TIDMSAR
RNS Number : 1628H
Sareum Holdings PLC
05 June 2017
(AIM: SAR) 5 June 2017
SAREUM HOLDINGS PLC
("Sareum" or "the Company")
Chk1 Clinical Trials Update
Sierra Oncology Reports Encouraging Initial Progress from
Ongoing Phase 1 Clinical Trials
Sareum Holdings plc (AIM:SAR), the specialist cancer drug
discovery and development company, notes an announcement made today
by Sierra Oncology, Inc. reporting on the initial progress of the
two ongoing Phase 1 trials of the Chk1 inhibitor, SRA737. The full
announcement can be found on Sierra Oncology's IR website(*) .
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014.
The SRA737 Phase 1 monotherapy trial has advanced through six
single patient dose cohorts of 20, 40, 80, 160, 300 and 600 mg/day,
administered under a continuous daily oral dosing regimen in 28-day
cycles. Dose escalation will continue until a maximum tolerated
dose (MTD) is reached, in parallel with ongoing Cohort Expansion
enrolment.
Preliminary observations from the ongoing monotherapy study are
as follows:
-- SRA737 has been very well-tolerated to date: No Grade 2 or
higher SRA737-related adverse events have been reported. No
dose-limiting toxicities have been observed and an MTD has not been
reached.
-- Dose-proportional exposure: Pharmacokinetic (PK) parameters
for SRA737 have been generally linear across the dose range tested
to date.
-- Plasma concentrations of SRA737 exceeding the proposed
minimum efficacious threshold (Cmin) of 100 nM were maintained for
24 hours post-dose at the 160 mg/day dose level and above.
Having successfully surpassed the proposed minimum efficacious
exposure threshold, the Cohort Expansion Phase of the trial has
commenced and is enrolling patients with tumours identified to have
genetic aberrations hypothesized to confer sensitivity to Chk1
inhibition via synthetic lethality into five indication-specific
cohorts: colorectal, head and neck, non-small cell lung, ovarian,
and prostate cancers.
For the Phase 1 Chemotherapy Combination study, Stage 1, which
is evaluating SRA737 in combination with gemcitabine and cisplatin,
has concluded enrolment and the study has transitioned to Stage 2.
This stage is seeking to establish the safety profile, determine
the MTD and propose a recommended dose for further development of
SRA737 in combination with low-dose gemcitabine. Once an MTD and
dosing schedule have been determined, the study will also evaluate
the preliminary efficacy of SRA737 in combination with low-dose
gemcitabine in indication-specific cohorts of
prospectively-selected, genetically-defined subjects with bladder
or pancreatic cancer.
Gemcitabine is a potent inducer of replication stress and DNA
damage via multiple mechanisms, and represents a rational drug
combination for SRA737, given Chk1's fundamental biological role in
responding to such stressors. The preclinical modelling
demonstrates robust synergistic anti-tumour activity of SRA737 in
combination with low-dose gemcitabine.
Dr Tim Mitchell, CEO of Sareum, commented: "We are very pleased
with the amount of progress that has been made in both clinical
trials of SRA737 and that the trial data is consistent with
preclinical studies. In particular we are pleased to note that
SRA737 has been very well tolerated in the monotherapy trial and
that there have been no dose limiting toxicities observed so
far.
"We look forward to the next update from these studies, which
Sierra has indicated could potentially include preliminary activity
data, in early 2018."
Sierra Oncology holds exclusive and worldwide rights for the
Chk1 inhibitor, SRA737, having licensed the programme from Sareum's
co-investment partner, the CRT Pioneer Fund in September 2016. This
announcement does not trigger any milestone payments under the
terms of the agreement.
As previously announced, Sierra is today presenting two posters
describing the innovative designs of these clinical trials at the
2017 American Society of Clinical Oncology (ASCO) Annual Meeting,
being held in Chicago. Copies of the posters are available on
Sierra's website at www.sierraoncology.com.
*http://investor.sierraoncology.com/2017-06-05-Sierra-Oncology-Reports-Encouraging-Initial-Progress-from-Ongoing-Phase-1-Clinical-Trials-of-Chk1-Inhibitor-SRA737
For further information, please contact:
Sareum Holdings plc
Tim Mitchell 01223 497 700
WH Ireland Limited (Nominated Adviser and
Co-Broker)
Chris Fielding / Nick Prowting 020 7220 1666
Hybridan LLP (Co-Broker)
Claire Noyce 020 3764 2341
The Communications Portfolio
(Sareum Media enquiries)
Ariane Comstive
Ariane.comstive@communications-portfolio.co.uk 07785 922 354
Notes for editors:
Sareum is a drug discovery and development company delivering
targeted small molecule therapeutics, focusing on cancer and
autoimmune disease, and licensing them to pharmaceutical and
biotechnology companies at the preclinical or early clinical trials
stage.
Sareum operates an outsourced research model, working with
international collaborators and a world-wide network of research
providers. Its most advanced programme (Chk1) commenced clinical
trials in May 2016 and was licensed to NASDAQ-listed Sierra
Oncology in September 2016.
SKIL(R) (Sareum Kinase Inhibitor Library) is Sareum's drug
discovery technology platform that has so far produced the
Company's Aurora+FLT3 and TYK2 kinase cancer and autoimmune disease
research programmes, which are in the IND-enabling preclinical and
lead optimisation stages respectively. SKIL(R) can also generate
drug research programmes against other kinase targets.
Sareum Holdings plc is listed on the AIM market of the London
Stock Exchange, trading under the symbol SAR. For further
information, please visit www.sareum.co.uk
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
END
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