SEMAX®
Clinical Documentation

Clinical documentation in published form has started to enter the International Medical community as interest in this novel peptide grows. It is unfortunate that according to legal provisions of the Russian Federation, the records of the Federal Commission for Drug Registration and Application on preliminary clinical trials are prohibited from publication for a period of 10 years.

Published Articles

Rapid induction of neurotrophin mRNAs in rat glial cell cultures by SEMAX®, an adrenocorticotropic hormone analog.

Maria I. Shadrina, Oleg V. Dolotov, Igor A. Grivennikov, Petr A. Slominsky*, Ludmila A. Andreeva, Ludmila S. Inozemtseva, Svetlana A. Limborska, Nikolay F. Myasoedov
Institute of Molecular Genetics, Russian Academy of Sciences, Kurchatov square 2, 123182 Moscow, Russia.
Neuroscience Letters 308 (2001) 115±118
Received 16 February 2001; received in revised form 1 June 2001; accepted 7 June 2001

Abstract
The proliferation, differentiation and survival of neuronal and glial cells are affected by a number of neurotrophic factors, such as nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF) and others. In a previous study, we observed the effects of `SEMAX®' (Met-Glu-His-Phe-Pro-Gly-Pro), the physiologically active analogue of adrenocorticotropic hormone(4-10), on neuronal cell survival in vitro. We hypothesized that these effects may be mediated by the regulation of expression of some neurotrophic factors. To test this hypothesis we analyzed NGF and BDNF gene expression in glial cells obtained from the basal forebrain of newborn rats, following in vitro treatment with `SEMAX®'. We observed changes in mRNA levels for both the NGF and BDNF genes. The greatest increase in expression was found after 30 min of `SEMAX®' administration. At this time, BDNF mRNA level was increased eight-fold in comparison with control, and NGF mRNA level was increased five-fold. 2001 Elsevier Science Ireland Ltd. All rights reserved.
Keywords: Gene expression; Glial cells; Adrenocorticotropic hormone(4±10); `SEMAX®'; Nerve growth factor; Brain-derived neurotrophic factor; Neurotrophic factors.3

Novel synthetic analogue of ACTH 4-10 (SEMAX®) but not glycine prevents the enhanced nitric oxide generation in cerebral cortex of rats with incomplete global ischemia.

a c Valentina G. Bashkatova , Vladimir B. Koshelev , Olga E. Fadyukova ,
a b Alexandr A. Alexeev , Anatolii F. Vanin , Kirill S. Rayevsky , Igor P. Ashmarin ,
b ,* David M. Armstrong
a Institute of Pharmacology , Russian Academy of Medical Sciences , 8 Baltiyskaya Street , 125315 Moscow , Russia. b Lankenau Institute for Medical Research , Thomas Jefferson University ,Wynnewood , PA 19096,USA. c Department of Physiology , Lomonosov Moscow State University , Moscow , Russia Accepted 12 December 2000.
Brain Research 894 (2001) 145–149

Abstract
This work investigates whether nitric oxide production and lipid peroxidation contribute to the pathophysiology of ischemia and whether glycine and a novel Russian compound, Semax are neuroprotective via a mechanism involving the regulation nitric oxide (NO) and lipid peroxidation. In brief, nitric oxide and indices of lipid peroxidation were elevated following global ischemia. While glycine proved ineffective in reducing NO levels or ameliorating the neurological deficits following global ischemia, SEMAX® proved to be highly effective in abating the rise in nitric oxide and restoring neurologic functioning. Ó 2001 Elsevier Science B.V. All rights reserved.
Theme : Disorders of the nervous system
Topic : Ischemia
Keywords : Nitric oxide (NO); Electron paramagnetic resonance spectroscopy; Lipid peroxidation; SEMAX®; Global ischemia.

Mechanisms of Neuroprotective Effects of Semax® in the Acute Period of Ischemic Insult.

N.F.Myasoedov, V.I.Skvortsova, E.L.Nasonov, E..Yu Zhuravlyeva, I.A.Grivennikov, E.L.Arsenyeva, I.I.Sukhanov
The Chairs of Neurology and Neurosurgery Nos. 1 and 2 of the Russian State Medical University, Moscow Medical Academy "I. M. Secenova", Institute of Molecular Genetics of the Russian Academy of Sciences, Moscow .
Korsakov’s Journal of Neurology and Psychiatry 5. (1999)

Abstract
SEMAX® is the first domestic nootropic drug from the group of neuropeptides.
Experimental assays showed that in doses of 100-150 ug/kg body weight it had angioprotective, antihypoxic and neurotrophic effects. Complex neuro-physiological investigations demonstrated its high effectiveness in acute ischemic insult. This paper presents a clinical trial of the immunobiochemical mechanisms of the neuroprotective effects of SEMAX® in the acute period of an ischemic stroke. A retrospective comparison of clinical immunobiochemical analyses made it possible to obtain unbiased data, at the molecular level, on activating effects of SEMAX® on the anti-inflammatory chain of post-ischemic reactions in the brain, changes in the neuromediatory balance towards the prevalence of anti-inflammatory agents (interleukin-10, Transforming Growth Factor-ß1) over the factors maintaining the inflammatory process (interleukin-8, C-reactive protein).