Cyclacel Pharmaceuticals (CYCC)

 

Seliciclib is currently being investigated in the Phase 2b APPRAISE study as a treatment for patients with advanced NSCLC. APPRAISE is a double-blinded, randomized study of single agent seliciclib versus best supportive care in patients with NSCLC treated with at least two prior systemic therapies. APPRAISE is led by Chandra P. Belani, M.D. at Milton S. Hershey Medical Center, Penn State University and Alan B. Sandler, M.D. at Vanderbilt-Ingram Cancer Center. The study’s main objective is to learn the anti-tumor activity of seliciclib as a single agent in refractory NSCLC and help determine further development strategies. The study design is randomized discontinuation. All patients receive seliciclib at a dose of 1200 mg twice a day for three days for at least three cycles of two weeks each. Patients who achieve stable disease after three cycles will be randomized to continue on seliciclib or receive placebo with best supportive care. Patients in the placebo arm who progress will be given the option to cross-over and again receive seliciclib. The primary efficacy endpoint of APPRAISE is progression free survival, or PFS which will be measured in the randomized portion of the study. To detect a 100% increase in PFS from two to four months 80 randomized patients are required. An interim assessment of safety and efficacy will be performed after approximately 40 patients have been randomized.

 

On August 28, 2008, we announced that an independent data review committee or IDRC completed a review of the first interim analysis data from the study. The IDRC assessed the safety profile of seliciclib and recommended that the study continue after reviewing data from the 173 patients with previously-treated NSCLC, of whom 45 proceeded into the blinded portion of the study and were randomized to receive either seliciclib or best supportive care.

 

Based on the interim data, the IDRC reached the following principal conclusions:

 

 

We analyzed the committee’s conclusions and weighed the costs with the expected benefits of continuing the study and we concluded that we would not enroll additional patients. The trial will continue with the patients already enrolled until the last enrolled patient has completed follow-up. In accordance with the protocol, we remain blinded to the study data until this event has occurred.

 

 

Seliciclib is currently being investigated in the Phase 2b APPRAISE study as a treatment for patients with advanced NSCLC. APPRAISE is a double-blinded, randomized study of single agent seliciclib versus best supportive care in patients with NSCLC treated with at least two prior systemic therapies. APPRAISE is led by Chandra P. Belani, M.D. at Milton S. Hershey Medical Center, Penn State University and Alan B. Sandler, M.D. at Vanderbilt-Ingram Cancer Center. The study’s main objective is to learn the anti-tumor activity of seliciclib as a single agent in refractory NSCLC and help determine further development strategies. The study design is randomized discontinuation. All patients receive seliciclib at a dose of 1200 mg twice a day for three days for at least three cycles of two weeks each. Patients who achieve stable disease after three cycles will be randomized to continue on seliciclib or receive placebo with best supportive care. Patients in the placebo arm who progress will be given the option to cross-over and again receive seliciclib. The primary efficacy endpoint of APPRAISE is progression free survival, or PFS which will be measured in the randomized portion of the study. To detect a 100% increase in PFS from two to four months 80 randomized patients are required. An interim assessment of safety and efficacy will be performed after approximately 40 patients have been randomized.

 

On August 28, 2008, we announced that an independent data review committee or IDRC completed a review of the first interim analysis data from the study. The IDRC assessed the safety profile of seliciclib and recommended that the study continue after reviewing data from the 173 patients with previously-treated NSCLC, of whom 45 proceeded into the blinded portion of the study and were randomized to receive either seliciclib or best supportive care.

 

Based on the interim data, the IDRC reached the following principal conclusions:

 

 

We analyzed the committee’s conclusions and weighed the costs with the expected benefits of continuing the study and we concluded that we would not enroll additional patients. The trial will continue with the patients already enrolled until the last enrolled patient has completed follow-up. In accordance with the protocol, we remain blinded to the study data until this event has occurred.

