DGAP-Adhoc
Cytos Biotechnology Ltd (SIX:CYTN) today published the topline results of the global Phase 2b clinical trial with CYT003.
Cytos Biotechnology AG / Key word(s): Research Update
14.04.2014 07:00
Release of an ad hoc announcement pursuant to Art. 53 KR
---------------------------------------------------------------------------
Cytos Biotechnology Ltd announces negative topline results of clinical
trial with CYT003
Phase 2b Study of CYT003 in moderate to severe allergic asthma misses
endpoints
Company evaluates options of ordinary winding down of operations and
liquidation
Schlieren, Switzerland - April 14, 2014 - Cytos Biotechnology AG (SIX:
CYTN) today announced that the Phase 2b study of CYT003 in patients with
moderate to severe allergic asthma did not achieve a statistically
significant reduction of the Asthma Control Questionnaire (ACQ) score at
week 12 in the target patient population compared to placebo. Patients on
placebo and at all dose levels of CYT003 achieved a clinically relevant
improvement in their asthma control measured by ACQ. Additional endpoints,
including lung function also failed to show a statistically significant
difference to placebo. The clinical study was planned to continue with a
blinded observation period of 9 months. Considering the clear outcome,
Cytos has determined to unblind and terminate the clinical study.
As a result of the failure to achieve the primary endpoint, the previously
announced condition for the conversion of convertible loan notes has not
been achieved, and the company therefore considers the prospects of raising
new funding sufficient to continue as a going concern to be remote.
Consequently, the company's board of directors has instructed management to
evaluate the options for an ordinary winding down of operations and
liquidation of the company or a possible bankruptcy. In addition, the
company has initiated the consultation process for a mass dismissal of all
of the company's 36 employees.
Dr. Christian Itin, Chairman and CEO of Cytos, commented: "We are very
disappointed with the outcome of the Phase 2b study and would like to thank
our patients and investigators for their support of the study. We would
also like to thank our employees for their outstanding effort that was
required to rebuild the company after the restructuring and mass dismissals
in 2012. When developing the plans for winding down operations, we will
seek to minimize adverse consequences for our employees and other
stakeholders."
The cash balance of the company as of March 31st, 2014 was CHF31 million.
The company does not expect to be able to repay any convertible bonds which
are all subordinated to other creditors. Likewise, the company also does
not expect to be able to pay any liquidation dividend to shareholders.
Aktuelle Themen
Weitere Artikel des Autors
1 im Artikel enthaltener WertIm Artikel enthaltene Werte