Bemithyl: CONFERENCE CALL

STEMC stemc at interlog.com
Wed Sep 11 21:53:56 EST 1996


                         CONFERENCE CALL

(A transcript of a teleconference at the (June 25-29 1996) 31st Annual Meeting 
of the Canadian
Congress of Neurological Sciences in London, Ontario.  The teleconference was 
moderated by Dr.
Andre Alexandrov of University of Texas at Houston, and Dr. Mark Gawel of 
University of Toronto)

Q.   Did you conduct any research that would show that the long use of this 
preparation is safe?

A.   The preparation was clinically tested before being used in clinical 
practice here.  Our rules are that
the preparation must be lab tested first, then tested in a special testing 
clinic based on established test
parameters, and then is released for mass consumption. The material was tested 
in 1983 according to the
guidelines established by the Pharmacological Committee of the government and 
was approved for its use. 

The treatment procedure is three months long.  After that, in a year, there 
are two additional three-month
treatments.  The treatment is intermittent: continuously for the first three 
weeks, then - an intermittent
schedule: intake for five days, break for seven days and so on for the 
remainder of the three-month period. 
No  side effects were observed for the use of the drug during a three-month 
course and that could be
repeated two times during one year and this application is safe.

Q.   They do not recommend using it all the time on a continual basis at the 
moment, is that right?

A.   Yes. 

Q.   You are still using it in treatment for patients with muscular dystrophy 
on an ongoing basis?

A.   Yes.  It is used routinely in our  clinic.

Q.   Does it have anti-convulsant activities?  There was some suggestion from 
the literature that it
might have.

A.   Regarding anti-convulsants - the application of the drug would be much 
broader than it is
discussed right now and recently there was a third Russian conference on 
acto-protectors which are the
new kind of pharmacological agent,  acto' means  movement' and  protector' 
means' to protect', so   "to
protect the movement".  The preparation is used for treating patients with of 
liver disease and also to
correct asthenic syndrome.  It was initially developed as an adaptogen - to 
increase physical and mental
work capacity and to terminate condition of exhaustion.

Q.   There is a paper I just noticed here which suggests that it has 
anti-convulsant effect specifically.

A.   Oh.  Where is the paper?

Q.   The paper is .....

A.   Was it presented at the conference?

Q.   No.  It comes from Medline.

A.   Medline Search.

Q.   Yes.  Dr. Gawel says that it   is a paper on it changing the activities 
of an epileptogenic focus in
the raphe hippocampus and it suppressed the epileptogenic focus and penicillin 
induced epileptic foci.

A.   I found the article.  It was published in Experimental Clinical 
Pharmacology in 1995. The
substance used was Bemithyl?

Q.   Ya, right.

A.   The drug can be used in a variety of situations, and in this particular 
paper what they were using
is that this medication has anti-hypoxic effects and that could be the basis 
of its application in the epileptic
models.

Q.   It does not have an effect on carmodulan?

A.   Could you give more details on the carmodulan?

Q.   Carmodulan is one of the proteins which modifies the entry of calcium 
into the cell - calcium
channels.

A.   We just started to try Bemithyl in dystrophic myatonia, in the first 10 
patients and at the moment
it is too early to see if there is some particular affect due to that 
mechanism.  The effect was registered,
but it needs to be verified.

Q.   Using this routinely in muscular dystrophy?

A.   Yes.  It is being used routinely at our  clinic.

Q.   Any type of MD responds better?

A.   Primary myegenic dystrophy.

Q.   What is that?

A.   Our classification of dystrophies is different:  the first group is 
myegenic dystrophies where the
primary breaking is in the muscle and the second group is the neurogenic 
neuromyetrophy and the like. 
While it works for the second group, its effect is not as well articulated as 
for the first.

Q.   Within the primary myegenic group is there a particular subcategory, 
particularly responsive to
this substance?


A.   We feel that the Bemithyl is most effective during the stages of 
dystrophies particularly of those
which are slowly progressing and such type as   Erb's dystrophy.  For Erb's 
effectiveness is 20% higher,
than for Duchenne.

