Antisense Therapeutics commences stem Cell mobilisation trial
THE PHARMACY: Antisense Therapeutics (ASX: ANP) has commenced dosing in its Phase I Stem Cell Mobilisation (SCM) Human Proof of Concept trial of ATL1102, the company’s second generation antisense drug targeting the VLA-4 receptor.
Antisense said the trial will assess the safety, tolerability and effect of ATL1102 on the release of hematopoietic stem cells (CD34+) into the blood when dosed alone and in combination with an existing therapy (Granulocyte Colony Stimulating Factor (G-CSF)).
The randomised, open label study of ATL1102 dosed over 5 days (given on day 1, 3 and 5) in 10 healthy volunteers is being conducted by clinical research organisation, Nucleus Network at its clinical trial unit at the Alfred Hospital in Melbourne, Victoria.
With the necessary screening, dosing and follow up of patients, Antisense anticipates results from the trial will be available to be reported mid-2014.
“The stem cell mobilisation opportunity for ATL1102 while commercially attractive with, by our estimation, a market potential of several hundred million dollars per annum, also presents as an excellent return on investment proposition given costs are expected to be relatively low for developing the drug in this indication,” Antisense Therapeutics CEO and managing director Mark Diamond said in the company’s announcement to the Australian Securities Exchange.
“We believe that positive outcomes from this trial will strongly enhance our drug’s potential for this application and naturally we relish the opportunity to further develop a drug that can potentially provide better outcomes for cancer patients.
“We look forward to successfully conducting the study and to reporting results from this SCM trial which are anticipated mid-year.”
Antisense explained the mobilisation (release) of these stem cells from the bone marrow into the blood is part of an important medical procedure used to improve outcomes for patients undergoing chemotherapy to treat certain cancers.
The stem cells released into the blood are then collected and stored before high dose chemotherapy and then re-infused to replace those lost during chemotherapy in order to re-establish the immune system.
The basis for using ATL1102 in the SCM indication is related to the role of VLA-4 in regulating the release of CD34+ stem cells from the bone marrow, with another drug that also targets VLA-4 having been shown to increase CD34+ stem cell release in humans.
The company said in a previous study involving Multiple Sclerosis patients, ATL1102 demonstrated similar activity to that drug by increasing CD34+ levels in the blood.
“This human Phase I trial of ATL1102 is designed to evaluate whether ATL1102 can improve mobilisation of CD34+ stem cells when used in combination with standard mobilisation therapy to levels that would make it clinically beneficial for use in the collection of stem cells for transplantation,” Nucleus Network medical director and principal investigator for the trial Dr Jason Lickliter said in Antisense’s ASX announcement.
“There is an acknowledged clinical need for increasing mobilisation levels beyond those achieved by the current therapeutic approach, and so I am very pleased to be working with Antisense Therapeutics to assess the merits of ATL1102 in this important clinical setting.”
Website: www.antisense.com.au