Favorable pharmacokinetics/pharmacodynamics (PK/PD) reveal prolonged exposure and CD33 saturation at dose levels
six and seven.
88 percent, respectively, whereas efficacy at two dose levels
with the same dose rate was 83.
This Phase I study is designed to evaluate the safety of PLX-PAD on three dose levels
in patients diagnosed with CLI.
But an informal poll taken at the meeting of members' opinions indicated that most favored allowing the product to remain available at greatly reduced recommended dose levels
, with better labeling to highlight potential adverse effects, and with tighter quality control over manufacturing.
Cohorts of ten patients were enrolled at each dose level
with two patients randomized to receive placebo treatment.
We hope that the administration of the intermediate dose level
will provide further evidence that PLX-PAD is potentially a safe and effective treatment option for patients with CLI.
The proposed enrolment in the trial depends on how many dose levels
are required to reach maximum tolerated dose.
Of the 38 patients enrolled at the 125 mg dose level
as of October 12, 2009, 18 patients had at least one post-baseline scan available that had undergone IRF evaluation.
Upon achieving safe and well tolerated data from the First Cohort of Phase 1b/2a, the Data Review Committee (DRC) advised the company to proceed with cohort 2 and to escalate the dose level
4 mg/kg dose level
had an objective partial response (PR) by RECIST criteria.
The third dose level
of IPP-204106 has just begun in the next group of patients.
In the Phase I/II cancer trials, 36% (9 of 25) of the end stage colorectal cancer patients who received the highest dose level
of DAVANAT([R]), were stabilized from 2 to 8 months.
The objective of this phase will be to further confirm the safety profile, pharmacokinetics and pharmacodynamics of Debio 0932 at a potential Phase II dose level
and to screen anti-tumour activity in patients with certain types of advanced solid tumours.
The 30 mg SC was compared to a combined IV dose group with an average dose level
of 22 mg and showed superior response times for both beginning of improvement (26 minutes vs.
The GLYX-13 Phase I trial was a randomised, double-blind, placebo-controlled single ascending dose level
study of the safety, tolerability and pharmacokinetics of four dose levels
of GLYX-13 in healthy volunteers.