Q.   I just wondered whether you have used this also with patients with 
multiple sclerosis?

A.   They have not tried this drug in multiple sclerosis as yet.

Q.   Amyotrophic lateral sclerosis?

A.   Sorry.  OK.  We used it with a few patients and they cannot really say 
whether it was working or
not because mostly they saw patients with quite advanced stages of the 
disease.

Q.   What about use  in say Athletes  -  running?

A.   Well this preparation was initially developed to increase work capacity 
--  adaptation of a   cell --
and the data is no longer classified.  First the recipients of this drug were 
Russian astronauts before their
flights and then the second group who received this medication was military 
people who were working
in the high altitudes (anti-hypoxant action) and finally the drug was made 
available to athletes.  Recently,
there were papers published on that last subject.

Q.   So the effect on the cosmonauts was to increase physical  alertness or 
mental or both?

A.   Preparation affects their physical and mental capacity for work. Because 
the drug
influences mitochondrial processes so the effect is on both mental and 
physical capacities of a person.

Q.   What about on hypoxic conditions - does it also improve performance?

A.   There is work which was published about the use of this drug in high 
altitudes by the military and
Dr. Pustozerov is prepared to read something for you from it.

>From  Metabolic impairments, induced by high-altitude hypoxy'. The work was 
performed by the Central
Navy Clinical Hospital (Moscow) on the volunteers, aged 18-24-years-old who 
were tested with serial
blood tests to see metabolic activity and how Bemithyl could correct the 
metabolism and at the altitude
of 4,000 meters, it has been proved to improve the performance of these 
volunteers with various blood
tests. It helped stabilize a number of measured parameteres, improved exhaust 
of metabolites, etc.

Q.   Did you measure CPK values before and after treatment in the muscular 
dystrophy patients?

A.   In their study they notice that they measured the CPK levels (as well as 
of other ferments) before
and after and they found a decrease in value of the ferments and determined 
Bemithyl impact on cell
membranes.  This was shown in the study of the cell permeability, of 
erythrocyte  haemosysis.


Q.   What has haemolysis got to do with it?

A.   We did a test which is based on erythrocyte haemolysis which shows the 
state of the cell
membrane and how resistant it becomes to the various metabolites and in the  
study they used the blood
tests which were based on the haemolysis of erythrocytes and that is how they 
judged the improved
resistance of cell membrane.

Q.   You are talking about the muscular dystrophy patients?

A.   Yes.  This is an indirect test.

Q.   The old test that they used to use, looking at cell membrane of muscular 
dystrophy I remember
that back in 1978  there was a presentation on that.

A.   Yes.  That is the test.

Q.   Do they or do they not measure CPK?  That is the question.

A.   The levels of CPK and lactate hyonase actually decreased after the 
treatment. We have the data
right at hand.

Q.   Thank you Andre. Any age limit on the patients that you treat?
Early in life when they are just developing the weakness?

A.   The age of the patients was from 5 to 65 years.  So there was actually no 
age limit but please note
that the life expectancy in Russia is lower  right now than in the western 
countries and also in this
particular pathology too.

Q.   Would it be more valuable in children just beginning to develop the 
fairly rapidly progressing
weakness or in people who have had the disease longer?


A.   Bemithyl was more effective in patients with slow progression of the 
disease.

Q.   Is it used generally in Russia as part of a treatment protocol in these 
patients?

A.   Yes.

A.   Regarding CPK - there is some data here. They took a group of patients 
with muscular dystrophy
and measured them before treatment and it was 43.6 mean (units per liter). The 
standard deviation was
3.7. In this group of patients they divided them into two groups, one went for 
traditional treatment and
after the traditional treatment the mean was 36.2.  In the Bemithyl group 
after treatment the mean was
29.5.  The standard deviation is around 3. For the controls, the healthy 
volunteers, the level of CPK is 18.4
plus/minus 3.

Q.   That is not a very high level of CPK for people with muscular dystrophy.

A.   Indeed.

Q.   A nonlinear measurement.

A.   Yes.

Q.   OK.  This is the first data collected in Russia and I am intrigued with 
it.  The question is, should
we do a trial and is this encouraging enough to do a trial with the 
appropriate funding?

