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12/16/2013 8:36:42 AM
MELBOURNE, AUSTRALIA: December 16, 2013—Drawbridge Pharmaceuticals Pty Ltd (Drawbridge) is pleased to announce that it has commenced a Phase 1C clinical trial of alphaxalone dissolved in sulfobutyl ether beta cyclodextrin; Phaxan™.
The project is a randomized double blind, dose-finding study using a Bayesian design. The purpose of the trial is to compare the anaesthetic properties of Phaxan™ with propofol, which is the current standard for intravenous anaesthesia.
The trial will be conducted at the Jessie McPherson Private Hospital under the guidance of Investigator, Dr John Monagle, Director of Monash Anaesthesia and Pain Management, at Monash Health.
“The aim of the trial is to reintroduce into clinical practice an intravenous anaesthetic which we believe has a higher safety profile than the drugs in current clinical practice,” said Prof. Colin Goodchild, Chief Medical Officer at Drawbridge Pharmaceuticals.
Twenty-four subjects will take part in the trial, with twelve subjects to receive, propofol and 12 to receive the study drug, Phaxan™. Pain on injection— a common problem with propofol, the quality of the anaesthesia and effects on cardiovascular and respiratory systems will be observed and compared between the drug treatments.
“The trial will be the first time that Phaxan™ has been tested clinically in a critical care setting; if ultimately shown to be safe and efficacious in humans, it could provide an alternative new treatment option for patients requiring intravenous anaesthesia,” said Dr Anthony Filippis, CEO at Drawbridge Pharmaceuticals.
The need for a for a new anaesthetic that is both safe and effective continues to grow significantly with more than 80 million general anaesthesia procedures performed annually in the United States and Europe alone.
Although propofol is commonly used in anaesthesia, there are significant problems associated with its use including: a propensity to cause falls in blood pressure, depression of breathing, the lipid based preparation is easily contaminated and supports bacterial growth; is incompatible with plastic containers and leads to lipid toxicity.
Phaxan™ has none of these problems when tested in preclinical studies. The active pharmaceutical ingredient in Phaxan™, alphaxalone, has been administered previously to humans as Althesin®, which was withdrawn from the market due to allergic reactions caused by the excipient. By changing the excipient in the formulation, Phaxan™ overcomes this issue and Drawbridge looks forward to re-introducing alphaxalone to the market as Phaxan™.
About Drawbridge Pharmaceuticals
Drawbridge Pharmaceuticals was founded in 2011 and is a privately-held biotechnology company, headquartered in Melbourne, Australia. The company is developing innovative neuroactive steroid compounds for use in critical care situations. Phaxan™ is the lead compound for use as a fast onset and offset intravenous general anaesthetic and sedative.
Phaxan™ is a novel water based formulation of the neuroactive steroid, alphaxalone. It has a wide therapeutic index and rapid onset and offset of action. The anaesthetic agent in Phaxan™ has been administered in the past as Althesin® when formulated in a different excipient. It was withdrawn in 1984 because of problems with the formulation. Phaxan™ does not have the problems of the Althesin® formulation and is superior to propofol in preclinical models.
Phaxan™ is a registered trade mark for alphaxalone formulated in sulfobutyl ether beta cyclodextrin being developed by Drawbridge Pharmaceuticals.
About the Phax001 (Phaxan™) clinical trial
The clinical trial in healthy volunteers will compare the quality of anaesthesia with propofol and Phaxan™(12 subjects per group). The study will be conducted in a fully equipped operating room with two anaesthetists, one for drug administration and the other to care for the subject. The caring anaesthetist and subject will be unaware of which drug is given.
A range of doses will be used for each drug. The time of onset of anaesthesia and full recovery will be compared for each drug. The depth of anaesthesia will be measured using a brain activity monitor (bispectral index; BIS) and the two drugs will be compared for their effect on blood pressure and breathing at the doses that have an equal effect on brain activity. It is expected from the preclinical comparison of the two anaesthetics that Phaxan™will cause anaesthesia with much less effect on blood pressure and breathing suggesting that this should be developed as a safer intravenous anaesthetic for use in humans.
Further details on the trial can be found at www.anzctr.org.au
Dr Anthony Filippis and Prof. Colin Goodchild are available for interviews
Christine Filippis, Mendleson Communication: ph (03) 9421 6520, email email@example.com
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