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Second
interview with Mark Babizhayev, PH.D.
The correct manufacturing of
pharmaceutical agents
At the 1st Paris Anti-Aging Conference,
February, 2003, Dr. Babizhayev talked about the Russian breakthrough of
N-acetylcarnosine for the treatment of senile cataract. IAS took the opportunity
to interview Dr. Babizhayev further, about the precise role of N-acetylcarnosine
and a number of important factors were raised in the discussion.
Phil: “Dr. Babizhayev, thank you very much for
joining me here today, to discuss your important breakthrough of an eye-drop to
treat, and possibly to prevent senile cataract. I know by the response that the
readers of the IAS Anti-Aging Bulletin, enjoyed our previous discussion.”
Dr. Babizhayev: “It’s a pleasure to be in Paris
with you Phil.”
Phil: “As you know, we have already covered a lot
in our previous article and interview, about the development of
N-acetylcarnosine and its role in combating the common aging-disease of senile
cataract. We were made very aware in those, that there are significant
differences between L-carnosine and n-acetylcarnosine, and we warned everyone
then that they shouldn’t use L-carnosine for eye-use. But tell us, are there
any differences in N-acetylcarnosine itself?”
Dr. Babizhayev: We have developed a very precise
product of N-acetylcarnosine, both from the point of view of purification, and
its content of transition metal ions traces. This is because, rather uniquely,
only certain types and levels of impurities enable the maintenance of the
peculiar antioxidant activities of the released molecule, including those
scavenging the hydroxyl radical, singlet oxygen, lipid peroxidase-like and
ferroxidase-like activities. This very particular active product is responsible
for the anti-cataract efficacy, and for the protection of the lens proteins from
the singlet oxygen-induced oxidation of the lens protein, specifically the
aminoacid tryptophan residues, which have been measured using chemiluminescenece
technique and L-Gly-Tryptophan peptide. Some details of this were published in
one of our papers. (reference 1 below).
Phil: “So, when you were experimenting with your
different N-acetylcarnosines, was there a difference in their efficacy, or side
effects?
Dr. Babizhayev: “Oh yes, sure! With either
too much or too little metals, side-effects were caused, or we saw less efficacy.
The manifested lipid hydroperoxides scavenging activities of the released
carnosine, and the ferroxidase activities of the final released product in the
eye are all very important.”
Phil: “Thus, I imagine, you must have decided
upon a specific N-acetylcarnosine with a narrow range of purity, that was, in
terms of its impurities, not-too-much, not-too-little. Is that form commonly
available?
Dr. Babizhayev: “No, that form is not commonly
available, and the information is kept proprietary. The specific
N-acetylcarnosine in question, is manufactured by our Japanese partner under a
cGMP specific know-how process. Therefore, this material is currently only
available from one source, which is Innovative Vision Products, the
patent holders.”
Phil: “So how can people tell if they are using
the correct material in their eye-drop?”
Dr. Babizhayev: “The packaging should clearly
state that the formula is approved and patented by Innovative Vision Products/
IVP.”
Phil: “Now we understand the importance of the
type of carnosine and its purity for eye-drops. Are there any problems in the
formula? By which I mean, what happens if you start to change the formula
by adding additional ingredients, etc.?”
Dr. Babizhayev: “Innovative Vision Products, Inc.
has conducted serious pharmacokinetic studies utilizing precise chromatographic
techniques of analysis, and using the final formulated patented Can-C product
and other various possible formulations. The ratio of carnosine/NAC
concentrations upon the topical application of Can-C to the eye, is equal to 9
in the aqueous humor. This means that virtually all N-acetylcarnosine is
converted to the more powerful antioxidant L-carnosine in the aqueous humor.
This can then enter the lens tissue and epithelial cells, and act as the
anti-cataract remedy.
N-acetylcarnosine is a delicate molecule. The
biotransformation of N-acetylcarnosine into L-carnosine in unsolicited external
topical formulations, can be promptly inhibited. Active L-carnosine can not be
detected in the aqueous humor after the topical installation of hydrophobic
vitamin-loaded remedies after 15 minutes, at any significant doses. It is not
apparent that when chemicals are mixed together, chemicals which, by themselves
may have efficacy, that the sum is greater than the single parts. These
chemicals interact with one another, and in the eye, these additional
interactions could cause side effects or lose the efficacy of the original
product.”
Phil: “As I understand it, now we know that the
amount of transformation of N-acetylcarnosine into L-carnosine, and the length
of life/ activity of that L-carnosine in the aqueous humor are all essential
elements in the efficacy of N-acetylcarnosine eye-drops. I therefore suspect
that you must be concerned about copy-cat products that claim your research, but
actually contain inferior N-acetylcarnosine and formulas that have little
value?”
Dr. Babizhayev: “Yes, I fear that such inferior
products will mar my entire research and maybe people will think that all
N-acetylcarnosine is the same, and that eventually it will block even the
correct product and formula from coming to market. However, myself and our
shareholders are addressing this issue, and in those countries where such
products are currently being used, our patents there will be in force later this
year and we shall pursue them.”
Phil: “I guess it’s actually part of that old
adage, when we say, the devil is in the detail.”
Dr. Babizhayev: “Indeed it is Phil.”
Phil: “I appreciate that it is still early days,
but do you feel, or do you have any scientific reasoning, if N-acetylcarnosine
will be useful in other eye-disorders?”
Dr. Babizhayev: “Yes, we believe that
N-acetylcarnosine will have a role for glaucoma, especially when combined with
some other substances that we are currently working on. In particular, we know
that N-acetylcarnosine is efficacious for its anti-glare effect and improvement
for color vision. So, for example, we envisage that this could lead to safer
driving, especially night driving.
Another interesting, recent development is the fact that
we have shown N-acetylcarnosine to prevent and reverse the acidosis in the
corneal stroma due to the actions of accumulated lactic acid. This means that
individuals can wear contact lenses, particularly soft contact lenses, which are
not gas permeable, for longer and with more comfort.”
Phil: “Have you enjoyed yourself here in Paris?
I mean, professionally of course! What kind of response are you getting to
your trials that show n-acetylcarnosine to be highly efficacious in the
prevention and treatment of senile cataract?”
Dr. Babizhayev: “Yes, the response wherever I go
is very favorable and I think that eventually the word about this breakthrough
is going to spread worldwide. We are close to some arrangements that would
probably mean the general media would know and report about this, when that
happens I expect much will change quickly.”
Phil: “I’m sure there will continue to be some
resistance to this breakthrough, after-all, it always takes some time to accept
new ideas, and especially for the mainstream media to start reporting on it. But
then, that’s why people read the IAS Anti-Aging Bulletin, to be ahead of the
crowd, and keep up-to-date on the cutting-edge.”
Dr. Babizhayev: “Yes, I believe it is a most
worthy enterprise.”
Phil: “Thank you for your time with us here today
and enjoy the rest of your stay in Paris.
Dr. Babizhayev: “Thank you, I will.”
References:
- Babizhayev MA, Lozovskaya EL,
Makareyeva EN, Lulkin YA, Sapezhinskii II, “Photoprotector
and antioxidant properties of histamine containing peptidomimetics in the
photooxidation of glycyltryptophan.” Biochemistry (Moscow), 1998
May;63(5):523-8.
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