Aimspro®
The drug has been characterised biochemically and its mode of action has been determined.
It is composed of a set of peptides that act to stimulate the release and regulation
of a molecular cascade that modulates the Hypothalamo-Pituitary-Adrenal (HPA) axis.
In addition, Aimspro has powerful anti-inflammatory properties as it contains cytokines
that induce a predominantly TH-2 anti-inflammatory profile in the patient. It has
become apparent that some of the peptides in Aimspro are regulated and bound by specific
carrier molecules that may regulate the action and release of their ligand and are
probably necessary for the appropriate regulation and pharmacokinetics of the molecular
machinery. The carrier molecules also function as a slow release mechanism, releasing
bioactive components over several days."
It is a highly specific product obtained by vaccinating a specially selected herd
of goats and then preparing the active component.
This is a powerful anti-inflammatory agent which is associated with the induction
of tissue repair factors some of which are known to enhance nerve conduction. Like
a few dramatic developments in the pharmaceutical world the creation of Aimspro was
an offshoot of a line of research looking for a treatment / cure for a specific human
affliction. Since World War 2 people have been increasingly protected against many
diseases by means of inoculations that involve the use of vaccines. Some that spring
to mind include polio (Salk), hepatitis, meningitis, cervical cancer, smallpox, tetanus,
rabies, influenza and many others. If one takes polio as an example, the Salk vaccine
is produced by injecting dead polio viruses into fertilized hen’s eggs and then extracting
the created antibodies produced by the embryo to counter this ‘invasion’. The antibodies
are then stored as a serum in vials before injection into humans.
The antibodies are officially described as “polyclonal antibodies”. They are not
chemical drugs; they are classified as “biopharmaceuticals”.
Side effects may occur
Irritation at injection site.
Currently
- Aimspro ® is available in the U.K. as a ‘special’ Drugs granted a ‘special’ licence
in the UK may be prescribed by a doctor, neurologist and dentist.
- Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis has been designated
to Aimspro® by the FDA. Drugs designated an ‘Orphan Status’ in the US require an
IND approval - ALS is the most common form of Motor Neuron Disease (MND), also known
as Lou Gehrig’s disease.
- Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis has been designated
to Aimspro® by the TGA. ALS is the most common form of Motor Neuron Disease (MND),
also known as Lou Gehrig’s disease.
- Orphan Status for the treatment of ‘Krabbes Disease’ has been designated to Aimspro®
by the TGA
- Aimspro® has category B status designated by the TGA
- A patent for 'The Treatment of HIV' has been added to the AIMSPRO IP portfolio, having
an effective date of 31st March 2009. The patent has been granted by the African
Intellectual Property Organisation (O.A.P.I. – Organisation Africaine de la Propriété
Intellectuelle) and it covers the African states of Benin, Burkina Faso, Cameroon,
Central African Republic, Chad, Republic of Congo, Cote d'Ivoire, Equatorial Guinea,
Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal and Togo. The grant
of this single patent is valid in all these countries.
Many drugs that have been licensed for a specific disease are also prescribed off
label, in other word used to treat another disease they have not been specifically
licensed for, it is not uncommon.
There are very important mandatory import formalities for biological products throughout
the world, though the fact that a hyper immune serum is derived from a low risk country
helps facilitate the necessary application process.
N.B.
It is important that any new and novel treatments such as; biological products, stem
cell therapy, interventions and so on, have a designated status from or have been
licensed by a recognised government drug regulatory agency. This ensures that the
general public is protected from unfounded and unproven claims that may be made.
If a drug or therapy has not been licensed or designated an approved status it would
be unethical and potentially dangerous for any recommendation for it’s use to be
made, a classic example is the stem cell therapy furore several years ago when many
hundreds of sufferers were encouraged to travel to other countries for a treatment
that may of been at best ineffective and at worst a useless yet expensive experience.
In some instances the clinics were found to be illegal.
Notes
Other Web Sites
Review Paper - www.sciencedirect.com/science
Daval International
regulatoryaffairs
sypharma.com
Therapeuticsdaily
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