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Daval International Limited Gains Approval for Phase IIB Trial of AIMSPRO(R)
LONDON, November 26 /PRNewswire/ -- Daval International Limited, a UK private company, announces MHRA and IRB (Ethics Committee) approval of a London based Phase IIB trial of AIMSPRO(R), its hyperimmune caprine serum derivative.
This double-blind placebo-controlled cross-over study will seek to detect a beneficial effect on bladder function in patients with Secondary Progressive Multiple Sclerosis, following open-label observations over several years in a number of informed consent, "compassionate basis" patients.
AIMSPRO has an "export only" listing on the Australian Registry of Therapeutic Goods and a TGA Orphan Status Designation for the treatment of Krabbe's disease. An IND application is being lodged for a further MS trial in the United States.
AIMSPRO is a frozen medication, given as a 1ml sub-cutaneous injection every 4 days. It is believed to have a pronounced and sustained anti-inflammatory action with an associated, novel effect of lowering sodium channel triggering voltages in nerve fibres. MHRA applications for two further clinical trials are to be lodged within the next 3months.
Daval International Ltd. has recently been accepted as a member of the Association of the British Pharmaceutical Industry. "APBI"
Daval International Limited
Daval International Limited is a privately owned British pharmaceutical company, which, since 2001, has been developing an immunologically active human and veterinary medication derived from goat serum. Some 20.000 doses of Aimspro have been administered, mainly to human subjects with multiple sclerosis, with an excellent safety and tolerance profile.
Looks like things are on the up _________________ Keep smiling as who knows what good things might be around the corner and if the road snakes a bit keep going.
Joined: Jul 28, 2005 Posts: 1267 Location: Sydney, Australia
Posted: Tue Nov 27, 2007 2:02 am Post subject: Re: Aimspro gets Approval for Phase IIB Trial
Nemotoday wrote:
...AIMSPRO has an "export only" listing on the Australian Registry of Therapeutic Goods and a TGA Orphan Status Designation for the treatment of Krabbe's disease. ...
...Daval International Limited is a privately owned British pharmaceutical company...
I recently revisted davals Australian website, and found that it had gone. Dont know why. http://davalaustralia.com.au/
The trial for secondary progressive multiple sclerosis bladder function problems is to be conducted soon at the Whittington Hospital - Highgate - North London
By Professor James Malone-Lee
Interested?
Contact Dr Shozab Khan by e-mail
shozabkhan@gmail.com _________________ Keep smiling as who knows what good things might be around the corner and if the road snakes a bit keep going.
"Aimspro has been characterised biochemically and its mode of action has been determined.
it is composed of a set of peptide that act to stimulate the releases 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 peptide 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 carries 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 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.
In the case of Aimspro, a solution containing totally dead HIV viruses is injected into goats (the best mammal for this job) that have to be disease-free individuals (free of BSE, scrapie, etc.).
The HIV viruses are killed by two different methods and the solution is tested to make sure no live virus is present.
This disease-free requirement ensures no transmission of any disease from goat to human, only antibodies.
The goats are not harmed in any way; they merely provide small regular amounts of blood then go back to pasture.
The antibodies are officially described as "polyclonal antibodies". They are not chemical drugs; they are classified as "biopharmaceuticals".
Medical authorities have stated that antibiotics (derived from fungi) are near to the end of their useful lives due to their misuse and resistance build-up within bacteria. Although Aimspro does not work on bacteria there are many conditions that are caused by malfunctioning auto-immune systems.
It is thought that these polyclonal antibodies, which have anti-inflammatory properties in such diseases, will become a major force as antibiotics become useless in the not-too-distant-future.
Side effects may occur:
Irritation at injection site.
N.B.
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.
www.davalaustralia@westnet.com.aus (This link does not work) _________________ Keep smiling as who knows what good things might be around the corner and if the road snakes a bit keep going.
Posted: Sat Mar 08, 2008 10:01 pm Post subject: AIMSPRO
Dear members my name is seeva from SYDNEY AUSTRALIA is any member knows when this AIRSPRO IN AUSTRALIA. buying privatel will cost tomuch.
infusion every four days cost $1500.oo each time.
regards
seeva :?:
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