Adherex reports ADH-1 was well tolerated in trial, showed antitumor activity

New York, June 3 - Adherex Technologies Inc. announced data from the phase 1b part of its phase 1b/2 European study of its molecularly targeted anticancer drug, ADH-1, that showed the molecule was well tolerated and showed antitumor activity.

"ADH-1 continues to be well tolerated in our single-agent studies," said William P. Peters, Adherex's chairman and chief executive officer, in a news release.

"We have encountered no limitations in the tolerance of the drug, and it has shown additional evidence of antitumor activity in three tumor types."

Peters added that the company is now enrolling additional patients with ovarian and lung cancers using ADH-1 as a single agent at doses of 2,400 mg/m(2).

The data, presented at the annual meeting of the American Society of Clinical Oncology, covered 20 patients who received a total of 123 doses (41 cycles) of ADH-1, given on a weekly schedule with doses ranging from 150 to 2,400 mg/m(2).

ADH-1 was well tolerated in all five doses tested, displayed predictable pharmacokinetics (which is important for proper drug dosing) and demonstrated evidence of antitumor activity in three patients with advanced, therapy-resistant cancer, including one patient with an unconfirmed partial response and two with prolonged stable disease, Adherex said. A maximum tolerated dose was not defined.

The three patients in which evidence of antitumor activity was noted included a 61-year-old woman with N-cadherin positive fallopian tube carcinoma and lymph node metastases. This patient, whose antitumor activity was previously reported, achieved a 30% total reduction in her lymph node metastases at the end of cycle three, meeting the criteria for a partial response by Recist criteria, and a 37% reduction at the end of cycle four. However new bone lesions were noted at the end of cycle four, making this patient's response an unconfirmed partial response.

The second patient is a 32-year-old woman with N-cadherin positive ovarian cancer who has experienced stable disease for more than six months and continues on the study. The third patient is a 40-year-old woman with N-cadherin positive colorectal cancer who has experienced stable disease for more than three months and continues on the study.

In total, seven patients have now shown evidence of antitumor activity.

Adherex, located in Research Triangle Park, N.C., is a biopharmaceutical company focused on developing treatments for cancer.

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