Antisense Therapeutics commences stem Cell mobilisation trial

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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