 

 

Seliciclib is currently being investigated in the Phase 2b
APPRAISE study as a treatment for patients with advanced NSCLC.
APPRAISE is a double-blinded, randomized study of single agent
seliciclib versus best supportive care in patients with NSCLC
treated with at least two prior systemic therapies. APPRAISE is
led by Chandra P. Belani, M.D. at Milton S. Hershey Medical
Center, Penn State University and Alan B. Sandler, M.D. at
Vanderbilt-Ingram Cancer Center. The study’s main objective
is to learn the anti-tumor activity of seliciclib as a single
agent in refractory NSCLC and help determine further development
strategies. The study design is randomized discontinuation. All
patients receive seliciclib at a dose of 1200 mg twice a
day for three days for at least three cycles of two weeks each.
Patients who achieve stable disease after three cycles will be
randomized to continue on seliciclib or receive placebo with
best supportive care. Patients in the placebo arm who progress
will be given the option to cross-over and again receive
seliciclib. The primary efficacy endpoint of APPRAISE is
progression free survival, or PFS which will be measured in the
randomized portion of the study. To detect a 100% increase in
PFS from two to four months 80 randomized patients are required.
An interim assessment of safety and efficacy will be performed
after approximately 40 patients have been randomized.

 

On August 28, 2008, we announced that an independent data
review committee or IDRC completed a review of the first interim
analysis data from the study. The IDRC assessed the safety
profile of seliciclib and recommended that the study continue
after reviewing data from the 173 patients with
previously-treated NSCLC, of whom 45 proceeded into the blinded
portion of the study and were randomized to receive either
seliciclib or best supportive care.

 

Based on the interim data, the IDRC reached the following
principal conclusions:

 

 

We analyzed the committee’s conclusions and weighed the
costs with the expected benefits of continuing the study and we
concluded that we would not enroll additional patients. The
trial will continue with the patients already enrolled until the
last enrolled patient has completed
follow-up.
In accordance with the protocol, we remain blinded to the study
data until this event has occurred.

 

 

Seliciclib is currently being investigated in the Phase 2b
APPRAISE study as a treatment for patients with advanced NSCLC.
APPRAISE is a double-blinded, randomized study of single agent
seliciclib versus best supportive care in patients with NSCLC
treated with at least two prior systemic therapies. APPRAISE is
led by Chandra P. Belani, M.D. at Milton S. Hershey Medical
Center, Penn State University and Alan B. Sandler, M.D. at
Vanderbilt-Ingram Cancer Center. The study’s main objective
is to learn the anti-tumor activity of seliciclib as a single
agent in refractory NSCLC and help determine further development
strategies. The study design is randomized discontinuation. All
patients receive seliciclib at a dose of 1200 mg twice a
day for three days for at least three cycles of two weeks each.
Patients who achieve stable disease after three cycles will be
randomized to continue on seliciclib or receive placebo with
best supportive care. Patients in the placebo arm who progress
will be given the option to cross-over and again receive
seliciclib. The primary efficacy endpoint of APPRAISE is
progression free survival, or PFS which will be measured in the
randomized portion of the study. To detect a 100% increase in
PFS from two to four months 80 randomized patients are required.
An interim assessment of safety and efficacy will be performed
after approximately 40 patients have been randomized.

 

On August 28, 2008, we announced that an independent data
review committee or IDRC completed a review of the first interim
analysis data from the study. The IDRC assessed the safety
profile of seliciclib and recommended that the study continue
after reviewing data from the 173 patients with
previously-treated NSCLC, of whom 45 proceeded into the blinded
portion of the study and were randomized to receive either
seliciclib or best supportive care.

 

Based on the interim data, the IDRC reached the following
principal conclusions:

 

 

We analyzed the committee’s conclusions and weighed the
costs with the expected benefits of continuing the study and we
concluded that we would not enroll additional patients. The
trial will continue with the patients already enrolled until the
last enrolled patient has completed
follow-up.
In accordance with the protocol, we remain blinded to the study
data until this event has occurred.