Cogane, a plant based drug to treat Parkinson’s disease by Phytopharm is entering a Phase II study, the company announced.
Cogane is a novel small molecule, orally bioavailable neurotrophic factor inducer that readily crosses the blood brain barrier.
Cogane stimulates the release of neurotrophic factors and increases neurite outgrowth, studies in preclinical models found.
Cogane also reverses the decrease of neurotrophic factors and reverses dopaminergic neurnal degeneration observed in vitro.
Oral administration of Cogane over eighteen weeks significantly reduced parkinsonian disability by 43 % in the macaque model of MPTP-induced Parkinson’s disease (the gold standard for preclinical Parkinson’s disease research), which will be clinically highly relevant if repeated in Parkinson’s disease patients, in a recently completed efficay study.
The study also noted a statistically significant reduction in parkinsonian symptoms was reached after nine weeks of administration with Cogane. The magnitude of the effect increased over the subsequent nine weeks of administration and was still increasing at the end of the study (week eighteen).
Phytopharm has also completed a Phase Ib stafety, tolerability and pharmacokinetic clinical study with Cogane, which was shown to be safe and generally well tolerated in both healthy volunteers and Parkinson’s disease patients over the twenty eight day study period.
When administered orally in several differenct preclinical models of Parkinson’s disease Cogane reverses the loss of dopaminergic neurones and elevates glial derived neurotrophic factor (GDNF)
GDNF has been shown to be particularly effective in re-growing damaged nerves. Since GDNF is a protein, it cannot be given orally (in tablet or liquid form) because it is degraded in the stomach and intestine, and also does not readily cross the blood-brain barrier.
GDNF can work only when injected into or when produced inside the brain. Direct injection of GDNF into the area of the brain involved in Parkinson’s disease has shown evidence of being clinically effective in restoring the control of movement but requires highly complex and difficult surgical procedures.
Cogane readily crosses the blood-brain barrier and in preclinical models has been shown to stimulate the release of GDNF in the brain and therefore has the potential to overcome many of the difficulties associated with GDNF administration.
The neuroprotective and neurotrophic actions of Cogane suggest potential beneficial effects in other neuro-degenerative diseases including Alzheimer’s disease and Hintington’s disease, Phytopharm said in a press release.
In a clinical study on mild and moderate Alzheimer’s disease patients, Cogane showed a decline in cognition in the placebo group with an encouraging trend for slower disease progression in the Coganetreated group.
Patients with a mild form of the disease showed no decline in cognitive function and therefore, there was no effect detectable with Cogane.
The benefits to the moderate Alzheimer’s disease patients, coupled with Cogane’s good safety profile and tolerability, provides positive data for longer term studies for efficacy determination in both Parkinson’s disease, Alzheimer’s disease and Huntington’s disease.
Progress to date
In July 2009, CHDI Foundation Inc., in the USA entered into an agreement to evaluate the efficacy of Cogane in a preclinical model of Huntington’s disease.
CHDI is funding the testing of Cogane (in it network of industrial contract research organisations) employing its standardised criteria for the rigorous evaluation of novel thereapeutic approaches for Huntington’s disease treatment.
Phytopharm expects to start a Phase II study of Cogane with patients in the US in mid-2010 and then extend it into several other countries.
Cambridgeshire, UK-based Phytopharm is a pharmaceutical development and functional food company.
Phytopharm’s products are developed from medicinal plants, thereby reducing the development risk, cost and time to market.
As a virtual company, Phytopharm’s model is centred on a lean cash burn with all laboratory, manufacturing and clinical work outsourced to specialists, while core competencies such as strategy and management are maintained in-house.
Phytopharm closely collaborates with charitable organisations to accelerates its development programmes.