Trials to Continue on Promising Drug for some Lymphoma Patients

An important clinical trial for patients with relapsed or refractory Hodgkin lymphoma who have previously been given autologous stem cell transplants is scheduled to begin in early 2009 under the auspices of Seattle Genetics (www.seagen.com). They will enroll 100 patients in the US, Canada and Europe.

The trial will test the efficacy of a drug currently called SGN-35, an antibody-drug conjugate (ADC) that, once it gets inside CD30-expressing tumor cells, releases monomethyl auristatin E (MMAE), which kills those cells.

They also plan to begin a phase II study of SGN-35 in early 2009 for patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

The President and CEO of Seattle Genetics told therapeuticsdaily.com, “The data thus far from both of our phase I trials of SGN-35 have exceeded our expectations … suggesting that this agent may address a substantial unmet medical need in patients with relapsed or refractory Hodgkin lymphoma.”

Provided the trials go well, Seattle Genetics intends to submit an accelerated new drug application to the FDA for SGN-35 in 2011.

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