The new Chinese and old Colonial, side by side in central Shanghai
I do not speak Chinese, but
fortunately Google does.
I was sent some interesting links to
some articles from China about Suramin, the potential autism therapy which many
autism parents are eagerly awaiting.
Prepare for a long wait, but hopefully less long in China.
My original post on Suramin for
autism can be found in the link below:-
Suramin, the Purinome and Autism
I have never had a banner appear on my
computer trying to sell me a Rolls Royce until today. This is more proof, if I needed it, of how
much China has changed since my first visit there as a teenager. Back then there were a lot of bicycles; I still
remember many were Flying Pigeon brand – not a name you forget. I just looked
them up and since 1950, more than
500 million Flying Pigeon bicycles have been made - that is a lot bicycles.
I even
went to see a factory still producing steam locomotives in Datong in the 1980s.
They gave you a personal certificate of your visit, which I still have somewhere.
Last
year I was again in China and travelled on their ultra-modern high speed trains. These run on purpose-built tracks, often
running to totally new vast railway stations.
The network is massive with 36,000 km (22,000 miles) in total length and trains
running at speeds up to 220 mph / 350 km/h.
The ride is perfectly smooth and the tickets are not so expensive. The old train lines I used many years ago
still exist and you can still take the “hard sleeper” to travel long distances
overnight for little money, but not quite as cheap as it once was.
Things move fast in China, hopefully so will Suramin
Suramin is an approved drug, but it is almost impossible to get hold of, unless you are in a limited number of African countries affected by African Sleeping Sickness and River Blindness. Suramin is made by the German giant Bayer and the brand name (below) is not very original.
I think the
clever idea is the intranasal version now being developed in the US.
But why not
just put this old drug from 1916 in a metered pump dispenser, in the same way
the Alzheimer’s researchers put insulin in a nasal spray? In autism, Vasopressin and Oxytocin are just popped
into nasal sprays. A few years in this
blog I mentioned Dr Jay Goldstein who was treating people with TRH intranasally
(he wrote a great book called Tuning the Brain – I actually bought it).
Tuning the brain
eventually got Jay Goldstein into trouble. Though long “retired”, he has just
published another book on ME/CFS.
Goldstein also used Ketamine eye drops and nasal spray.
I guess if
he would have been among the first put this old Suramin drug in a nasal spray
and see what happens. It quite possibly would help ME/CFS, as suggested by Dr
Naviaux himself.
We saw in a post in 2014 that
Professor Rita Levi-Montalcini had
the clever idea of using home-made NGF eye drops to stave off decline in old
age. She was the first one to discover
the existence of Nerve Growth factor (NGF). She became the first Nobel laureate
to reach the age of 100. The NGF eye drops did not
do her any harm.
Your eyes are part of the Central Nervous System (CNS) and so an ideal entry point to target the brain. For nasal sprays the route to the CNS is via the trigeminal nerves and not much actually gets through (see below). Due to the blood brain barrier many drugs taken orally cannot reach the brain.
Nose-to-Brain Delivery
The route of transfer of compounds through the nasal respiratory epithelium to the brain is via the trigeminal nerves
A key advantage of the nose-to-brain route is the
possibility of reducing plasma exposure, as has been demonstrated thus
eliminating peripheral side effects.
Simply
dissolving the drug molecule in an aqueous phase has been used to administer
molecules via the nose-to-brain route. The vast majority of clinical studies,
which report pharmacological effects, have involved a solution of the drug in
aqueous media delivered using a nasal delivery device
Oxytocin has also been delivered to the brain via
the nasal route using a solution with a Cmax of 0.003% of a 10 μg dose being found
in the brain. A solution of the human immunodeficiency virus replication
inhibitor DB213 delivered the drug to the rat brain with a Cmax that was estimated at no more than 0.007% of the administered dose.
The addition of functional excipients to these
solution formulations improves brain delivery via the nasal route.
It may
well be that Rita and Jay got it right by choosing eye drops over a nasal
spray. Suramin eye drops? Not as crazy as it may sound. Perhaps in China?
Back to
China
Hand,
foot, and mouth disease is common in children under five years old, but anyone
can get it.
The
illness is usually not serious, but it is very contagious. It spreads
quickly at schools and day care centres.
Hand, foot, and mouth
disease is caused by viruses that belong to the Enterovirus family.
Common causes of hand,
foot, and mouth disease are:
- Coxsackievirus A16 is typically the most common cause of hand, foot, and
mouth disease in the United States. Other coxsackieviruses can also cause
the illness.
- Coxsackievirus A6 can also cause HFMD and the symptoms may be more severe.
- Enterovirus 71 (EV-A71) has been associated with cases and outbreaks in East and Southeast Asia. Although very rare, EV-A71 has been associated with more severe diseases, such as encephalitis.
Suramin inhibits EV71 infection
Highlights
·
Suramin
inhibits the proliferation of EV71 virus.
·
Suramin
directly blocks the attachment of EV71 virion to host cell.
·
Suramin can be used as a potential
clinical therapeutic against EV71 infection.
Abstract
Enterovirus-71 (EV71) is one of the major causative reagents
for hand-foot-and-mouth disease. In particular, EV71 causes severe central
nervous system infections and leads to numerous dead cases. Although several
inactivated whole-virus vaccines have entered in clinical trials, no antiviral
agent has been provided for clinical therapy. In the present work, we screened
our compound library and identified that suramin, which has been clinically
used to treat variable diseases, could inhibit EV71 proliferation with an IC50
value of 40 μM. We further revealed that suramin could block the attachment of
EV71 to host cells to regulate the early stage of EV71 infection, as well as
affected other steps of EV71 life cycle. Our results are helpful to understand the mechanism for
EV71 life cycle and provide a potential for the usage of an approved drug,
suramin, as the antiviral against EV71 infection.
