Exhibit 10.13
AGREEMENT FOR JOINT CLINICAL INVESTIGATIONS
Both sides note that the first treatment of autoimmune diseases by removal of
interferons (cytokines) was proposed in 1974 by Xxxxxxxxx X.X. Xxxxxxxxxx
(Nature, 1974;247:551-2). He also proposed to remove TNF-(alpha) in various
autoimmune conditions, including AIDS (J IFN & Cytokine Res 1989;9:S2 and other
publications and patents). The use of anticytokines in autoimmune conditions has
received wide experimental and clinical confirmation in various laboratories of
the world. As is known, organ transplant rejection is also connected with
autoimmune mechanisms. In joint investigations positive results were obtained
with the use of antibodies to interferon-(gamma) in corneal transplants
(Treatment of corneal transplant rejection in humans with
anti-interferon-(gamma) antibodies,. Am J Opthalmol 2002;133:829-30).
Based on this, the State Institute of Transplantation and Artificial Organs of
the Ministry of Health of the Russian Federation ("Institute" herein) in the
person of the Academician Russian Medical and Xxxxxxxxx Xxxxxx Xxxxxxxxx
Xxxxxxxx and Advanced Biotherapy, Inc. (ABI- USA) in the person of Xxxxxxxxx
X.X. Xxxxxxxxxx, vice-president of ABI, agree to conduct joint clinical
investigations on the reduction or prevention of organ transplant rejection by
anticytokine therapy. In our joint investigation mainly anti-interferon-(gamma)
antibodies will be used after transplantation of the heart, lung, liver, or
pancreatic beta-islet cells.
Treatment of other conditions besides transplantation is possible.
ABI will supply the Institute with antibodies to interferon g and antibodies to
TNIF-(alpha) and laboratory reagents (immunological) monitoring in accordance
with a protocol for anticyotkine therapy.
[ REDACTED ]
Publications of the results of the clinical trials will be done jointly. XXX has
the right to use the results of the trials as it wishes. The first publications
of the treatment of each condition will be in English and the first author will
be a representation of ABI. Later, if any Russian language reports are
published, the first authors will be members of the Institute.
If the Institute wishes to send a representative to a conference outside of
Russia to present the results of the clinical testing, ABI will pay expenses
(registration, travel and hotel) for one attendee per conference.
This agreement is made and signed in English and Russian languages and has the
same validity.
/s/Xxxxx Xxxxxxxxxx /s/Xxxxxx Xxxxxxxxx Xxxxxxxx
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on behalf of on behalf of
Advanced Biotherapy, Inc. the State Institute of Transplantation and
Artificial Organs of the Ministry of Health
of the Russian Federation
