Funding of the Phase II study with IdeS secured
Background and motive
The successful Phase I-study with IdeS in 2013 demonstrated IdeS as safe, fast and efficient in inactivating antibodies. These characteristics are much anticipated by transplantation surgeons around the world as this has the potential to enable transplantation of thousands of patients with donor specific antibodies. The rights issue will provide means to pursue a Phase II-study starting in spring 2014 aiming to make patients with donor specific antibodies eligible for transplantation. IdeS’ Phase II-study will be performed at Uppsala University Hospital, with an anticipated duration of approximately one year. Intermediate accomplishment will be communicated to some extent during the study year. Filing of the Phase II-application with the Swedish Medical Products Agency is scheduled for the first quarter of 2014.
IdeS is an enzyme specifically inactivating IgG-antibodies. Donor-specific antibodies are of the IgG-type and Hansa Medical envisions a single dose intravenous injection of IdeS being dispensed prior to kidney transplantation in patients with donor specific antibodies. IdeS has the potential to remove the antibody barrier within minutes after dosage, hence enabling transplantation of patients today referred to long-term dialysis treatment. Long-term dialysis is costly and is associated with a significantly increased risk of death caused by stroke and/or heart disease. Approximately one third of sensitized patients decease while waiting for a transplant.
Preliminary schedule for preferential rights issue
5 March 2014 Extraordinary meeting of shareholders
17 March 2014 Publication of prospectus
18 March 2014 Last day of share trading with the right to subscribe
21 March 2014 Record day for the receipt of subscription rights
25 March– 8 April 2014 Subscription period
3 April 2014 Last day for subscription rights trading
11 April 2014 Public notice of outcome
For further information, please contact:
Emanuel Björne, CEO Hansa Medical AB
Mobile: +46 707 17 54 77
The information in this press release is such information that Hansa Medical AB (publ) is obliged to disclose under the Securities Market Act and/or the Financial Instruments Trading Act. The information was made public on February 14, 2014 at 14:00 am CET.