MITI Presents Positive Data at ASH - Analyst Blog

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Recently, biopharmaceutical company, Micromet Inc. (MITI) presented updated durability data from a phase II study of its blood cancer pipeline drug blinatumomab (MT103) at the annual meeting of the American Society of Hematology (ASH).

The phase II study was evaluating the safety and efficacy of blinatumomab in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL), a type of blood cancer. The data showed that binatumomab prolonged remissions in patients with ALL.

All 21 patients in the study have seen three or more prior cycles of chemotherapy regimens.  Out of the 20 evaluable patients in the study, 80% achieved the primary endpoint of molecular complete response after the first 28 days of treatment.

The updated durability data showed that median disease free survival (DFS) is 60% with follow up of up to 27.5 months. Further, it should be noted that there has been no hematological relapses since the ASH 2009 presentation.

At the same meeting, the company also presented data from phase I trial studying blinatumomab in patients with relapsed non-Hodgkin's lymphoma (NHL). It was observed that blinatumomab produced a high objective response rate in heavily pretreated (particularly with Rituxan) NHL patients. The drug also produced high response rate and duration of response in a number of different NHL subtypes like mantle cell lymphoma (MCL).

Recently, Micromet commenced the European pivotal trial (BLAST) with the candidate in patients with MRD-positive ALL. The trial is now enrolling at up to 70 leading cancer centers in Europe and the US. In addition, the company is also conducting a phase II trial intended to establish blinatumomab's activity in adult patients with more advanced ALL.  Data from the trial is expected in 2011.

The company plans to initiate three additional blinatumomab trials in 2011. These include a phase I/II trial in relapsed refractory pediatric ALL patients, phase II trial of blinatumomab in patients with chronic lymphocytic leukemia (CLL) and a phase II trial in patients with MCL.

Blinatumomab is the most promising candidate at Micromet. The company reacquired the rights of blinatumomab from AstraZeneca (AZN) recently, following which Micromet now controls global rights to develop and commercialize blinatumomab.

Our Take & Recommendation

Currently, we have a Neutral recommendation on Micromet. The company is progressing well with its pipeline candidates, as seen in the positive ALL and NHL data for its blinatumomab drug.

Another pipeline drug at the company is MT111, which is currently in an early stage of development. Though we believe Micromet's association with large pharma players will help ease its way through the development phase, the early stage status of the pipeline worries us.

Moreover, the excessive dependence on blinatumomab is also a concern as any hiccup in its clinical development programs will weigh heavily on the stock.


 
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