Immunitor Publishes Interim Data From Phase IIb imm01 TB Trial
30 Dezembro 2010 - 7:41AM
Immune Network Ltd. (Pink Sheets:IMMFF), advises that Immunitor has
published data from the first half of the 120-patient imm01
clinical trial of its V5 immunomodulator product against
tuberculosis, including difficult-to-treat forms of the disease
(http://clinicaltrials.gov/ct2/show/NCT01222338).
The article entitled "Adjunct oral immunotherapy in patients
with re-treated, multidrug-resistant or HIV-coinfected TB" appeared
as e-publication ahead of print in the peer-reviewed, high-impact,
Immunotherapy journal. The link to the abstract of paper is
available at http://www.ncbi.nlm.nih.gov/pubmed/21182457.
The study, which was conducted by internationally recognized
experts in the field of TB immunotherapy, Dr. Olga Arjanova and her
team at Lisichansk TB Dispensary in the Eastern Ukraine, aimed to
compare the impact of V5 immunotherapy to placebo among treatment
refractory tuberculosis cases including re-treated TB, multi-drug
resistant (MDR-TB) and TB with HIV co-infection.
The results of the newly published study support findings from
the earlier published open label trial that appeared in October of
this year in the Journal of Vaccines and Vaccination and provide
further evidence of safety and clinical efficacy of V5.
The imm01 study indicated that V5 was safe, has not produced any
adverse effects or reactivation of TB. Concurrent administration of
V5 either with 1st- or 2nd-line TB drugs resulted in clearance of
M. tuberculosis in sputum smears of 96.3% patients as opposed to
25% among placebo recipients. Sputum conversion occurred very
quickly - only one month of treatment was needed. No difference was
seen when "regular" easy-to-treat TB was compared to re-treated TB,
MDR-TB or HIV-TB - the proportion of converted patients and time to
conversion were identical. Another significant observation worthy
of note is that the outcome appeared to be the same, regardless
whether 1st line or 2nd line TB drugs were used.
One pill of Immunitor's V5 given once-per-day produced other
statistically significant clinical benefits. V5 reversed
TB-associated wasting: average weight gain was 3.4 kg in 100% of V5
patients vs. 1.07 kg in 67.9% of placebo patients. V5 also
eliminated TB-associated fever in 100% vs. 39.3% of patients on
placebo. Finally, V5 showed marked anti-inflammatory effect:
erythrocyte sedimentation rate and leukocyte counts reverted back
to within normal range in patients taking the Immunitor product.
The relationship between anti-inflammatory property of V5 and
bacterial clearance needs to be investigated further.
In addition to the anti-tuberculosis and positive clinical
effects, Immunitor's V5 immunomodulator is also shown to reduce the
hepatotoxicity induced by chemotherapy for TB, MDR-TB and XDR-TB.
The serious adverse effects of TB drugs have important negative
consequences on treatment options, not only causing direct damage
to patient health but also decreasing the willingness of patients
to comply with their TB treatment regimen.
Addition of V5 has been shown to counter the hepatotoxicity of
TB drugs. For this reason the combination of V5 with ATT
(anti-tuberculosis therapy) has an additional benefit of preventing
or reversing drug-induced liver damage.
"Remarkable anti-TB activity was discovered accidentally during
clinical trial in patients with chronic hepatitis C who also
happened to have Mycobacterium tuberculosis and HIV co-infections,"
said Aldar Bourinbaiar, CEO of Immunitor company. "The goal of
Immunitor is to investigate in depth the properties of V5 and, in
so doing, eventually develop a vaccine that could do both, treat
and prevent TB."
After AIDS, tuberculosis is the second most common cause of
death from an infectious disease, with approximately 2 million
people dying each year. Current treatments are not fully effective,
particularly against multi-drug resistant TB (MDR-TB) and HIV-TB
and strenuous treatment regimens lasting for up to 2 years are
required. "Immunitor's approach has the potential to address
current challenges – offering a drastically shorter, more
efficacious and safer treatment solution. In addition, V5 is
inexpensive; easy to administer; stable at tropical temperatures;
and is made from readily available sources, which suits ideally
developing countries where TB is rampant and patients are too poor
to afford expensive 2nd line TB drugs," said Vichai Jirathitikal,
co-founder and co-inventor of Immunitor oral vaccine platform. For
additional information about Immunitor company, please visit
www.immunitor.com.
Immune Network is in the final stages of its work toward meeting
the conditions for a merger or other transaction. Additional
corporate details and terms for the transaction with Immunitor will
be announced shortly. A temporary website for Immune Network is at
http://www.immune-network.com.
The Immune Network Ltd. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8008
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.
CONTACT: Immune Network Ltd
IMMFF@yahoo.com
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