the need for more expensive second-line TB drugs. These advantages
are essential for deploying V5 in developing countries in Africa as
well as Asia, including India and China. We are excited that V5 can
shorten treatment duration down to one month, as Zaitzeva and her
team have convincingly shown in their study."
Considering that 2 billion people are latently infected with M.
tuberculosis, it is likely that two different types of prophylactic
TB vaccines will be needed: one is a so-called pre-exposure vaccine
to prevent mycobacterial infection in naive, non-infected
individuals and second, post-exposure vaccine, to prevent TB
disease in tubercle bacilli carriers without exacerbating disease
manifestations. Up to now, the majority of vaccine candidates are
in the first category and only Mycobacterium vaccae and RUTI are
considered to be in the second category. Studying V5 as a
post-exposure vaccine can contribute to better understanding of the
immunopathogenesis of TB resulting in the design of effective
vaccines. In addition, V5 studies can yield important insights into
correlates of immune protection, which are still poorly understood.
For more information, please visit http://www.immunitor.com.
The Immune Network Ltd logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8008
Further information is available on the web for Immune Network
Ltd. (www.immune-network.com)
Forward-Looking Statements
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development and capabilities of Immune Network technologies or that
otherwise relate to future periods are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These
statements are based on assumptions that may not prove accurate.
Actual results could differ materially from those anticipated due
to certain risks inherent in the biotechnology industry and for
companies engaged in the development of new products in a regulated
market.
CONTACT: Immune Network Ltd.
immff@yahoo.com
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