HUNTINGTON’S DISEASE A 2nd INDICATION FOR PRANA’S PBT2
December 4th 2008 01:43
Friday November 28, 2008
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PRANA
Prana has told its annual general meeting that it is pursuing a second indication of Huntington’s disease for lead compound PBT2.
Prana has completed a phase IIa human clinical trial of PBT2 for Alzheimer’s disease.
Prana said a commissioned report from independent US-based clinical researchers entitled ‘The suitability and recommendations for the clinical development of PBT2 in Huntington’s disease’ concluded that PBT2 was a suitable candidate for investigation in clinical trials.
Prana said Huntington’s disease was an inherited degenerative brain disease causing uncontrolled movements, loss of intellectual faculties and emotional disturbance.
The chairman of Prana’s research and development advisory board Prof Jeffrey Cummings said the recommendation of the report was “a real plus for PBT2”.
“There are currently no drugs available to patients which prevent or delay Huntington’s disease,” Prof Cummings said.
“PBT2 has the potential to affect the disease process and therefore to treat the disease,” Prof Cummings said.
Prana said that both Huntington’s and Alzheimer’s diseases involved the toxic interaction of metals and specific protein aggregates in the brain that lead to nerve damage.
The company said its metal protein attenuating compound PBT2, exerted its activity by reducing the metal protein association, thereby reducing the damage to nerve tissue.
“Very importantly, PBT2 has a neuro-protective effect,” the company said.
“On the basis of a relevant mechanism of action, supportive non-clinical proof-of-concept studies in Huntington’s disease models, preliminary evidence of clinical safety and tolerability and promising clinical and biomarker outcomes in Alzheimer’s patients, PBT2 is recommended to proceed to clinical trials in Huntington’s disease research participants,” the report concluded.
Prana said that PBT2 might be used to treat both Huntington’s and Alzheimer’s patients.
Prana’s chief executive officer Geoffrey Kempler told Biotech Daily the company was “ready for the clinic” with PBT2 for Huntington’s but had not set a time-frame.
He said in a notice to the ASX that Prana was ready for larger clinical trials of PBT2 for Alzheimers to advance the drug towards commercialization for that indication.
Earlier this year the company announced preliminary phase IIa trial results and that the primary endpoints of safety and tolerability were met (see Biotech Daily; July 30, 2008).
Prana said PBT2 showed improvement in executive function, an important aspect of cognitive performance and reduced levels of amyloid beta in the spinal fluid of patients. Abeta is a key protein associated with Alzheimer’s disease.
Prana said that publication of the results “attracted a great deal of attention from industry”.
Mr Kempler said the company had “entered into confidentiality arrangements with several large pharmaceutical companies” and was in various stages of discussion in respect of the licencing of its lead compound PBT2.
Mr Kempler said Prana had therapeutic drug candidates from its Parkinson’s disease program based on the understanding of the relationship between metals, particularly iron, and the metal induced oxidation of dopamine, believed to be involved in damage to the substantia nigra, the area of the brain affected in Parkinson’s disease.
“Already, a lead candidate drug, PBT427, has demonstrated positive effects in pre-clinical in vivo studies, protecting against damage to the substantia nigra,” Mr Kempler said.
Prana said a recent cover story of Science-Business Exchange was dedicated to a description of Prana’s work on Parkinson’s disease.
Prana was unchanged at 30 cents.
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