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 INNOVATIVE VISION PRODUCTS, INC.
Delaware Office - Moscow Office:
3511 Silverside Road, Ivanovskaya 20,
County of New Castle, Moscow 127434
Delaware USA 19810 Russia
Re: N-Acetylcarnosine Statement of Fact
February 3rd 2004
To Whom It May Concern, For the record I wish to confirm that I am Mark Babizhayev PhD, MA, and that I, along with my team of fellow research scientists, made the discovery and carried out all of the now published, research over the last eleven years for the application of N-Acetylcarnosine to address senile cataracts and related ocular disorders. I also wish to state that my company, Innovative Vision Products (IVP), is the holder of the worldwide patents for the use of N-Acetylcarnosine to address senile cataracts. In addition to our 1993 European Union patent application, we have filed patent applications in the United States and additional countries around the globe. The application of NAC for the treatment of cataracts has been protected by the PCT patents by our group."[Ed.- They are as follows: Babizhayev MA, Bozzo Costa E. Composizioni farmaceutiche contenenti N-acetilcarnosina per il trattamento della cataratta. Italian Patent A61K gruppo37/00 20122 MI, Priority 15.10.1993 and Babizhayev MA, Bozzo Costa, E. Pharmaceutical compositions containing N-acetylcarnosine for the treatment of cataract. Patent PCT/EP 94/03340 SCB 238 PCT, 10.10.1994].
Technical Statement
Firstly I wish to emphasize a very important point and that is that there are serious potential risks to ocular health with the long term application of any preparation used in the eye and therefore usage should always be carefully considered and monitored by patients and their physicians. As stated repeatedly in my publications there is a very fragile and highly specific balance of purity for this formulation that must be maintained to ensure the safe and effective use of N-Acetylcarnosine eye drops. Therefore, it must be clearly understood that it is only the formula made to this specific purity and methodology, the patented formula, that has been tested and proven in animal and in human clinical trials to be efficacious and most importantly, safe in long-term use.
Innovative Vision Products (IVP) is the patent holder and oversees the manufacture of the only clinically proven N-Acetylcarnosine formula such as supplied in Nu-Eyes ™. For public safety I established IVP to ensure that the highest qualities of standards are maintained for formula production control in a cGMP facility.
Warning
Unfortunately there are a
few immoral companies who are in patent violation, attempting to capitalize on
this discovery, which are illicitly manufacturing and selling N-Acetylcarnosine
for senile cataracts without the proprietary benefit of the specific level of
purity and methodology that was established in clinical trials required to ensure
efficacy and safety for eye use. A number of these companies are actually referencing
my research, to promote their sub-standard product, thereby damaging my reputation. Therefore as the publisher of much research on this subject, I feel a responsibility to inform consumers of the fraudulent and dangerous products being promoted to the public.
Some manufacturers are claiming that simple L-carnosine when applied topically to the eye without protection to enzymatic hydrolysis, can be delivered by eye drop direct into the aqueous humor or in the lens but this has not been demonstrated clinically by verified trials. There are problems with this claim. On the surface of the eye there naturally exist enzymes called carnosinase or aminopeptidases which break down any spare carnosine topically applied to the eye which will immediately start to breakdown any straight L-carnosine put into the eye into the two amino acid moieties that make up the di-peptide L-carnosine. These moieties include histidine. The continual release of L-histidine can release histamine in the eye via the histidine decarboxylase enzymatic activity and this could cause a damage to the eye tissue structures and induce inflammation or cascade of allergic reactions that is of great concern to professionals and our years of research on the subject at the Helmholtz Eye Institute in Moscow validates my view. When pure carnosine is converted to histamine during its metabolic breakdown, in no way it can affect cataracts, but instead can propagate cataract progression as histamine is acting as an active pro-oxidant in the presence of transition metal ions in biological tissues and fluids.
In addition some are attempting to make their products more attractive with
the addition of vitamins such as vitamin A and E. These vitamins, while by themselves
may be beneficial to the eye, have branched hydrocarbon skeletons that inhibit
the activity of N-Acetylcarnosine, particularly in the critical cornea and conjunctiva
of the eye. More importantly combinations of vitamins and N-Acetylcarnosine
have not been clinically researched for either efficacy or safety leaving the
possibility for damage of the eye surface with long-term use, as was shown
with L-Carnosine and vitamins in our experimental trials. Therefore as the publisher
of much research on this subject I feel a responsibility to inform consumers
of the fraudulent and dangerous products being promoted to the public.
