>> It sounds too good to be true. Is it? <<
Don't think so. Guidance on potential royalty is "nice". Looks like VRTX gets to build a second company around this deal, if you like.
Switching subjects.....
biz.yahoo.com
Product Pipeline Update - Interim data have now been obtained from more than half of the patients enrolled in the XR9576/doxorubicin Phase IIa study, which is being carried out primarily to assess the degree of drug interaction, if any, between multi-drug resistance modulator XR9576 and the cytotoxic agent, doxorubicin. This trial is one of three underway with XR9576 in cancer patients, with XR9576 administered in conjunction with paclitaxel, doxorubicin and vinorelbine respectively.
Patients in the XR9576/doxorubicin trial received doxorubicin at the standard dose of 50 mg/m(2), with a single intravenous dose of XR9576 of 150 mg. The combination was well tolerated and no clinically significant PK interaction has been observed from the data to date. Recruitment is expected to be completed on schedule. The interim data from this study are similar to those from earlier findings of the XR9576/paclitaxel study, which showed no significant PK interaction between paclitaxel and XR9576 in plasma.
Although primarily designed as a PK interaction study, early indications from the paclitaxel trial in ovarian patients, which was carried out at The Royal Surrey Hospital, Guildford, UK, indicate that the response rate to date has been greater than might have been expected from patients administered paclitaxel alone. Measurement was based on an analysis of radiological, clinical and biochemical responses from the patients in this study.
The Phase IIa clinical trial involving XR9576 with vinorelbine is progressing. Data from several of the patients enrolled in the XR9576 study in the USA with vinorelbine, who have received a medical imaging agent, sestamibi, with and without XR9576, have shown that administration of a single iv infusion of XR9576 results in substantial accumulation of sestamibi in the liver for periods of up to 48 hours. In comparison, patients receiving sestamibi without XR9576 show the sestamibi to be largely eliminated from the liver in three hours. These results indicate that XR9576 may be capable of prolonged inhibition of P-gp in the liver, for up to 48 hours from a single administration. Prolonged inhibition of P-gp by XR9576 is potentially advantageous in the future treatment of patients, when compared with other P-gp inhibitors in development whose period of P-gp inhibition may be significantly shorter. |