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Phase 3 Trial Of Perifosine In Myeloma Is Halted

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Published: Mar 11, 2013 5:25 pm; Updated: Mar 12, 2013 9:35 am

Aeterna Zentaris (NASDAQ:AEZS) announced today that the Canadian company is discontinuing its Phase 3 clinical trial of perifosine for the treatment of relapsed and refractory multiple myeloma.

An independent Data Safety Monitoring Board recommended the trial be discontinued after interim results showed that perifosine (KRX-0401) plus Velcade (bortezomib) and dexamethasone (Decadron) has not, and most likely will not, significantly extend progression-free survival com­pared to Velcade and dexamethasone alone.

The Board did not raise any safety concerns related to perifosine.

Aeterna Zentaris did not explicitly state in its announcement today that it is halting all further development of perifosine as a myeloma treatment.  However, it would not be surprising if that is, in fact, the end result of today's news.

(Update, March 12, 2013 - A representative from Aeterna Zentaris has confirmed to The Beacon that the company does not intend to pursue any further development of perifosine as a myeloma treatment.)

Had the perifosine clinical trial been successful, the drug could have become the next novel anti-myeloma therapy approved by the U.S. Food and Drug Administration (FDA).

Today’s development, however, means that it most likely will be at least two more years until a new myeloma drug is approved by the FDA.

Perifosine (KRX-0401) is an orally administered drug that belongs to a new class of anti-cancer drugs known as “Akt-inhibitors.” Akt is a protein believed to play an important role in the development and growth of cancer cells.

GlaxoSmithKline (NYSE:GSK) is currently testing another Akt inhibitor, known by the codename GSK1120212, in combination with Velcade and dexamethasone in a Phase 1b trial involving relapsed myeloma patients.

Initially, perifosine was investigated as a potential treatment for colon cancer.  However, the drug failed last year to show a statistically significant survival benefit in a Phase 3 clinical trial in colon cancer.

This news led the company that was developing perifosine for the North American market, Keryx Bio­phar­ma­ceut­i­cals (NASDAQ:KERX), to halt further investment in the drug and return development rights to Aeterna Zentaris.

Aeterna Zentaris, in turn, decided to halt further development of the drug as a colon cancer treatment.

However, at the same time, the company said it would continue testing perifosine as a potential anti-myeloma therapy (see related Beacon news).

The company also announced last year that a partner company, Yakult Honsha, would begin a Phase 1 trial of perifosine for myeloma in Japan (see related Beacon news).

A representative of Aeterna Zentaris today informed The Beacon that the company is still discussing further development of perifosine with its Japanese partners.

Aeterna Zentaris's stock dropped more than 20 percent today after the company announced the discontinuation of the perifosine clinical trial.

For more information, see the Aeterna Zentaris press release.

Photo by JasonRogersFooDogGiraffeBee on Flickr – some rights reserved.
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2 Comments »

  • Myeloma Beacon Staff said:

    We've updated this article with feedback we received this morning from a representative of Aeterna Zentaris. The representative confirmed the Beacon's suspicion that the recent perifosine news means the company will not be pursuing any further development of perifosine as a myeloma treatment.

  • nancy shamanna said:

    i am sorry to hear that the phase 3 clinical trial of perifosine did not work out. it would be nice to have a completely type of myeloma drug available. if I remember correctly, an AKT inhibitor disrupts the spindle,fibers at the time of mitosis in the dividing cell.