PharmAust set to restart cancer drug trials in pets

Clinical-stage oncology company, PharmAust (ASX:PAA) has released its quarterly, highlighting the company's recent successes.

PharmAust, which recently completed a capital raise to the tune of $2.4 million primarily to Australian and Singaporean fund management institutions, develops novel targeted cancer therapeutics for both humans and animals.

It is currently repurposing clinical candidate Monepantel (MPL) for targeted therapeutics in humans and animals. MPL is non-toxic to normal cells and a potential replacement to toxic chemotherapy treatments - a circa $47 billion per annum market.

PharmAust currently has $3.6 million cash in bank, to help facilitate its trials.

The following video gives a broader understanding of PharmAust and what it is trying to achieve:

PharmAust’s leading clinical candidate Monepantel is a small molecule drug currently being developed as a novel, safe and potent treatment for cancer. A key clinical attribute is its low toxicity as evidenced by its approved use in food chain animals and by PharmAust’s own Phase I trial.

The company is making significant progress with Monepantel, particularly in relation to its Phase II clinical trials, which it is now able to re-start following approval from the NSW Department of Primary Industry’s Secretary's Animal Care & Ethics Committee.

Phase II clinical trials will focus on using PharmAust’s newly formulated tablet in dogs with cancer.

The independent Ethics Committee approved the investigation of monepantel tablets for:

(i) testing anti-cancer efficacy in short-term studies and

(ii) testing anti-cancer maintenance in long-term studies. Anti-cancer efficacy is measured by achieving stable disease and progression-free survival or regression of the tumour(s). Preventing spread (metastasis) of the cancer will also be monitored.

PharmAust has received 7,750 of its newly developed GMP grade monepantel tablets, with veterinarians to begin the Phase II anti-cancer trial shortly.

The trial will be conducted in association with the University of Melbourne’s U-Vet Werribee Animal Hospital and will be overseen by Dr Claire Cannon, Head of Small Animal Medicine & Oncology.

Interestingly, PharmAust has already demonstrated that six of seven dogs with treatment-naïve B cell lymphoma achieved stable disease, or progression free survival, with reductions in tumour size following 14 consecutive days of gelatin encapsulated liquid Monepantel treatment.

The goal now is to repeat and extend this study using the newly developed high dose, highly palatable GMP Monepantel tablet formulation.

In other words, the tablet should taste much better than it has done in the past.

Canine patients

Canine recruitment will be based on factors such as expected survival, progression of the lymphoma and the animal’s general health.

Generally speaking untreated dogs with lymphoma only have a 50% chance of surviving for four weeks or more.

Taking this into account, the vets in charge will look to generate a population of canine patients that could provide meaningful statistical analysis as reliable and measurable outcomes.

Dogs will receive their first assessment after 14 days of treatment. This first assessment will determine if the tablet performs the same or better than observed in the previous trial.

The first 14 days will be followed by a further 14 day administration of the drug.

All up, a 28 day trial period will be facilitated, which will enable comparison of tablet performance with registered canine anti-cancer drugs already on the market.

If mutually agreed by the pet owner and the vet, each respective dog will be placed on a long-term maintenance lower treatment dose.

Achievement of 3 to 6 month progression-free survival would provide PharmAust with a highly successful drug for canine treatment. Trial data will be released dependent on the recruitment rate of dogs with treatment naïve B cell lymphoma and the incremental drug success rate across the participating sites.

To speed up the trial process, PharmAust is expanding the recruitment of dogs to further sites in Australia.

The company will release trial data when a clear and meaningful trend is apparent, however results are expected in the final quarter of 2019.

Successful results will activate its partnership with the $10 billion capped Elanco Animal Health, a major player in the field. Elanco has an option to licence MPL as an anti-cancer vet therapeutic, which would be a major corporate outcome for PharmAust.

The Epichem connection

In more good news for PharmAust, Epichem, its wholly owned subsidiary which delivers products and services in synthetic and medicinal chemistry to the global drug discovery and pharmaceutical industries in 35 countries worldwide, has paid off its debt liability on time for a major state-of-the art laboratory.

The newly constructed laboratory has world-class equipment and expertise in synthetic and medicinal chemistry for the cost-effective synthesis of drug analogue libraries and intermediates. It also has a rapidly growing catalogue of pharmaceutical reference standards.

Epichem, which will now be led by new CEO Colin La Galia, has won the coveted WA Exporter Award on five occasions and is in the WA Export Hall of Fame. It has also won the prestigious Australian Export Award in the Small Business category.

The company’s revenues increased 74% between 2015 and 2019 and sit at $3.8 million in FY19. Budgeted revenues for FY20 are $4.2 million (subject to continuation of existing contracts).

It is expected that under La Galia's leadership, revenues should increase further. La Galia was previously the Regional Business Director and Commercial Head of Asia Pacific, China and Japan for Abbott Rapid Diagnostics and held senior roles at Alere Inc, Origin Healthcare, Hollywood Fertility Centre, GlaxoSmithKline and Merck Sharpe & Dohme.

With the loan facility repaid, the money saved on interest and principal will go straight to improving the bottom line.

At the same time Dr Martine Keenan resumed her former role as Epichem’s Head of Drug Discovery and also joins the Epichem board.