According to a press release issued by Epicept Corporation this week, new data published in the July 7, 2011 edition of Blood, a leading scientific journal in hematology, demonstrated that "interleukin-2 (IL-2) monotherapy is not effective as a maintenance therapy for acute myeloid leukemia (AML) patients in first complete remission."

This is hugely relevant news for the company, as Epicept's lead product, Ceplene, has shown in clinical studies to be effective in AML in first remission, when used in conjunction with low-dose IL-2.

According to the article, "The combined individual patient data of 1,455 patients collected over several years showed no benefit of IL-2 compared with standard of care in terms of leukemia free survival (LFS) (p=0.74) or overall survival (OS) (p=0.39)."

Ceplene is already approved in Europe, although sales are not expected to be noticeable until next year. Epicept has been in discussions with the FDA regarding the way-ahead for bringing the product to market in the US, although dealings with the FDA have not gone without bumps in the road.

The new data does have implications in Epicept's negotiations with the FDA. CEO Jack Talley had this to say in the press release:

Further, this new analysis also supports our position, endorsed by the European Medicines Agency, that because IL-2 monotherapy treatment has been shown to be ineffective, it is now unethical to offer that therapy in any subsequent clinical study."

The company is attempting to arrange a follow-up meeting with the FDA.

As the Ceplene story plays out in the US and sales look to increase in Europe, Epciept has also made progress with AmiKet (formerly known as NP-1), a topical cream for pain which the company is looking to partner.

Crolibulin, a cancer treatment for which the National Cancer Institute recently initiated a trial, may hold the most potential in the pipeline, along with Azixa, a brain cancer treatment partnered with Myrexis.

The financing of this company is always what holds the most concern, and it's likely that another reverse split is in store, but the long term potential of EPCT remains.

Given the length of time it took to sign a Ceplene partner, it would be a significant event - and one that would boost investor confidence in management - if an AmiKet partner came sooner, rather than later.

For fifty cents? Worth the speculative 'ADD', in my book.

Disclosure: Long EPCT.

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