Institute of Molecular Genetics, Russian Academy of Sciences (Moscow)

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Semax - an effective stimulator of the nervous system

    Developed by the Institute of Molecular Genetics, Russian Academy of Sciences (Moscow), in collaboration with the Biological Faculty of the Lomonosov Moscow State University. Produced as 0.1% sterile water solution nasal drops in 3 ml bottles with droppers; preserved with 0.1% nipagine.
     Semax is a heptapeptide, synthetic analogue of an ACTH(4-10) fragment of corticotropin, of the following structure: Met-Glu-His-Phe-Pro-Gly-Pro.
     Based on one of the endogenous neuropeptides regulating the functions of the central nervous system, Semax is a nonaddictive nootrop of prolonged action capable of stimulating memory and attention. It is characterized by wide spectrum of prolonged action, and the absence of hormonal activity and side effects. Therapeutic action of Semax after single application starts within 1 hour and lasts as long as 24 to 48 hours. Its effective doses (15-50 (g/kg) are roughly 1000 times smaller than those of widely known nootropil (pyracetame).
     Semax stimulates predominantly the functions of the anterior cerebrum. It positively affects the processes underlying perception, analysis of information, training and memory. Semax markedly improves the adaptation of the human organism to stress (hypoxia, cerebral ischemia, etc.). It facilitates recovery of mnestical functions after anesthesia. Semax supports high levels of attention, stimulates memory and facilitates accelerated recovery of intellectual and physical potential. Semax supports active attention and ability to work in conditions of nervous and psychic fatigue like strenuous operator activity. It also accelerates adaptation of the cardiovascular system to increased physical workload. Semax can be used for treatment of intellectual and mnestical disorders, of cerebral vascular diseases, for rehabilitation after craniocerebral traumas, treatment or prevention of post-anesthesia effects as well as for treatment of asthenoneurotic disorders of various geneses including ionizing radiation. Healthy people may take Semax to stimulate their memory and capacity for work, as well as improvement of the mood and neutralization of stress effects.
     Semax was tested on operators of the Perm Power Station, and mine rescue workers at the Coal Basin of the Moscow Region (Russia). The results suggest Semax to be potentially used among the following groups of people: operators of atomic and electric power stations, civil and military air traffic controllers, PC users, buisenessmen and officials during negotiations requiring high concentration of attention and memory, drivers and sportsmen.
     Semax has passed complete clinical trials in the Russian Federation. Its production in the form of nasal drops, use, and marketing have been authorised by the Russian Pharmacological Committee (Registration # 94/294/10 of November 10, 1994; License # 64/196/96 of March 28, 1996). In 1997 Semax was registered as a drug in Yugoslavia.

     In 1997 the State Pharmacology Committee has issued permission for clinical trials of Semax at optic nerve diseases. The trials were conducted by the Department of Therapeutic Ophthalmology of the Research Institute of Eye Diseases (Russian Academy of Medical Sciences). 74 patients of 16 to 84 years old (31 women and 43 men) suffering from optic nerve diseases of vascular, toxico-allergic and inflammation etiology (25.5, 16.3, and 24.5%, respectively) as well as from partial atrophy of optic nerve (33.7%) were observed. The trials have shown that:
     a) Semax included into the therapy complex of optic nerve diseases positively acted on the expression and rate of restorative processes facilitating improvement of visual functions.
     b) Semax can be applied intranasally in the form of instillation or administered by endonasal electrophoresis that enhances the action on pathology foci.
     c) Positive dynamics of the optic nerve state achieved through the introduction of Semax into the complex therapy provides for improvement of visual functions. Administered by instillation or endonasal electrophoresis, Semax led to increase in the acuity of vision (83.9 and 92.1% of cases, respectively), extension of the visual field borders (76.9 and 84.3%), and conductivity of the optic nerve and retina (67.7 and 76.3%). The data obtained were in line with a conclusion made in some experimental works that the mechanisms of neuron death depend not only on the absolute quantity of neurotoxic agents but to a great extent also on deficiency of neurotrophic influence.
     d) Administration of Semax, especially at the acute stage of optic nerve diseases efficiently protects the nervous tissue from damage after-effects, and reliably facilitates positive clinical dynamics assessed by increase of acuity of vision, vision field, electric sensitivity and conductivity of the optic nerve, and by improvement of color vision.
     e) Semax administered intranasally can be used as a nootrop for treatment of optic nerve diseases of vascular, toxico-allergic and inflammation etiology as well as for treatment of optic nerve partial atrophy.
     f) Recommended doses are 0.6-0.9 mg per day for instillations or 0.4-0.6 mg per day for electrophoretic administration. The results of 10-days period of treatment with Semax are more stable than those of 5-days period.
     g) All the patients well tolerated Semax, and no adverse effects of the preparation were observed.

     Consequently, the State Pharmacology Committee has issued permission N 4 of May 27, 1999, for the use of Semax in the form of 0.1% solution for treatment of optic nerve diseases. Moreover, after additional testing of Semax toxicity on sexually immature animals (acute, chronic, local irritation), the Committee admitted clinical trials of 0.1% Semax solution intranasally administered to children.