Company
ASX:PXS
Syntara Ltd is a clinical-stage drug development company focused on the development of novel therapeutics aimed at correcting extracellular matrix (ECM) dysfunction. This will lead to positive outcomes in a range of diseases with high unmet need, including haematological malignancies such as myelofibrosis and myelodysplastic syndrome, chronic fibrosis (including skin scarring, pulmonary fibrosis, chronic kidney disease, NASH and cardiac fibrosis) and neuroinflammation.
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A research team at the University of Rochester Medical Center in New York State has been investigating the role of lysyl oxidase enzymes in liver cancer and whether PXS-5505 can improve the efficacy of current chemotherapy drugs by inhibiti
An effective pan‐LOX inhibitor for bone marrow cancer would open a market that is conservatively estimated at US$1 billion per annum.
Under the agreement, BTC Health will acquire marketing authorisations for both products in Australia, New Zealand, Singapore, Malaysia and Hong Kong.
The second dose cohort of the clinical trial is fully recruited and dosing of all patients has commenced at participating sites in Australian and South Korean hospitals.
The company’s PXS-5505 multinational trial in Myelofibrosis has been cleared by the safety committee to advance to the second stage of Dose escalation study.
PXS-5505 will enter pre-clinical efficacy testing for glioblastoma, the most common form of brain cancer with an average survival of only 15 months from diagnosis.
The company has also strengthened its balance sheet with the sale of Bronchitol Russian distribution rights for A$2 million with annual A$1 million cost savings.
The trial will investigate the potential of PXS‐6302 treatment to transform trauma recovery by blocking the underlying fibrosis causing scar tissue.
The researchers hope that the study will contribute to the development of novel treatment options for primary myelofibrosis.
In addition, data from the Pharmaxis Phase 3 global clinical trial (CF303) evaluating the efficacy and safety of Bronchitol in adults with CF has been published online in the Journal of Cystic Fibrosis.
“Its potential to modify the course of the disease by directly targeting bone marrow fibrosis will make PXS‐5505 an ideal monotherapy or adjunct to approved therapies in this indication,” says CEO.
“This represents a proud and very rare achievement for a home‐grown pharmaceutical research company,” says CEO Gary Phillips.
Pharmaxis is now advancing clinical development of a new cancer drug.
The company expects to announce receipt of milestone payments and the start of sales from its Bronchitol treatment in the near-term.
The webinar will also be live-streamed on the Proactive YouTube channel, which can be viewed at any time following the presentations.
Australian drug discovery will now be available for cystic fibrosis patients in the USA in a “transformational” event for the company with cash flow generated to take lead pipeline drug to end of phase 2 clinical trials.
The company is focused on the phase 1/2 clinical trial of its pan-LOX inhibitor PXS-505 in myelofibrosis and will use the tax incentive to progress the drug’s development.
The Australian Government matched funding under the Biomedical Translation Bridge program will allow the company to take amine oxidase inhibitor PXS-4699 through to the start of human clinical trials.
The Food and Drug Administration has completed a safety review of the company’s Investigational New Drug application for the pan-LOX inhibitor PXS-5505.
A timeline agreed with US licensee Chiesi Farmaceutici will see the US$7 million payment made upon US approval of Bronchitol by the Food and Drug Administration who have advised a Goal Action Date of November 1, 2020.
