OncoEthix Doses First Patient in its Phase I Trial of OTX015, a BET Bromodomain Inhibitor for the Treatment of Hematologic

  OncoEthix Doses First Patient in its Phase I Trial of OTX015, a BET
  Bromodomain Inhibitor for the Treatment of Hematologic Malignancies

Business Wire

LAUSANNE, Switzerland -- January 31, 2013

OncoEthix, the Swiss-based specialist in oncology drug development, announces
progress in its Phase I study of OTX015, a novel BET bromodomain inhibitor,
with the first dosing of a patient. OTX015 is a synthetic orally administered
small molecule which targets BET bromodomain proteins 2/3/4, which are
considered potential cancer targets because of their pivotal role in
regulating the transcription of growth-promoting and cell cycle regulators,
especially c-MYC. Phase I trials of OTX015 in healthy volunteers have already
been completed.

The design of the Phase I trial will seek to determine the optimum dosing
regimen for OTX015, and to provide further safety, pharmacokinetic and
pharmacodynamic data. The study will be conducted in two parts: dose
escalation, followed by expansion cohorts. In the first part, dose escalation
and determination of the recommended dose will be performed independently in
two parallel subsets of patients: patients with acute leukemia and patients
with other hematologic malignancies. Once the optimum dosing regimen has been
determined, the second part of the study will further assess safety,
pharmacokinetics, pharmacodynamics and clinical activity in disease specific
cohorts of at least 12 patients treated at the recommended dose. Study centers
are now open at five reference sites in Europe [France, Italy and Switzerland]
selected for investigators having extensive hematology and clinical
pharmacology expertise.

Bertrand Damour, CEO of OncoEthix, said “We believe that OTX015 has the
potential to be an important new drug in the continuing battle to improve and
extend the lives of patients with cancer.”

Patrice Herait, CMO of OncoEthix, said: “This multi-center study is a critical
step in determining an active dose of OTX15 and providing the necessary safety
data, as well as detecting clues of clinical activity to support further
progression through the development process.”

Preclinical data have shown that OTX015 treatment of acute leukemia (both cell
lines and patients’ cells), various subtypes of lymphoma and multiple myeloma
cell lines induces potent anti-proliferative effects associated with cell
cycle arrest, cellular senescence or apoptosis.

Oncoethix in-licensed OTX015 from Mitsubishi Tanabe Pharma Corporation in
March 2012 following completion of Phase I clinical studies in healthy
volunteers.

About OncoEthix

OncoEthix is a privately held biotechnology company that develops a small
portfolio of oncology drug candidates, ensuring a proper foundation for
commercial success. The company’s lead product, OTX008, a synthetic small
molecule targeted to galectin-1, entered Phase 1 clinical trial in January
2012. OncoEthix completed two financing rounds led by Index Ventures and
Endeavour Vision in August 2009 and in May 2012.

For more information please see: www.oncoethix.com

Contact:

At the company:
OncoEthix
Bertrand Damour, CEO
e: bertrand.damour@oncoethix.com
or
For media enquiries:
College Hill Life Sciences
Sue Charles/Katherine Granger
t: +44-(0)20-7866-7855
e: oncoethix@collegehill.com
 
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