Cortendo AB (OSE:CORT) today announced that the first patient has been
enrolled into the Phase 3 SONICS trial, i.e., “Study Of NormoCort In
Cushing’s Syndrome.”
The patient was enrolled by one of the trial’s lead principal
investigators at a Pituitary Center from a prestigious institution in
Baltimore, Maryland. “The enrollment of the first patient into the
SONICS trial represents a significant milestone for Cortendo”, said Dr.
Theodore R Koziol. ”The SONICS clinical trial team is acutely focused on
the implementation of the trial following a successful EU Investigator’s
meeting in Barcelona in July, which we believe further solidified the
foundation for the trial.”
Cortendo successfully completed its European Investigator meeting
supporting SONICS held in Barcelona, Spain on July 17-18. More than 35
investigators/study coordinators, including many of the world’s leading
Cushing’s experts from 24 study sites, were in attendance and received
training for the trial. Based on the positive feedback from the meeting,
Cortendo has gained further confidence that NormoCort (COR-003) has the
potential to be an important future treatment option for patients
afflicted with Cushing’s Syndrome. A second US Investigator meeting is
also being planned for later this year.
”It was gratifying to participate in the NormoCort SONICS trial
investigator meeting in my home town of Barcelona with so many esteemed
colleagues dedicated to treating patients with Cushing’s Syndrome”, said
Susan Webb M.D. Ph.D. Professor of Medicine Universitat Autonoma de
Barcelona. ”There remains a significant unmet medical need for patients,
and I am delighted to be part of the development of this new therapy”.
Cortendo has also further strengthened its internal as well as external
teams to support the study and to position the trial for an increased
recruitment rate. In July, Cortendo added both an experienced physician
and internal Clinical Operations Director to the NormoCort development
team. Cortendo, working in concert with its CROs supporting the SONICS
trial, now has a team of approximately 20 personnel on the NormoCort
development program.
Cortendo has previously communicated its plan to meet the recruitment
goal by increasing the number of study sites from 38 to 45 worldwide.
The company is at various levels of activation with more than 30 study
sites to date. Therein, Cortendo expects a large proportion of the sites
to be activated by the end of the third quarter this year and remains
confident that essentially all sites will be open by the end of 2014.
Risk and uncertainty
The development of pharmaceuticals carries significant risk. Failure may
occur at any stage during development and commercialization due to
safety or clinical efficacy issues. Delays may occur due to requirements
from regulatory authorities not anticipated by the company.
About Cortendo
Cortendo AB is a biopharmaceutical company headquartered in Göteborg,
Sweden. Its stock is publicly traded on the NOTC-A-list (OTC) in Norway.
Cortendo is a pioneer in the field of cortisol inhibition and has
completed early clinical trials in patients with Type 2 diabetes. The
lead drug candidate NormoCort, the 2S, 4R-enantiomer of ketoconazole,
has been re-focused to Cushing’s Syndrome, and has entered Phase 3
development. The company’s strategy is to primarily focus its resources
within orphan drugs and metabolic diseases and to seek opportunities
where the path to commercialization or partnership is clear and
relatively near-term. Cortendo’s business model is to commercialize
orphan and specialist product opportunities in key markets, and to
partner non-specialist product opportunities such as diabetes at
relevant development stages.
Cortendo Forward-looking Statements
This press release contains forward-looking statements concerning
Cortendo that involve a number of risks and uncertainties. All
statements other than statements of historical facts included in this
press release, including, without limitation, statements regarding the
Company’s future financial position, strategy, anticipated investments,
costs and results, plans, projects to enhance efficiency, outcomes of
products development, future capital expenditures, liquidity
requirements and objectives of management for future operations, may be
deemed to be forward looking statements. These forward looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the Company’s actual results, performance or
achievements or industry results to be materially different from those
contemplated, projected, forecasted, estimated or budgeted, whether
expressed or implied, by these forward looking statements. Given these
risks and uncertainties, investors should not place any undue reliance
on forward looking statements as a prediction of actual results. None of
these forward looking statements constitutes a guarantee of the future
occurrence of such facts and data or of actual results. These statements
are based on data, assumptions and estimates that the Company believes
are reasonable. The forward looking statements contained in this
document are made only as of the date hereof. The Company expressly
disclaims any obligation or undertaking to release publicly any updates
of any forward-looking statements contained in this press release to
reflect any change in its actual results, assumptions, expectations or
any change in events, factors, conditions or circumstances on which any
forward looking statement contained in this press release is based.
Cortendo AB (publ)
Sweden: Box 47 SE-433 21 Partille Tel. / Fax: +46 (0)31-263010
USA: 555 East Lancaster Ave Suite 510 Radnor, PA 19087
Tel: +1 610-254-9200 Fax: +1 610-254-9245
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