ASX-listed biotech, PharmAust, has added a fifth site to its expanding network of anti-cancer trial sites for canines, securing the Brisbane Animal Hospital as the latest location for its Phase II anti-cancer trial in dogs with B cell lymphoma. The addition of the site in Brisbane expands the trial that is already underway in Perth, Melbourne and two centres in Sydney.
ASX-listed PharmAust's innovative biotechnology work via its wholly owned subsidiaries Epichem and Pitney Pharmaceuticals has been recognised by the Australian Tax Office with the company receiving more than $700,000 in a research and development tax rebate. The funds will be used to advance its clinical trial programs in dogs and humans with the company now on a fast tracked pathway to prove up the cancer fighting abilities of its “re-purposed” Monepantel drug.
ASX listed biotech, PharmAust, has been awarded a one-year extension to its contract with not for profit organization, the Drugs for Neglected Diseases Initiative, which commemorates the 12th-year of association between the two parties. Under the contract, which is expected to bring in $1.24m in revenue, PharmAust's subsidiary, Epichem, will provide synthetic and medicinal chemistry services focused on developing new treatments for neglected diseases.
PharmAust subsidiary Epichem has significantly revised its forecast revenue following the announcement one of its major customers would end its contract with the company next month.
PharmAust has expanded its national network of participating veterinary and university institutions who will join the ASX-listed biotech's anti-cancer crusade for dogs. With the pace of phase II clinical trials for its promising “Monepantel” anti-cancer treatment projected to rise, the company is looking to impact K9 – and possibly even human – cancers. Phase I trials were very positive, with a notable reduction in cancerous tumours and prolonged lifespans.
ASX listed biotech, PharmAust, has put a call out for canine volunteers to join its anti-cancer drug treatment trials in partnership with veterinary practices across Australia. The trials will study the effectiveness of Pharmaust's anti-cancer drug in dogs suffering from B cell lymphoma – the most common canine cancer. Preliminary findings from phase I trials were very positive, with a notable reduction in tumours and prolonged lifespan.
Our weekly appointments wrap includes Michael Hughes, Craig Lennard, Tim Searle, Jade Macukatt, Alex Gregg, Gemma Cooper, Alex Ward-Noonan, Steve Blyth, Dean Lavers, Robert Wilton, Colin La Galia, and Martine Keenan.
ASX-listed PharmAust's fully-owned subsidiary, Epichem, has appointed experienced pharmaceutical and healthcare executive, Colin La Galia, as its new CEO and he will replace Dr Martine Keenan, who will step down from the role to resume her former position as Epichem Head of Drug Discovery and join the company's board. Epichem is a successful contract medicinal chemistry company that is forecasting $4.2m revenues for the current financial year.
The battle against canine and other cancers by ASX-listed WA biotech company, PharmAust, has received a significant boost after the Australian Government deemed it eligible for further research and development tax rebates worth almost $1.5 million. The rebate relates to PharmAust's clinical testing and trials of its anti-cancer drug, Monepantel and may even apply to PharmAust's activities overseas.
Epichem, a subsidiary of ASX-listed biotech, PharmAust, has been rewarded for its contribution to WA and nominated as the year's winner of the prestigious WA Industry and Export Awards. The company was acknowledged for its contributions to the global health and biotechnology sector by providing “end-to-end” support in drug discovery, with CEO, Dr Martine Keenan, also recognised with the Women in International Business Award at the same ceremony.
PharmAust has finalised contractual arrangements with the University of Melbourne's U-Vet Werribee Animal Hospital to commence the Phase II clinical trials into the effectiveness of its Monepantel anti-cancer drug in dogs. The trial will be overseen by U-Vet's Head of Small Animal Medicine and Oncology, Dr Claire Cannon, who will also oversee recruitment at other nominated sites within Australia.
PharmAust has kicked-off its much-anticipated Phase II clinical trials that will study the effectiveness of the new palatable and high dose tablet formulation of its Monepantel anti-cancer drug in dogs. The trial will determine the efficacy of the drug over a prolonged period of time in dogs with B cell lymphoma before testing progresses to low dose maintenance of progression free survival and efficacy in other cancers.
PharmAust's subsidiary, Epichem, has received a shipment of Monepantel tablets from the US and will now distribute the drugs to veterinarians starting this week to commence its Phase II anti-cancer drug trials in dogs. The company completed successful tablet safety and blood level tests earlier this year and with tablet shelf-life stability tests now finalised, the company can commence the trials.