The approved pediatric drug suramin identified as a
clinical candidate for the treatment of EV71 infection - Suramin inhibits EV71
infection in vitro and in vivo
Kangzhi Pharmaceutical has the rights to develop Suramin for hand foot and mouth disease in China and beyond.
Kangzhi Pharmaceutical has developed a new indication for "Suramin Sodium" and is committed to the development of drugs for hand, foot and mouth disease
Currently,
there are no specific antiviral drugs for enteroviruses in the world, and
support and symptomatic treatment are the main ones. Clinically, there is an urgent
need to develop specialized drugs to treat patients with hand, foot and mouth
disease who have been infected. Now that Kangzhi Pharmaceutical's suramin sodium for
injection has been approved for clinical trials, it is undoubtedly a gospel for
children with hand-foot-mouth disease and is expected to break the dilemma of
treatment of hand-foot-mouth disease.
Kangzhi
Pharmaceutical has been focusing on children's health for a long time. Under
the guidance of "Children's Health Strategy" and "Excellent
Strategy", the company insists on investing about 5% of its annual sales
in research and development. In 2013, the company took the lead in
establishing a post-doctoral scientific research station with children's drug
research and development as the main direction in China, and was recognized as
"Hainan Children's Drug Preparation Engineering Technology Research
Center" in 2016. In
order to solve the problem of no medicine for hand, foot and mouth disease,
Kangzhi Pharmaceutical has invested heavily in the research and development of
suramin sodium for injection.
It is understood that hand, foot and
mouth disease is an infectious disease that is generally susceptible to infants
and children under 5 years old. It continues to be prevalent at a fixed period
every year. There is no specific medicine for targeted treatment. According
to the statistics of the my country Center for Disease Control, the number of cases of hand,
foot and mouth disease in China in 2018 was 2,533,310.
Obviously, if Kangzhi
Pharmaceutical's new hand, foot and mouth disease drug can be successfully
listed, it will become a major "cash cow" product of the company. By
then, both performance and stock price will be effectively
boosted. However, since this product was exposed by Kangzhi
Pharmaceutical, the outside world only knows that this product will be
"the world's first new medicine for the treatment of hand, foot and mouth
disease", but its final market is still far away.
"The
company has obtained the approval for the clinical trial of the drug, and the
product has successfully completed the phase I clinical trial and will start
the phase II clinical trial. If the clinical trial is successful and the
marketing authorization is obtained, suramin sodium will become the world's
first treatment for hand, foot and mouth. New medicine for
disease.” In the 2019 financial report, Kangzhi Pharmaceutical introduced the
latest development of suramin sodium.
As early as 2015, after Kangzhi
Pharmaceuticals spent 18 million yuan to buy the patented technology of
"Institutions and Methods for Treating Viral Diseases" of the
Shanghai Pasteur Institute of the Chinese Academy of Sciences, and planned to
invest 50 million yuan in suramin Subsequent research and development of
sodium.
In
2018, after the application for the clinical trial of suramin sodium was
submitted, it was quickly reviewed and approved according to the special review
route. At that time, Hong Liping,
vice chairman and vice president of Kangzhi Pharmaceuticals, said in an
interview: "Suramin sodium for injection is approved for clinical trials,
which is an important achievement of Kangzhi Pharmaceuticals in the development
of new drugs. The company deeply feels the responsibility. With the help of the
current national policy to encourage the spring breeze of clinically urgently
needed therapeutic drugs, we will actively promote the development of clinical
trials of the drug and promote the market of new drugs as soon as possible to
help children with hand, foot and mouth disease get rid of the disease as soon
as possible.
According to the company's secretary
of the board of directors on the Shenzhen Stock Exchange, the clinical trial of
suramin sodium is divided into 3 phases, and only phase 1 has been completed.
The time of the clinical trial is uncertain.
It is reported that the new indication of suramin sodium for the
treatment of hand, foot and mouth disease developed by Kangzhi Pharmaceutical has previously
applied for an international invention patent through the PCT, and has
successively obtained invention patent authorization in China, Japan, Singapore
and the United States. The new Indonesian patent authorization will
help to further leverage the advantages of independent intellectual property
rights, promote the research of hand-foot-mouth disease treatment drugs,
benefit the world's hand-foot-mouth disease patients, and enhance the core
competitiveness of Kangzhi Pharmaceutical.
Conclusion
It
looks like there will eventually be at least 3 pharmaceutical companies selling Suramin.
• Bayer
(Germany)
• Kangzhi
Pharmaceutical (China)
• Paxmedica (USA), or really which ever Big Pharma they sell out to
This
is all good news for autism and hand foot and mouth disease.
People
do not like injections, nor side effects caused by your drug needlessly going
everywhere in your body.
The
nasal spray, or eye drops, look a good idea for autism and ME/CFS.
Hopefully
the Chinese will move fast, like their trains, and bring their Suramin to the
market.
In 2008 Arnold Schwarzenegger signed a bill to bring high speed rail to California. The total system length would have been approximately 800 miles (1,300 km). Where are we 12 years later?
The
British are no better with their high-speed rail, but it is a very densely
populated country. China's new rail lines were not built where the old lines ran. Spain actually has really good high-speed trains, that are
not so expensive and a great way to get around the country.
Where
are those autism drugs, "fast-tracked" for approval by the FDA? In the same place
as Arnie’s model train set (going nowhere fast).