PCCAR-09
for peripheral arterial disease
Target population:
Patients with peripheral arterial disease (PAD)
Peripheral Arterial Disease (PAD) is a condition in which narrowed arteries reduce blood flow to the leg
It may cause leg pain when walking (claudication) and other symptoms
Ankle-brachial index (ABI) test compares the blood pressure measured at the ankle and at the arm. ABI less than 0.9, which defines PAD, indicates narrowing or blockage of the arteries in the legs
PAD may affect 2.5-5% of the World General Population, its prevalence strongly increasing with age
Peripheral Arterial Disease (PAD) – a very serious medical condition
PAD is a deadly disease. Ankle Brachial Index Collaboration metaanalysis showed that 10-year cardiovascular mortality was 18.7% when ABI<0.9, compared to 4.4% when ABI was normal
None of the drugs currently used for treatment of PAD (e.g. statins, cilostazol, etc.) correct these biomarkers
Patients with PAD exhibit increased levels of multiple biomarkers of oxidative stress and inflammation in blood plasma
A small clinical trial on patients with advanced PAD is under way at University of Louisville (USA), using walking distance following 3 months of intake of 2 g/day carnosine as the clinical end- point
PCCAR-09: Our new and smart approach to treatment of PAD
In a recent population study high circulating levels of amino acids tryptophan, serine, threonine and glutamate were inversely associated with the risk of PAD
The said composition will target 3 different mechanisms involved in the development of PAD: oxidative stress, inflammation and deficiency of certain amino acids
Our approach is to combine the aforementioned amino acids (but excluding glutamate which is proinflammatory) with carnosine in a proprietary composition to be tested as a non toxic supportive treatment of PAD (to be added to current drug treatment in advanced disease, or recommended as a prophylaxis in the early phase of the disease)
Primary end point of our early clinical experiment will be change in biomarkers of oxidative stress and inflammation
PCCAR-09: Current stage of development and the next steps
To assure optimal delivery of carnosine and aminoacids to PAD patients a technology of extended-release tablets (to be taken two times per each day) will be developed
For Early Clinical trial PAD patients will be stratified into two groups:
1. mild cases defined by ABI 0.9 – 0.7
2. moderate cases defined by ABI 0.69 – 0.5
Approx. 40 patients per group. Severe PAD cases defined by ABI<0.5 will be excluded
Active treatment or placebo will last 6 months
Primary (surrogate) end point of the study will encompass:
– biomarkers of oxidative stress and biomarkers of inflammation in blood plasma
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