under the oversight of Professor Stuart Elborn, MD, of Queens University, Belfast, and is slated to test four dose levels
of oral once-daily CTX-4430 treatment in 36 adult CF patients.
Three patients at the first dose level
received an initial dose of 100 mg followed by three weekly doses of 500 mg, at the second dose level
three patients received a dose of 300 mg followed by three weekly doses of 1000 mg and at the third level, 27 patients received an initial dose of 500 mg followed by three weekly doses of 2000 mg.
IMO-2125 also demonstrated a treatment-related decrease in viral load at escalating dose levels
For example, when we say that 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, or that we hope it will provide further evidence that PLX-PAD is potentially a safe and effective treatment option for patients with CLI, or that the DSMB approval confirms the safety profile of the first dose of PLX-PAD, or that a total of up to 15 adults with CLI will be included in this dose escalating trial, we are using forward-looking statements.
In addition, 89% of patients at this dose level
had a dose interruption of XL184.
The in-clinic dose ranging studies indicate efficacy at various dose levels
with no significant side effects reported.
The cytokines have been implicated as mediators of "capillary leak syndrome," which limits dose levels
of IL-2 in RCC and MM patients.
Our first Phase II clinical trial demonstrated the potential safety and efficacy of Betafectin at a single dose level
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 test results, including the histology of vital organs, indicate absence of toxicity at dose levels
significantly in excess of the recommended dose level
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.
A patient with relapsed SCLC had an unconfirmed partial response after treatment with huN901-DM1 at the 75 mg/m2/day dose level
Up to 48 patients will be enrolled; each dose level
is expected to accrue six patients.
While we are still in the planning stages of this subsequent trial, subject to FDA approval we expect that approximately 390 ALS patients enrolled at 30-35 clinical sites in the United States and Canada will be treated at the highest arimoclomol dose level
In January 2006, CytRx initiated an open-label extension of this Phase IIa trial allowing patients who complete the trial to continue treatment with arimoclomol at the highest dose level
three times daily for up to an additional six months.