PharmAust Receives Positive Results from Ongoing Phase I Trial Program

  • May 07, 2019 AEST
  • Team Kalkine
PharmAust Receives Positive Results from Ongoing Phase I Trial Program

PharmAust Limited (ASX: PAA) is a clinical-stage company, developing targeted cancer therapeutics to address both humans as well as animal healthcare.

On 7th February 2019, PharmAust Limited entered into an agreement with US Contract Research Organisation to start the Phase I clinical trial of its newly formulated Monepantel Tablet. Phase I of the clinical trial had four stages which include:

  • Validating the optimal dietary conditions for monepantel administration.
  • Dose escalation study to confirm the safety of monepantel at a single dose.
  • To find out the frequency of dosing that is required to achieve blood levels.
  • Based on the above three conditions, establish a 28-day repeat-dose drug level study determining the optimal tablet administration frequency to commence Phase II anticancer studies in pet owners’ dogs with cancer.

On 6th May 2019, PharmAust Limited announced that it had received a further positive result from its ongoing Phase I trial program in healthy beagle dogs. Based on this new data, the company is preparing trial design as well as the commencement of its Phase II trial program in dogs diagnosed with cancer.

The latest trial tested safety and serum levels of monepantel and monepantel sulfone in the blood of healthy dogs administered either one or five tablets every day for a period of nine days. The group has pinpointed earlier that monepantel and its major metabolite, monepantel sulfone provide anti-cancer activity. At this point of time, it is also essential to understand steady-state blood levels of both active molecules over long-term drug administration.

One tablet daily offers long-term blood levels that exceed the target level of the company. On the other hand, five tablets daily provide the long-term blood levels triple the target levels of the company. Through these observations, the company has gained enough flexibility in designing dosing schedules for therapeutic treatment of dogs suffering from cancer.

Also, there were no changes reported in the clinical signs at either dosing level by the US-based independent research organisation who conducted the study, with monepantel being well tolerated.

Apart from the commencement of Phase I Canine Trial, the company’s wholly-owned subsidiary was awarded an extension to its contract with Drugs for Neglected Diseases Initiative during the March 2019 quarter. The company, during the quarter, received a Research and Development tax Incentive refund of $672,250 for FY2017/2018

During the period, the company used $0.288 million in its operating activities. The company raised capital by issuance of shares and also made repayment borrowings. Thus, net cash inflow through the financing activities was $1.250 million. By the end of the March 2019 quarter, the company had net cash and cash equivalent of $1.930 million.

In the June quarter, the company expects a total cash outflow of $1.635 million.

PAA is currently trading flat on ASX at $0.034 (as at AEST:12:05PM, 07 May 2019), as compared to its previous closing price. PharmAust Limited holds a market capitalisation of $8.59 million and approximately 252.62 million outstanding shares.


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