PharmAust has received the key ethics approval from the New South Wales Department of Primary Industry to proceed with the Phase II clinical trials for its anti-cancer drug Monepantel in dogs with B-cell lymphoma, the most common form of canine cancer. The company will begin recruitment of dogs for the Phase II trial after it takes delivery of the tablets from the US in August or September.
PharmAust's wholly owned synthetic and medicinal chemistry subsidiary, Epichem, is set to further improve its bottom line after paying off the $750,000 loan from Export Finance Australia taken out to help finance the construction of a state-of-the-art laboratory in 2015. This laboratory fuelled growth over the period from 2015 to 2018, with revenues increasing 38% to $3 million in the 2018 financial year.
PharmAust has given US-based manufacturer Catalent the green light to start producing more Good Manufacturing Practice-grade Monepantel tablets for its upcoming Phase 2 anti-cancer clinical trials in dogs. The company plans to start recruiting dogs with B cell lymphoma in August or September this year for the Phase 2 trials, which will initially follow a 28-day treatment regimen.
PharmAust can now assess dosing strategies for the upcoming Phase II clinical trials for its anti-cancer drug Monepantel in dogs after receiving further positive results from the ongoing Phase I trial. Serum levels of both Monepantel and its major metabolite, monepantel sulfone, exceeded the predicted anti-cancer activity target values in dogs administered just one tablet per day.
PharmAust has received a tidy $672,250 R&D tax refund from the Australian Government for its expenditure on the development of its flagship Monepantel anti-cancer drug. This includes work on its successful clinical trials and reformulating a high dose tablet with improved taste. The refund will be used to advance the company's clinical trial programs in dogs and humans.
PharmAust continues to tick off the milestones at its ongoing Phase I clinical trials for its anti-cancer drug Monepantel in dogs with the escalation study showing no adverse safety issues. Beagles treated with up to 10 Monepantel tablets displayed no adverse effects or signs of toxicity after being monitored over three days. The company will now start dosing tests to determine how best to maintain long term monepantel blood levels.
PharmAust is basking in the early success of Phase I clinical trials for its flagship anti-cancer drug Monepantel in dogs. Preliminary results show that the blood concentrations of Monepantel in the test subjects already exceeded levels observed to achieve anti-cancer activity after administrating just one tablet. The company has now started the dose escalation component of the Phase I trial on schedule.
PharmAust has kicked-off its highly-anticipated Phase I clinical trials for its flagship anti-cancer drug Monepantel in dogs using the first batch of 2000 tablets manufactured to its new and better-tasting formulation. The initial component of the trial is designed to validate the performance of the drug in different dietary settings that dogs may encounter at home. First results are expected in the middle of March this year.
PharmAust's wholly-owned subsidiary Epichem will continue to provide its synthetic and medicinal chemistry expertise to leading research and development organisation Drugs for Neglected Diseases initiative, or “DNDi”, which extended its current contract for an 11th year. The contract extension is expected to generate up to $1.24 million in revenues for Epichem this year.
Dogs have readily taken PharmAust's Monepantel tablets using the new formulation for the anti-cancer drug either directly from administrators' hands or from the floor. This bodes well for future trials of the drug in humans as the canine taste testers have an apparently higher taste sensitivity than humans. The Phase I clinical trial for Monepantel in dogs is poised to start later this month.
PharmAust has executed an agreement with a major US contract research organisation to start Phase I clinical trials for its flagship anti-cancer drug Monepantel in dogs on 19 February 2019 using its final tablet format. This will provide information on the number of tablets, administration frequency, blood levels and verification of safety for the Phase II trials in pet owners' dogs with naturally occurring cancers.
PharmAust has signed an agreement with US pharmaceutical heavyweight Elanco that allows the biotech company to reference certain safety and blood chemistry data that were generated for the regulatory approval of Monepantel in Australia, New Zealand and the EU, as an anti-parasitic drug in livestock animals. This could potentially expedite the early proof of principle phase two trials of the anti-cancer drug in dogs.
PharmAust has received new data from Canada's BRI Biopharmaceutical Research that a specific combination of diet and excipient could double the amount of its Monepantel anti-cancer drug that can be delivered into the bloodstream of dogs. This could increase the flexibility for dosing schedules of Monepantel and potentially simplify the treatment of canine cancers.
