Scancell Holdings (AIM: SCLP) - action set to accelerate trial enrollment
SCLP.L
Comment by Objective Capital , Feb 04, 2011 download full report
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The recent news on expanded patient inclusion protocols, increased number of recruitment centres, and approval from the safety committee to commence enrolling the second cohort will speed SCIB1 trial.

Objective's view:

New centres to the rescue
Scancell recently received approval for a fourth UK patient recruitment site for its SCIB1 Phase I study and has plans to bring a fifth centre on-line in short order. These two additional sites had been in the works all along, but the original plan was to bring them in for the upcoming Phase II trial.

Review Committee gives thumbs-up to escalate dose and recruit next cohort
With the completed dosing of the first cohort, the Committee has analyzed the data and approved the advancement of the trial to the second cohort, escalating the dosage in the process.

Approval attained for expanded patient population
In further broadening the net for new patients, Scancell has received permission to enroll less sick patients in the remaining Phase I cohorts. Not only should this speed the pace of enrollment, but it also should improve the immune responses of the patients as later stage melanoma patients typically have weakened immune systems.

Competitive trials less of an issue; enrollment dynamics should improve
Two late stage melanoma products have made it more difficult for Scancell to enroll patients in its Phase I trial for SCIB1. While competitive trials1 will remain a challenge, the protocol amendment noted above allowing for all Stage III and IV malignant melanoma patients to participate should significantly help recruiting for this trial.

Interims filed, results in-line with our expectations
The costs incurred in the first half of the fiscal year were in-line with our forecasts. As noted in an earlier note, however, the likelihood of licensing revenue in the calendar year has diminished with the delays in the Phase I trial. In turn, we believe there will be a need to raise capital as early as this summer.

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