Alchemia shares sink on negative trial result

Shares in Alchemia (ASX:ACL) fell more than 80% after the company revealed its phase III trial of HA-Irenotecan in metastatic colorectal cancer did not meet its primary end point.

The phase III trial failed to achieve the end point of a statistically significant improvement in progression-free survival (PFS) when using HA-Irinotecan over Irinotecan.

Patients received either Irinotecan or Alchemia’s formulation as part of the conventional FOLFIRI treatment regimen.

Both treatment groups demonstrated a median PFS of 5.5 months, and both groups demonstrated an equivalent overall survival of 14 months.

“We are extremely disappointed in the outcome of this trial,” Alchemia CEO Thomas Liqard said. “We will undertake further analysis [and] expect to report back to the scientific community and the market with further details on our data, reviews and corporate strategy early in 2015.”

Alchemia chief science officer Dr Tracey Brown said the problem with the trial was that the median PFS in the Irenotecan group was unexpectedly high, rather than the reverse. The company will conduct a detailed review of the data to try to determine why this was the case, as well as the impact of other variables.

“With these additional analyses in hand, we will be in a better position to formulate the next steps for the HA-Irinotecan development programs.”

HA-Irinotecan is also in trials in small cell lung cancer, in part to determine whether the treatment can be safely combined with carboplatin.

Alchemia (ASX:ACL) shares fell 83.06% to $0.105 after the results were announced on Monday. The shares since edged up 4.76% to $0.11 as of around 1.30 pm on Tuesday.