ASX listed Biotech upstart PharmAust says that its ongoing clinical research in Melbourne is demonstrating that its anti-cancer drug, Monepantel's principle end-product, metabolite Monepantel Sulfone, retains the same biological activity as the drug itself. The metabolite shows little side effects upon healthy, non-cancerous cells and works together with Monepantel, producing a “double kick” in eliminating cancer cells. Reduced dosing treatments are envisaged for upcoming canine and human trials.
PharmAust has confirmed that its flagship anti-cancer drug, Monepantel, produced using the recently determined “GMP” process, continues to demonstrate the drug's expected ability to kill cancer cells while having little or no impact on non-cancerous cells. Further pre-clinical molecular pathway targeting studies will now be carried out to improve the company's understanding of how the drug kills cancer cells.
PharmAust has signed an agreement with US company Catalent Pharma Solutions for the GMP-grade manufacture of its “Monepantel” anti-cancer drug for its upcoming clinical trials in dogs. Manufacturing the drugs to GMP standards will enable the resultant data to be admissible to the US FDA in support of new drug registration programs, a key milestone for PharmAust.
PharmAust has developed a prototype “good manufacturing practice” method for the large-scale manufacture of its anti-cancer drug, Monepantel and its analogues at an economical cost and to standards required for clinical trials. The method can also be used for molecules in the drug library that PharmAust secured from Nihon Nohyaku in September 2017, which are related to but different from Monepantel.
ASX listed biotech PharmAust now has sufficient data from testing of different tablet prototypes of its flagship Monepantel anti-cancer drug to take the best performing and most economical tablet for GMP manufacturing. The selected tablets will be used in formal dose escalation studies in healthy Beagle dogs to determine the maximum dose that can be given and with what safety margin.
PharmAust has appointed Westar Capital chairman Neville Bassett as a non-executive director, replacing Dr Wayne Best who is retiring. Dr Best will remain as chairman of the company's wholly owned subsidiary Epichem. Pharmaust is poised to start clinical trials for its Monepantel anti-cancer drug on canine subjects soon.
Researchers at the Olivia Newton-John Cancer Research Institute in Melbourne have independently confirmed the ability of Pharmaust's anti-cancer drug, Monepantel, to impact cancer cells. This includes other previously untested human melanoma cancer cell lines. The research also found that the drug became progressively more effective over a longer time whilst having minimal impact on two non-cancerous ovarian cell lines.
Pharmaust will complete preliminary clinical trials on dogs in the coming weeks to help determine the required dosage for its newly reformulated Monepantel tablets and to confirm that it is non-toxic. The company will also start a Phase I “pharmacokinetic study” with the new tablets during the fourth quarter and it will also follow this up with initiation of its long awaited Phase II clinical trials.
ASX listed Pharmaust is preparing to carry out phase II clinical trials on dogs for its anti-cancer drug Monepantel, expected to kick off in quarter 4. Data from the canine phase II trial will be combined with lab tests to confirm Monepantel's effectiveness at killing selected human tumour cells to form the basis for clinical trials in humans.
PharmAust's wholly owned subsidiary, Epichem, is one of the first Australian companies to receive an international quality assurance accreditation coveted by manufacturers of pharmaceutical drugs. ISO17034:2016 covers the production of reference material used to check the quality of products or the calibration of instruments. Pharmaust is also rapidly progressing its promising Monepantel ant-cancer drug.
Perth-based Epichem, a wholly owned subsidiary of ASX-listed biotech PharmAust, has received a contract extension with a leading US biotechnology company, Unity Biotechnology. The new contract, worth around US$1.65 million out to 2020, means Epichem will continue to provide synthetic and medicinal chemistry expertise to support Unity's drug discovery projects.
ASX-listed biotech PharmAust, has successfully reformulated its promising anti-cancer drug “Monepantel”. Perth-based PharmAust says the new form of Monepantel, which now takes the form of dry tablets, improves the drug's taste and meets dosage requirements, paving the way for trials in dogs expected to take place by the end of the year ahead of human clinical trials.
Perth-based medicinal cannabis specialist Zelda Therapeutics has appointed former Phylogica and PharmAust chief executive Richard Hopkins as its managing director.
