We presented data at ASH 2006 from Phase 1b clinical trial of tanespimycin plus Velcade in patients with highly refractory
relapsed multiple myeloma. This population had a mean of four prior regimens, and over half had been transplanted. Many of
these patients had extramedullary disease -- that is, disease outside the bone marrow -- which indicates a poor prognosis.
When we looked at response rates and stratified for Velcade status in those patients who received at least 1.0 mg/m2 of Velcade, more than 60% of patients who were Velcade-naïve responded, half the patients who were Velcade-pretreated responded and two-thirds of the patients who were Velcade-refractory responded. By way of reference, remember that in the SUMMIT Velcade trial, in Velcade-naïve patients, a 35% response rate was achieved.
Tanespimycin was very well tolerated. Toxicities were mainly GI and fatigue and were manageable and reversible. Interestingly, in this trial, we saw a very low rate of peripheral neuropathy, a side effect commonly associated with Velcade. Hsp90 inhibition may provide a neuroprotective effect, which could be of benefit in this drug combination.
We are on track to initiate a pivotal registration program around the end of the first quarter of 2007. We are naming our program Tanespimycin in Myeloma Evaluation, or the TIME program. The TIME program will include two trials. TIME-1, a Phase 3 trial, will test tanespimycin plus Velcade compared to Velcade alone in a first-relapsed setting. TIME-2, a Phase 2/3 companion trial, will test tanespimycin at various dose levels plus Velcade in a relapsed/refractory setting.
Both of these trials are anticipated to begin in the first half of 2007. We anticipate that the total number of patients we will enroll in the TIME program will be less than 600, and that the endpoint will be time to progression. If all goes according to plan, we could potentially file an NDA in 2009, with the potential for accelerated approval. As we have reported before, we have been granted orphan drug designation for tanespimycin in multiple myeloma in both the U.S. and Europe.
[From Kosan's 4th qtr CC. If these results can be repeated/confirmed, MLNM should think really hard about buying Kosan. Current market cap is "only" 185 mUSD] |
