NovochizolTM intellectual property is fully owned by Novochizol SA, a Swiss Public Limited Company having
its registered office at Route de l’Ile-au-Bois 1A, 1870 Monthey, Switzerland.
Worldwide patent applications have been filed on February 11, 2020.
NovochizolTM is a registered trademark as of December 18, 2019.
Pavel Shafranovskiy, PhD MBA
Business Director - Chemical Physics
• Chemical physics, Business administration.
• Active in healthcare business for over 30 years: international medical distribution, multinational clinical trials, successful start-up projects, founder of Children’s hearts charity foundation.
Vladislav Fomenko, PhD
CSO - Chemistry
• Medical chemistry, Drug formulation, oligonucleotide chemistry, synthesis of optically pure alpha-amino acids, phytochemistry, nanomaterials, phytochemical analyses of Siberian flora, drug discovery.
Business development - Material Sciences
• University Diploma in physics.
• Research interests: development of reagents for molecular biology, medicine and industrial chemistry.
• 28 year experience setting up and running various SMEs (life sciences, oil, grains).
Yvan (Vanya) Loroch, Ph D
CEO - Biology
•Molecular Biology and genetics, oncology, biotechnology.
• 30 year experience in life science communication and education aimed at all stakeholders in pharma, biotech and medtech.
What can you say about the safety of NovochizolTM ?
We believe NovochizolTM is as safe as its starting material, chitosan (GRAS).
NovochizolTM nanoparticles have been tested extensively in a preclinical setting in human cell lines. Including mice (intramuscular, intracardial, intestinal injections, brain – dural graft substitutes, ocular applications). As well as pigs (intra-pulmonary aerosols, intracardial and renal artery injections), dogs (brain – dural graft sustitutes). Additionally, it has been tested on chicks (ocular applications) and rabbits (ocular applications) too.
No clinical studies have yet been conducted as part of any drug development program.
What chitosan do you use as starting material?
How do you know that chitosan’s biological activities are preserved in NovochizolTM ?
We always compare the biological activity with the original chitosan. For example, the original chitosan enhances the denervating effect of botulinum toxin. However, since we can measure it quantitatively in Volts, we see how much the effect is enhanced with Novochizol, compared to chitosan. We can say the same about the transport function of the Novochizol compared to chitosan. Microscopically, we see a noticeable difference with chitosan. Thus, the biological effect is measured either as a percentage of the increase in denervating ability. Or, if chitosan does not show visible activity, then simply as an effect. We see a much more pronounced effect when applied to the cornea. Also when penetrating into the endothelium of the intestine, or when penetrating into leukocytes. Some effects we evaluated subjectively. Thus, when assessing effects on sunburns, half of the affected back was treated with chitosan. The other half was treated with Novochizol. Visually, the next day, the redness was substantially decreased in the latter. Subjectively, the pain was significantly reduced or even absent when Novochizol was used.
What can you say about the genotoxicity of NovochizolTM ?
We have completed a full cycle of preclinical studies for a combined preparation with botulinum toxin for injectable use. No genotoxicity was observed. There are minor problems with apyrogenicity, which are solved by special methods that exclude the ingress of pyrogens in raw materials. Furthermore, in acute and chronic toxicity tests, the NOVOCHIZOL- botulinum formulation was less toxic than the original botulinum toxin.
Are there evidences that supports NovochizolTM tissue adhesion?
Firstly, we have microscopic data on the binding on the cornea and the endothelium of the intestine with penetration into the cells.
Secondly, we have data from immunohistochemical studies on the penetration of botulinum toxin into muscle cells. The cells that are not directly exposed to the botulinum toxin-Novochizol nanoparticles temain toxin-free. Also, the denervating effect is only observed in muscles wehere the injection was made. No systemic effects can be observed, event at very high doses of toxin, up to 75 LD50 (mice) for 1 rat.
Finally, we have data on injections into the renal artery of highly active pharmaceutical ingredients and we consistently observe that the biological responses are strictly local, confined to the kidneys.
What evidence supports NovochizolTM antimicrobial effects?
Novochizol has bacteriostatic properties and is a poor medium for the growth of bacteria. Moulds (mukor) from the environment can hardly grow in Novochizol solutions. Thus, we are now conducting tests with bacterial cultures to assess antibacterial poperties. We performed a number of surgical operations to implant products impregnated with Novochizol. The animals appeared healthy throughout the long-term assessments of biocompatibility of implants over periods of up to 6 months. There were noinfections, suppurations or abscesses.
What is the scale of your manufacturing process?
450 grams per batch. It is easy to scale-up the process since there are no large thermal effects. The reactions do not proceed too quickly and there is ample time for adequate mixing.