ASX Health Stocks: Amplia begins Phase 2 trial for pancreatic cancer, while Avecho commences Phase 1 of cannabis gel
Health & Biotech
Health & Biotech
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The ASX 200 health stocks index (XHJ) has lifted by 0.19% at the time of writing, compared to the broader ASX 200 index which fell by 0.70%.
The cancer and fibrosis focused company, Amplia Therapeutics (ASX:ATX), has completed the design for a Phase 2 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945.
The trial will be conducted on newly diagnosed patients receiving first-line therapy for pancreatic cancer.
In the trial, AMP945 will be administered orally to these patients prior to each dose of their standard gemcitabine/nab-paclitaxel chemotherapy.
The design of this trial is based on studies conducted by Professor Paul Timpson’s group at the Garvan Institute of Medical Research in Sydney.
Those studies have shown that intermittent dosing of AMP945 makes tumours more responsive to standard chemotherapy treatments in animals with pancreatic cancer.
Phase 1 results of AMP945 earlier this year also showed the drug was safe and well tolerated at all doses tested.
Amplia now plans to initiate patient recruitment at Australian sites in the first quarter of 2022, and expects this recruitment process to take between 18-24 months.
“If we are able to see positive signs that AMP945 improves the leading current treatment option, we will commence discussions with regulators and potential partners concerning future trials required to support product approval,” commented Dr John Lambert, CEO of Amplia Therapeutics.
The company has enrolled its first healthy volunteers for the Phase 1 study of its 75 mg cannabidiol (CBD) soft-gel product.
The study is designed to characterise the absorption profile of CBD from the CBD soft-gel product.
It will also support Avecho’s strategic focus of developing pharmaceutical CBD products that leverage its proprietary TPM (Targeted Penetration Matrix) formulations.
The 75 mg CBD soft-gel product has been developed and manufactured by partner Catalent Inc at its facility in Florida.
“We have invested time this year with Catalent further optimising and completing the product,” says Avecho CEO, Dr Paul Gavin.
“Catalent is a respected global leader in the development of drug technologies, and we believe the collaboration and additional effort will ensure the dosage form reflects the highest possible standard.”
In this Phase 1 study, 16 volunteer patients will receive two separate doses over a period of two weeks, with dosing due to begin in early October.
High level results are expected to be received in December 2021.
The regenerative medicinal company has announced the completion of its pre-clinical Anterior Cruciate Ligament (ACL) reconstruction study.
This pre-clinical study in rabbits indicate that a novel CelGro collagen ‘rope’ is a viable alternative to conventional tendon grafts for ACL reconstruction.
It showed that the CelGro collagen rope was equal to or better than the gold-standard autograft – which is the patient’s own tendon (usually hamstring) – for ACL reconstruction.
In the study, 30 rabbits received CelGro collagen rope and another 30 rabbits received hamstring tendon autografts.
The performance of CelGro collagen rope was compared to hamstring tendon autograft at 6, 12, 18, and 26-weeks post-ACL reconstruction.
The encouraging results showed that CelGro collagen rope is potentially superior “off- the-shelf” alternative to the current tendon autograft options.
“An off-the-shelf biological device that augments ACL reconstruction and is biologically compatible is highly desired by the orthopaedic industry,” said Orthocell CEO Paul Anderson.
“Orthocell is ideally placed to deliver the CelGro collagen rope in this rapidly growing and lucrative market.”
CelGro is a customisable collagen medical device manufactured by the company at its facility in WA, using the Orthocell’s proprietary SMRT tissue engineering process.
Past studies have shown that use of of CelGro has resulted in positive outcomes in the repair of bone defects in the jaw, damaged peripheral nerves, and in the cuff tendon within the shoulder.