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By measuring biomarkers in blood and lung, we can more precisely gauge the dose level of CTX-4430 required for therapeutic effect.
Satisfactory results from the previous two dose levels and the rapid advancement to the highest dose level is a further indication that PLX-PAD is a safe and potentially efficacious treatment for CLI," said Professor Doctor Hans-Dieter Volk, chairman of the Institute for Medical Immunology and the Berlin-Brandenburg Center for Regenerative Therapy (BCRT) and the head of the immunology advisory board of the study.
In a preliminary analysis at week 11, a response rate of 52% (12 of 23 evaluable patients) was observed in patients treated at the highest dose level (2000 mg).
Interestingly, the dose levels used by Galve-Roperh et al.
The agency's options include prohibiting the herb's use as a diet supplement or finding some safe or acceptable dose level that would allow it to stay on the market, he said.
04 mg/kg dose level showed a maximum reduction in viral load of 1 log10 or greater at any time during the treatment period
The trial is currently accruing to dose level 5 (115 mg) after 2 dose-limiting toxicities ("DLT") in the dose level 7 (1700x20mg) and dose level 6 (170 mg) expansion cohorts.
The advancement to the next dose level with Pluristem's placenta derived PLX-PAD is encouraging and we hope that the positive trend in clinical results derived from treating the first patients at the lower dose will continue," said Professor Dr.
The present study confirms the overall safety of Rexin-G, and further demonstrates that Rexin-G monotherapy, at these defined dose levels, exhibits profound anti-tumor activity that prolongs both progression-free survival and over-all survival time in pancreatic cancer patients that had previously failed standard chemotherapy.
Of the 46 patients treated at the 175 mg dose level, 21% attained 6-month progression-free survival (PFS) rate with 16/46 (35%) patients censored for PFS at the time of analysis.
Patients with detectable EBV, but counts less than 5,000 copies/ml have been enrolled in successive cohorts, beginning with the lowest dose level.
If significant side effects occur at any dose level, the study will end and the previous dose level will be considered to be the maximum tolerated dose.