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Biotech / Medical : Micromet Inc (MITI) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (39)	8/3/2006 4:04:33 PM
From: tuck	Read Replies (2) \| Respond to of 196

Well, I can't find diddly on trial design in the PRs, which are exceptionally light on detail. >>March 9th, 2004 Micromet Starts Phase II Trial in Breast Cancer with Fully Human Antibody MT201 MT201 to offer biological treatment to new segment of breast cancer patients Munich, Germany -- Micromet AG has initiated a randomized, open-label, international, phase II trial to investigate the efficacy and safety of MT201 for the treatment of breast cancer patients who experienced a metastatic relapse. The trial will evaluate the clinical response to two different dose levels of MT201 in two parallel treatment groups. The study is being conducted at multiple sites in Europe and will enroll approximately 100 patients. Breast cancer is the second indication after prostate cancer that is being evaluated in the context of Micromet’s phase II program on MT201. Breast cancer is the most common cancer in the world. Notwithstanding substantial progress in therapeutic treatment, there remains a large unmet medical need, in particular when the tumor has spread throughout the body and invaded distant organs. Standard treatment for these patients consists of chemotherapy, hormonal treatment and radiation, all of which have limited efficacy and cause unfavorable side effects. In contrast to these treatments, MT201 works by specifically targeting cancer cells and mediates tumor cell destruction by utilizing the body’s own immune defense. Phase I data have demonstrated an excellent safety profile for the compound. “For many breast cancer patients, MT201 may provide a safe and effective alternative or complement to chemotherapy. Moreover, it may considerably expand the group of patients who have access to targeted biological therapy,” Erich Felber, CEO of Micromet said. At present, less than 20% of all breast cancer patients are eligible for treatment with the humanized antibody Herceptin®, the only biological therapy approved so far for the treatment of breast cancer. While Herceptin® targets the HER2 antigen, Micromet’s fully human antibody MT201 recognizes the Ep-CAM antigen, a surface molecule which is broadly and highly expressed in many tumors. In breast cancer, Ep-CAM expression on tumors is found with 90% of patients. About 40% show a significant overexpression of Ep-CAM on their tumors. Ep-CAM is also present in tumors of the prostate, colon, lung, breast, stomach, pancreas, head & neck and ovary, suggesting that MT201 has the potential to improve the treatment of a wide range of solid tumors.<< The PR announcing the beginning of the prostate trial is similarly uninformative. One has to dig into the 425s to find the goods. I'll paste what I found, because they are big suckers due to high graphics content (it's all in slide form). If you don't have good broadband, I suggest you take my word that I copied the following slide accurately: PII Metastatic Breast Cancer: "Enrolment completed; 112 patients, 26 sites, 5 EU countries. Prelimanary analysis of interim data show significant increase in progression-free survival for high dose/high Ep-Cam group relative to three other groups (p=0.0238)" PII Early Prostate Cancer "Enrolment Completed; 84 patients, 20 sites, 4 EU countries. Preliminary data indicate that the primary endpoint has not been reached; no obvious change in PSA vs. placebo." sec.gov So I see Loonie Bros. pessimism now. Prostate trial is not going well at all. In the breast cancer trial, we do not know the patient population, and there is a subset analysis, one of four groups. They used up some p value to get this iffy look. What kind of power do they have? We don't know the numbers in the groups. Reasonable likelihood that the subset analysis is noise. So I have to believe Doc Praveen saw all this and is looking beyond MT-201. Certainly, I'd be on the sidelines until MT-201 data due later this year is out. I doubt that the PI data from MT-103 will make up for it, should it come out first. MT-103 may be a fine molecule, but I'd want to get the clinical risk from MT-201 out of the way first before investing here. Caveat, I don't know much about the company, and I may be missing other drivers. Cheers, Tuck