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"