 The good news is that there is a very simple way to determine if one is purchasing the safe, patented product formula. The following statement is provided on the eye-drop box labels by our approved private label distributors,
"N-Acetylcarnosine
Patented by Innovative Vision Products"
Why is it unique? - click
here! |
Nu-Eyes ™ provided
by BioNational Pharmaceuticals is one
such distributor.
Finding this phrase on the box ensures that you have the exact same formula
and purity, of eye drop, that was proven to be safe in our clinical trials.
To conclude, for public safety we shall be vigorously defending our patents and issuing injunctions against distributors of non-approved N-Acetylcarnosine anti-cataract eye-drops, furthermore we shall be seeking damages where appropriate. Cordially,
Mark
Babizhayev
Mark Babizhayev MA, PhD
More
about Dr. Mark Babizhayev
- click here!
NAC
compared to L-carnosine
We
may logically ask the question; why have NAC eye-drops been shown
to have this action upon cataract, and yet L-carnosine (which is its
sister di-peptide) appears to have little benefit? Dr. Mark Babizhayev,
(Click for Babizhayev Interview) one of the principal Russian researchers
behind the clinical trials with NAC eye-drops gave us this reply to
that very same question. |
 "I
believe that the application of simple L-carnosine for the treatment
of human cataracts is misleading. This is because L-carnosine, by
itself, readily becomes a substrate for the activity of natural peptidases
(i.e. carnosinase) in the aqueous humour to the degree that there
is virtually no sign of L-carnosine in the aqueous humour within 15
minutes after instillation.
Furthermore,
I consider that L-carnosine, in the form of eye-drops, may be harmful
to the eyes because it gradually releases histamine, which, located
as it would be in the presence of the eye-lens, is a very toxic agent.
NAC eye-drops however
are resistant to hydrolysis with natural carnosinase. Therefore, our
patented NAC is the only currently known agent which reverses and
prevents
human cataracts." Mark
Babizhayev MA, PhD |
In
conjunction with Dr. Hipkiss and Dr. Kyriazis information,
we can conclude that while some of the benefits of oral L-carnosine
may derive after carnosinase breaks down into histamine that in the
form of eye-drops, simple L-carnosine must be avoided.
It is also interesting to note that a study by Dr. Boldyrev et al,
also concluded that even the oral use of NAC was far less likely to
be broken down by carnosinase than simple L-carnosine.
Dr.
Mark Babizhayev also makes it quite clear that "ordinary"
L-Carnosine will not be of much use in the treatment of senile-cataract.
This is because there are many synthesized "carnosines"
and their biological and medicinal activity strongly varies and depends
on the mode of their obtention. Ed.
N-acetylcarnosine
Eye Drop Information Page - Click Here |
|
| For
example, if carnosine is extracted from meat muscle substances, the
biological and anti-oxidant activity is very low. This is presumably
due to the contamination of the "pure" carnosine substance
by heavy metal salts and proteins and other related impurities. It is
very difficult to purify carnosine chromatographically, as the compound
chelates divalent metal ions very heavily and the biological and anti-oxidant
activities can not be regenerated during the purification procedures.
In
conclusion there were many forms of carnosine, which were
abandoned, in the Russian studies because of their lack of anti-cataract
and anti-oxidant ability in the human eye,. However, Innovative
Vision Products (IVP), in conjunction with their Japanese partner
and manufacturer, have developed a synthesized pure NAC which has
biological activity and has been well controlled and proven in human
lens studies. This is the formula that has been used in the clinical
trials.
IVP holds the proprietary knowledge to the correct and efficient production
of high-purity NAC. If the label does not state that it is patented
by Innovative Vision Products (IVP), then the source of the raw material
is NOT the one that the clinical trials were conducted with. "Unknown"
sources of carnosine eye-drops should be avoided, as the material
could be ineffective, and possibly even dangerous to the human eye.
