Pharmaxis’ first results in bone marrow cancer trial show strong inhibition of target enzymes
Pharmaxis Ltd’s (ASX:PXS) (FRA:UUD) first results from a three-stage phase 1c clinical trial (MF-101) studying a potential treatment for bone marrow cancer myelofibrosis, have demonstrated strong inhibition of target enzymes LOX and LOXL2 in patients.
The phase 1c/2a trial MF-101 cleared by the FDA under the Investigational New Drug (IND) scheme aims to demonstrate that PXS-5505 is safe and effective as a monotherapy in myelofibrosis patients who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs.
An effective pan-LOX inhibitor for myelofibrosis would open a market that is conservatively estimated at US$1 billion per annum.
While Pharmaxis’ primary focus is the development of PXS-5505 for myelofibrosis, the drug also has potential in several other cancers including liver and pancreatic cancer, where it aims to breakdown the fibrotic tissue in the tumour and enhance the effect of chemotherapy treatment.
PXS shares have been as much as 32% higher to A$0.099 intra-day.
“Delighted” with results
Chief executive officer Gary Phillips said: “We are delighted to see that along with excellent tolerability, we are achieving levels of LOX and LOXL2 inhibition in myelofibrosis patients that are already exceeding those levels seen in the preclinical models of myelofibrosis.
“In these models, PXS-5505 caused disease modifying effects with improvements in blood cell count, diminished spleen size and reduced bone marrow fibrosis.
“Comparing these results with those achieved in the phase-1 study with healthy volunteers, we are now very confident that we will achieve a level of inhibition of the lysyl oxidase enzyme family that will allow us to fully test the clinical relevance of these targets in myelofibrosis patients in the upcoming 6-month dose expansion study.”
Successful recruitment
The second dose cohort of the clinical trial is already fully recruited, and dosing of all patients has begun at participating sites in Australian and South Korean hospitals.
Following 28 days on this second dose, the safety and pharmacokinetics will be assessed before starting myelofibrosis patients on the final and highest dose.
The dose escalation phase of the study will inform the selection of the optimal dose of PXS-5505 to be used in the six-month dose expansion to evaluate safety and efficacy which is expected to report results by the end of 2022.
Sites in other countries, including the USA are currently being engaged in anticipation of the dose expansion phase commencing recruitment later this year.
Story by ProactiveInvestors
Source: http://www.proactiveinvestors.com/companies/news/953570/pharmaxis-first-results-in-bone-marrow-cancer-trial-show-strong-inhibition-of-target-enzymes-953570.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).