HUNTER IMMUNOLOGY READY FOR PHASE III COPD TRIAL
July 8th 2008 11:59
Monday July 7, 2008
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HUNTER IMMUNOLOGY
Hunter Immunology hopes to begin a phase III trial of an oral biologic drug for chronic obstructive pulmonary disease in 2009.
A public unlisted company, Hunter Immunology has submitted an investigational new drug application with the US States Food and Drug Administration for the phase III trial.
Hunter Immunology’s executive chairman and former Mesoblast executive chairman Michael Spooner told Biotech Daily that chronic obstructive pulmonary disease was the world’s fourth leading cause of death.
He said the Sydney-based company used intellectual property originating from the University of Newcastle with the protein treatment for chronic obstructive pulmonary disease HI-164OV its lead drug to be followed by one for asthma.
Mr Spooner said the trial was expected to in 2009 with patients given one dose a month for three months of either the active drug or a placebo with nine months follow-up.
Mr Spooner said the drug had shown safety and statistical efficacy in phase I and phase II trials of more than 200 patients, with no adverse event recorded.
He said the drug was intended to develop “a true immunological response” through stimulating the immune system and was aimed at reducing anti-biotic use for chronic obstructive pulmonary disease.
In a media release Hunter Immunology said a successful investigational new drug application would allow it to proceed with a late-stage clinical trial program to register HI-164OV in the US for the ongoing treatment of chronic obstructive pulmonary disease.
Hunter Immunology said markets associated with the treatment of respiratory disease “represent many of block-buster drugs currently available including the biggest ever selling prescription pharmaceutical”.
Australia spends $1.3 billion annually in direct treatment of chronic obstructive pulmonary disease, with the annual international cost of treatment reported to be more than $US40 billion, Hunter immunology said.
Mr Spooner said the submission of the investigational new drug application was “a very exciting milestone”.
“The data from our early clinical trials suggests that the product has an excellent safety profile and may significantly improve the quality of life for the many millions of people suffering moderate to severe COPD.”
“Importantly, Hunter’s product (HI-164OV) will seek to dramatically improve the effectiveness of existing medical therapies including bronchodilators as well as corticosteroids, whilst dramatically reducing the use of antibiotics and hospitalisation events,” Mr Spooner said.
Hunter Immunology said its first submission to the FDA was achieved on time and within budget. Subject to FDA clearance, the company said it would begin its clinical trial program as quickly as possible in the US and Australia, with additional studies possible in other countries.
The multi-centre, double blinded, placebo controlled, clinical trial would enrol patients with moderate to severe chronic obstructive pulmonary disease.
Patients will be followed for nine months and study endpoints include improvements in the frequency, severity and duration of exacerbations (lung infections).
The company’s submission incorporates outcomes associated with the previous clinical trial programs and said the data showed that HI-164OV had “an excellent safety profile and significantly reduces the duration and severity of exacerbations”.
Hunter Immunology said exacerbations or lung infections were the primary cause of hospitalization, progression of disease and reduction in the quality of life.
The company said its drug may also significantly reduce the use of antibiotics.
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