"Cataract
is a widespread age-related affliction and NAC eye-drops appear to
be a highly efficacious and safe treatment for cataract. As such,
I suspect that this supplement is going to become one of the most
important new discoveries, and will have a major impact on the way
that cataract is controlled." -
Mark
Babizhayev MA, PhD
References:
1. Boldyrev AA,
Dupin AM, Bunin Aya, Babizhayev MA, Severin SE "The antioxidative
properties of carnosine, a natural histidine containing di-peptide."
Biochem. Inrern., 1987, 15/6, 1105-1113.
2. Babizhayev MA et al "N-Acetylcarnosine, a natural histidine-containing
di-peptide, as a potent ophthalmic drug in treatment of human cataracts."
Peptides (USA) 2001, 22(6): 979-994.
3. Babizhayev MA, Yermakova VN, Deyev Al, Seguin M-C "Imidazole-containing
peptiomimetic NACA as a potent drug for the medicinal treatment of
age-related cataract in humans." J. Anti-Aging Medicine 2000,
2, 43-62.
4. Babizhayev MA, Yermakova VN, Semiletov yu A, Deyev Al "The
natural histidine-containing di-peptide N-acetylcarnosine as an antioxidant
for ophthalmic use." Biochemistry (Moscow), 2000, 65, 588-598.
5. Babizhayev MA, Yermakova VN, Sakina NL, Evstigneeva RP, Rozhkova
EA, Zheltukhina GA "N-Acetycarnosine is a prodrug of L-carnosine
in ophthalmic application as antioxidant." Clin. Chim. Acta.,
1996, 254, 1-21.
6. Babizhayev MA, Bozzo Costa E "Composizioni farmaceutiche contenenti
N-acetilcarnosina per il trattamento della cataratta." A61K gruppo
37/00 cap 20122 MI 15.10.1993. Italian patent.
7. Babizhayev MA, Bozzo Costa E "Pharmaceutical compositions
containing N-Acetylcarnosine for the treatment of cataract."
European Patent PCT/EP 94/03340 10.10.1994 Ref. SCB 238 PCT.
8. Babizhayev MA, Seguin M-C, Gueyene J, Evstigneeva RP, Ageyeva EA,
Zheltukhina GA "L-carnosine and carcinine act as natural antioxidants
with hydroxyl-radical-scavenging and lipid peroxidase activities."
Biochem J. 304, 509-516.
9. Babizhayev MA, "Antioxidant activity of L-carnosine, a natural
histidine-containing di-peptide in crystalline lens." Biochem.
Biophys. Acta., 1989, 1004, 363-371.
10. Babizhayev MA, Deyev Al "Lens opacity induced by lipid peroxidation
products as a model of cataract associated with retinal disease."
Biochim. Biophys. Acta., 1989, 1004, 124-133.
11. Babizhayev MA, Deyev Al "Free radical oxidation of lipid
and thiol groups in genesis of cataract." Biophysics (biofizika),
1986, 31, 119-125, Pergamon Journals Ltd.
12. Kantha S, Wada S, Tanaka H, Takeushi M, Watabe S, Ochi H (1966),
Biochem. Biophys. Res. Commun. 223, 278-292.
13. Babizhayev MA, Deyev Al, Linberg LF "Lipid peroxidation as
a possible cause of cataract." Mech. Ageing Dev. 1988, 44, 69-89.
14. Boldyrev AA, "Problems and perspectives in studying the biological
role of carnosine" International Center for Biotechnology, Department
of Biochemistry, Lomonosov, Moscow State University.
15. Hipkiss A, (1998) Int. J. Biochem. Mol. Biol., 30, 863-868.
16. Boldyrev AA, Dupin A, Bunin A, Babizhayev MA, Severin SE (1987),
Biochem. Int., 15, 1107-1113.
17. Wang AM, Ma C, Xie H, F Shen "Medical application of carnosine
" Department of Biochemistry and Neurobiology, Harbin Medical
University, China.
18. World Health Organisation, Ageing and Health, Website: http://www.who.int/ageing/scope.htm
DISCLAIMER: ALL INFORMATION IS EDUCATIONAL AND DOES NOT, AND SHOULD
NOT, REPLACE THE ADVICE OF YOUR PHYSICIAN.
Last Updated: Tuesday, July 20, 2004 |
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