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Cephalon, Celgene Kick Off Biotech Confab

Both companies reported successful findings on studies.

The American Society of Hematology kicked off its annual meeting this weekend, which means there was plenty of clinical data presented on treatments for a variety of blood cancers.






were among the biotech companies making news this weekend at the event that will run through Tuesday. Here's a rundown:

Cephalon: Treanda Beats Current CLL Drug

Cephalon's experimental cancer drug Treanda bested a currently used chemotherapy drug in putting patients with chronic lymphocytic leukemia (CLL) into remission, according to results from a late-stage study presented Sunday.

Treanda has already been submitted to the FDA for approval as a new treatment for CLL, which is a cancer that affects a type of white blood cell. Cephalon expects a decision by the end of March 2008.

In the study presented Sunday, newly diagnosed CLL patients treated with Treanda (also known as bendamustine) reported a remission rate of 68% compared to a remission rate of 39% for patients treated with chlorambucil, a chemotherapy drug currently approved as a CLL treatment. These results, the primary endpoint of the study, were highly statistically significant.

Treanda also significantly improved the time before patients' cancer progressed -- 21.7 months for Treanda compared to 9.3 months for chlorambucil.

Approximately 15,000 new cases of CLL are diagnosed in the United States every year. If approved, Treanda could become the new front-line standard of care for the disease, although the drug will face competition from other drugs, including



Rituxan, which enjoys considerable market share as a CLL treatment.

In a separate presentation, researchers also reported that Treanda was effective in treating patients with indolent non-Hodgkin's lymphoma (NHL) whose cancers progressed after treatment with Rituxan.

In a study of 100 patients whose cancer progressed after being treated with Rituxan, 75 patients had a response to Treanda. Of these patients, 14 had a complete response and three had an unconfirmed complete response, researchers reported. NHL is a cancer of the lymphatic, or immune, system.

Rituxan is the cornerstone of treatment for indolent NHL, in part because patients can be retreated with the drug once the cancer starts growing again. While patients can be retreated with Rituxan for years, the efficacy of Rituxan decreases with every retreatment, however, and the drug eventually stops working.

Cephalon plans on seeking FDA approval to market Treanda as a treatment for NHL patients refractory to Rituxan. The company says it will file an approval application before the end of the year.

Cephalon shares fell $1.01, or 1% to $76.54 a share Friday.

Celgene: Revlimid Combo Helps

The combination of Revlimid and a low dose of the steroid dexamethasone significantly prolonged survival in patients with newly diagnosed multiple myeloma, according to an update from a previously reported clinical trial reported Sunday. Multiple myeloma is a cancer of the bone marrow.

Overall survival was 96% at one year and 87% at two years for patients treated with Revlimid plus low-dose dexamethasone.

Data from this trial was first reported last year, prompting many doctors to begin using the Revlimid-dexamethasone regimen in their newly diagnosed multiple myeloma patients. Revlimid is officially approved for use in multiple myeloma patients who have failed other therapies.

Celgene shares fell $2.74, or 4.5%, to $57.36 Friday.

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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