05:12:41 EDT Tue 09 Jun 2026
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Adherex Technologies Inc (3)
Symbol AHX
Shares Issued 25,157,861
Close 2013-05-23 C$ 1.06
Market Cap C$ 26,667,333
Recent Sedar+ Documents

Adherex told by FDA, consider larger eniluracil trials

2013-05-23 21:20 ET - News Release

Mr. Rosty Raykov reports

ADHEREX REPORTS FEEDBACK FROM THE FDA FROM END OF PHASE 2 MEETING

Adherex Technologies Inc. has received feedback from the U.S. Food and Drug Administration at an end-of-phase-2 meeting held yesterday. During the FDA meeting, Adherex reviewed the opportunity that eniluracil offers to metastatic breast cancer patients who had rapid disease progression on capecitabine. Adherex proposed a small pivotal single-arm clinical study addressing the special ability of eniluracil/5-FU/leucovorin to meet the medical needs of these patients. However, the agency strongly recommended that Adherex consider other larger clinical trial design alternatives for the future development of eniluracil in MBC. In light of the company's limited resources, Adherex is taking the agency's recommendations into consideration as it reviews the feasibility of these and other clinical options.

The children oncology group phase 3 trial evaluating sodium thiosulphate as an otoprotectant after cisplatin exposure completed enrolment of 135 children in 2012. Results from the phase 3 trial conducted by the children oncology group are expected during the second or third quarter of 2013.

We seek Safe Harbor.

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