If the trial was expended by 20 more patiants that is an indication on how the trial is going. These patients have no other hopes. They have exhausted all other treatments available. If Dr. Shapiro is enrolling patients with no problem at this point, it means that he is confident to give them the best opportunity. -lorema
Even more convincing are the number of patients who continue dosing after their first cycle. Really, they have completed the trial with this initial cycle, but in consultation with the doctors, are opting to continue with additional optional cycles of Kevetrin dosing.
It's hard to believe they would continue with optional cycles in the Kevetrin trial if they weren't perceiving benefit from Kevetrin, or believed another clinical trial offered greater hope.
The reports we've heard to date give us an indication of what is motivating the patients and doctors to continue patients with the optional dosing cycles, and expand the patients to be treated by 50% from the initial protocol. From 40 patients to 60 patients.
Stabilization - Stable Disease - including periods of 3 - 6 months in patients with progressive stage 4 ovarian cancer that had no other treatment options, other than palliative treatment for symptoms.
A patient with ~11 months stable of stable disease for Thymoma. Again, to enroll the patient had to have run out of available treatment options.
An ovarian cancer patient with a period of stable disease and a metastatic spleen tumour complete response. Yes, a single patient, but ovarian mets are notoriously treatment resistant, and this patient had also completed all available standard of care, other than palliative treatment.
Personally I expect more results from the final data. Especially if we consider that:
A: All patients continuing now are being treated at the higher dose of 450 mg/m2, and if the next higher dose is declared safe, they may move up.
B: The 50% increase of the patient sample will all likely be at a higher dose, at least 450 mg/m2, perhaps higher.