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Aeterna Zentaris under the cosh as myeloma candidate fails

Phase III trial of perifosine halted after poor results

Canadian drug development company Aeterna Zentaris has halted a phase III trial of its multiple myeloma candidate perifosine after an interim analysis suggested it was ineffective.

Shares in the pharma company plummeted after it announced that the study's data and safety monitoring board concluded that perifosine was no better than placebo in extending progression-free survival (PFS), although no safety concerns were raised.

The trial involved patients with relapsed or relapsed/refractory multiple myeloma who were also being treated with Takeda's Velcade (bortezomib) and dexamethasone.

Aeterna Zentaris said the negative trial result meant that it will drop development of perifosine in myeloma.

This is a second major blow for Aeterna Zentaris' aspirations for perifosine. Last year, the company reported that perifosine given in combination with Roche's Xeloda (capecitabine) failed to significantly improve overall survival compared to placebo in a phase III trial of patients with advanced colorectal cancer.

That result prompted the US developer of the drug, Keryx Biopharmaceuticals, to return rights to Aeterna Zentaris, which is also exploring the activity of perifosine in renal cell carcinoma, non-small cell lung cancer (NSCLC), breast cancer and sarcoma.

Perifosine rights have also been licensed to Yakult Honsha for Japan, Handok for Korea and Hikma for the Middle East and North Africa.

Perifosine is currently the furthest ahead in development among a new class of orally-active cancer drugs known as AKT inhibitors.

The drug class also includes a phase I candidate from GlaxoSmithKline called GSK1120212 that is being tested in multiple myeloma and Merck & Co's MK-2206, which has reached phase II in gastric and prostate cancer.

"We are obviously disappointed with the outcome of the interim analysis as reported to us by the DSMB, both from a patient and company perspective," said Aeterna Zentaris' chief executive Juergen Engel. 

"However, we remain focused on other significant opportunities such as our phase III trial in endometrial cancer and phase 2 trials in breast, prostate and bladder cancer with AEZS-108," he added.

AEZS-108 is a doxorubicin peptide conjugate which achieved a 31 per cent objective response rate in a phase II trial in endometrial cancer. Meanwhile, Aeterna Zentaris has also filed for approval in the US for an oral diagnostic test for growth hormone deficiency in adults, and has an earlier-stage oncology candidate - AEZS-120 vaccine for prostate cancer - nearing the clinic.

13th March 2013

From: Research



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