Q.   Were there any signs of benefit in any particular group of muscular 
dystrophy patients as
compared to the others?

A.   We went through that and we feel that Bemithyl is most effective with 
patients at the early stage
of the disease on those with a slow progression and in the type of dystrophies 
like myegenic dystrophy.

Q.   How did you get started on trying this preparation?

A.   Dr. Pustozerov started as what is here a Ph.D. student and when they were 
selecting a topic for
Ph.D. Thesis they were looking for the metabolic changes and different 
pathogenic mechanisms and
possible ways to treat myetonic dystrophies.  So they did a search of data 
available of agents that might
best fit into this area and they finally came across the new type of 
pharmacological agent being developed
in Russia which were the acto protectors and that is how they decided to make 
it a topic of the Ph.D. thesis
and then they decided to perform a trial.

Q.   Are all patients being treated with this drug in Russia and when do you 
suppose it might be
available here in North America?

A.   Dr. Pustozerov is working in St. Petersburg, Russia which is one of the 
major centers in the north
western part of the country, so many patients in this region receive treatment 
with Bemithyl, not only at
this clinic but also at various clinics at individual places and also they 
have very extensive correspondence
in which patients are requesting this treatment from elsewhere and they send 
the prescriptions outside of
their area.

The current situation is that first of all there is an historical perspective 
to this medication.  It was
developed by the efforts of three institutions, one in St. Petersburg, another 
is the Military Academy of
Medical Sciences in Moscow and the third is the actual manufacturer of the 
drug.  Everything was fine
during the Soviet days and they had very close cooperation but with the 
disintegration of the Soviet Union,
the St. Petersberg's clinic for example has to buy the medication using hard 
currency directly from the
manufacturer and at the moment the whole thing is hectic.

In Canada, STEMC Program of Toronto (416-250-0442, fax 416-250-1858, E-mail: 
stemc at interlog.com) recently 
acquired exclusive world wide rights for this preparation.

Does this answer your questions?

Q.   Yes, thank you.
What about dementia?  Is there any case of dementia?

A.   The drug has not been used in demented patients.  However, it was used in 
various asthenic
conditions.

Q.   So basically they used it also in, I understand, soldiers to improve 
performance and alertness and
physical performance.

A.   Particularly at high altitude situations.  There is a very interesting 
report here which Dr.
Pustozerov just mentioned about the experience in using Bemithyl in various 
psychiatric patients and the
interesting fact is that the positive effects of Bemithyl on the improved 
recovery, the speed of recovery and
the quality of improvement was found in patients who had psychiatric symptoms 
as the consequence of
various intoxications including alcohol and drugs, also infectious diseases 
and radiation and as a long-term
consequence of the head trauma and depression.  So it is quite a broad 
application.

Q.   You reckon things which cause delirium and general confusion and things 
like that .....

A.   Yes, I would rather suspect lesser acute situations but who knows.

Q.   OK.  Let's call that a day, Andre.  I think we have gone over most of the 
ground I wanted to cover.

A.   OK.

Q.   This is being recorded so we can get a transcript of this.

A.   Absolutely and I think that was a good try and we appreciate your effort 
and also the effort of Mr.
Bimman to support this presentation and I would like to ask for a few 
concluding words from the
presenter, Dr. Pustozerov of St. Petersburg, before we rap it up, OK?

Q.   Right.

A.   On behalf of Dr. Pustozerov, I would like to say that he was quite 
interested in this type of
presentation, this is very unusual for him indeed and the different source of 
questions expected and none
expected and this type of exchange of opinions may also be fruitful and just 
help to discover new
applications.

Q.   Thank you very much Andre, and I think that there were not that many 
questions and that many
people but I think it is an unusual format and people are a bit frightened by 
the telephone and as soon as
they see it they run away.

A.   Anyway we spent a quality hour here.

Q.   Right.

A.   Thank you to Mr. Bimman.
     
     Thank you's all around.
     Good-bye's all around.


                             THE END

For further information regarding Bemithyl, including
availablity, please contact STEMC:
Tel	: 416-250-0442(Toronto, Canada)
E-mail	: stemc at interlog.com
Web Site: "http://www.interlog.com/~stemc"




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