ann: positive interim data from can-003 trial, page-2

This summary indicates encouraging trends that CVac may improve the median time to progression for patients

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RESULTS - Safety Progression Free Survival

The interim progression data of 63 patients in CAN-003 is shown as the number of days on study; patients may have either progressed or were still on study as of 17 August 2012.

The first seven patients were not randomized and treated with CVac. The next 56 patients were randomized to either CVac or OSC.

Of the 42 patients in first remission, the median progression free survival (PFS) time was 326 days for CVac and was not yet defined days for the OSC group (as fewer than half of the patients had progressed).

The non randomized first 7 CVac subjects showed a median PFS time
of 421 days. The median PFS in days for patients in second remission has not been reached for CVac , whereas OSC group shows a median of 145 days on study.

Combining overall data of first and second remission, the median PFS days on study as of date of data cut off is 365 days for CVac, 421 day for non-randomized CVac, and 321 63 patients were enrolled; 42 patients in first remission and 21 in second remission. Median age was 55 yrs (range 34-75 yrs).

83% of patients in the CVac group and 74% in the OSC group reported at least 1 treatment emergent AE.

Seven serious adverse events (SAE) have occurred; all but one were considered non related to treatment.

Five SAE in the CVac arm included two disease progression, abdominal pain, small bowel obstruction and febrile neutropenia .

Two SAE occurred in the SOC arm (abdominal pain, and hematoma/respiratory failure leading to death).

In the table of overall TEAE , 7 severe TEAE were noted (bunion, headache,
cough, itch , flu-like symptoms and urinary tract infection).days for OSC.

Second Remission

CONCLUSION
These interim data support the continued clinical development of CVac. As compared to observational standard of care, CVac is very well tolerated.

This summary indicates encouraging trends that CVac may improve the median time to progression for patients. In the first three treated patients for which immune monitoring was performed, there were good signals that CVac induced a mucin 1-specific TH1 and cytotoxic type T-cell response.

Further work is ongoing to assess immune responses of all study
patients for a longer duration and to evaluate progression free and overall survival.

Immune Monitoring : T cell mucin 1-specific responses
Analysis of three patients after the first three doses of CVac has shown a mucin 1-specific T cell response while no response was observed in normal healthy volunteers nor untreated patients . "