VIRALYTICS LTD ADR : First patients commence treatment in US Phase II trial
January 19, 2012 at 03:25 am
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ASX and Media Release
18 January 2012First patients commence
CAVATAKTM injections in U.S. Phase II melanoma
trial
Viralytics Limited (ASX: VLA, OTC: VRACY):
The Company is pleased to provide an update
of its lead product, CAVATAKTM in the 3 clinical
trials the Company is currently running.
1) Phase II CALM study: U.S. based 54 patient
intratumoural late stage melanoma trial.
This is the first CAVATAKTM trial to
be reviewed and allowed by the U.S. FDA.
Treatment of patients with CAVATAKTM
has commenced at 2 U.S. sites. Additional
patients from further sites have consented to
join the trial and are expected to commence
CAVATAKTM treatment shortly.
Treatment consists of 10 visits where up to
8 individual tumours are injected with
CAVATAKTM at each visit.
The company currently has institutional
board approval from 4 U.S. based sites to treat
patients with CAVATAK TM with approval from
a further 2 sites expected shortly.
For further information about this trial,
please visit the Clinical Trial website using the
following link:
http://clinicaltrials.gov/ct2/show/NCT01227551
The U.S. based Phase II trial was commenced
following the completion of 2 Australian-based
Phase I trials of intratumoural administration of
CAVATAKTM in late stage melanoma
patients.
2) Phase I intravenous late stage Melanoma,
Prostate, Breast and Co-rectal cancer trial:
Australian based, 9 patient trial.
Intravenous delivery of CAVATAKTM is
an important strategic aim of the Company. The
ability to deliver CAVATAKTM intravenously
will potentially allow the treatment of a greater
range of cancers.
In this Phase I study, 8 of 9 patients have
been infused with CAVATAKTM and have
completed the trial. The 9th and last patient is
expected to enter the trial in early February.
The primary objective of this study is patient
safety. This trial is a crucial precursor to
commencing a Phase II intravenous trial of
CAVATAKTM . Strategic planning for the
intravenous Phase II trial protocol
and primary endpoint has commenced. To date,
intravenous infusion of CAVATAKTM has been well
tolerated.
3)Phase I intratumoral late stage Head and Neck
cancer trial: Australian based, 9 patient
trial.
This Phase I trial was designed to be a
multi-dose, multi-injection safety study.
Currently, 3 patients have been treated with
CAVATAKTM in this study. The clinical
objectives this trial was going to generate have
now been superseded by those contained within the
U.S. based Phase II melanoma trial discussed
above.
As a result, a decision has been made to
close this trial and direct the Company's
resources to its CAVATAKTM Phase II
clinical development program.
Viralytics' clinical development program is
now clearly focused on its Phase II evaluation of
CAVATAKTM in both intratumoral and
intravenous settings, allowing investigation of
both direct cancer cell oncolysis and development
of anti-tumour immune responses.
Enquiries
Bryan Dulhunty
Viralytics Ltd
T: 02 9988 4000
W: www.viralytics.com
About Viralytics Ltd: Viralytics is listed
on the Australian Stock Exchange (ASX code: VLA),
Viralytics ADR trades under VRACY on the OTC
market in the USA. Viralytics' principal
asset is the intellectual property relating to
CAVATAK™, an Oncolytic Virus technology.
CAVATAK™is the trade name for Viralytics'
proprietary formulation of the Coxsackievirus
Type A21 (CVA21). EVATAK™is the trade name for
Viralytics' proprietary formulation of the
Echovirus Type 1 (EV1). CVA21 and EV1 are viruses
that occur naturally in the community. CVA21 and
EV1 attach to the outside of cells, using a
specific 'receptor' on the cell's
surface (like a key fitting a lock). CVA21 uses
the receptors, intercellular adhesion molecule-1
(ICAM-1) and/or decay accelerating factor (DAF)
to bind and infect target cells. Both of these
receptor proteins have been demonstrated to be
highly expressed on multiple cancer types,
including: melanoma, prostate cancer, breast
cancer, multiple myeloma and others. EV1 uses the
receptor, integrin
VIRALYTICS LTD. 
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