CytoVac chose first to focus on patients with prostate cancer, since these patients have significant treatment needs that are not covered by existing treatments. The patients that have been entered into these studies are late stage Prostate cancer (Castrate Resistant Prostate Cancer (CRPC)) patients. Both patients with and without metastasis have been included.
From the phase I testing of ALECSAT it is seen that the immunotherapy treatments are well tolerated safe and applicable for prostate cancer patients. There have been several positive indications for clinical effect; however, due to the low number of patients exposed no statistically valid efficacy conclusions can be made.
So based on this clinical phase I data, ALECSAT treatments of Prostate cancer should move to clinical phase II testing where statistically relevant efficacy data may be obtained. CytoVac aims to explore this opportunity in collaboration with a partner.
In 2009, Cytovac initiated the first clinical trial in prostate cancer. This was a prospective, open-label, single center, phase I trial of 12 weeks duration, to investigate the safety and tolerability of a single dose of ALECSAT in 13 patients with late-stage castrate-resistant prostate cancer (CRPC). The trial was completed in 2010. ALECSAT treatment was found to be well tolerated and no serious side effects that could be associated to the treatment were seen.
For several patients, positive indications of disease improvement were observed as assessed by a transient decrease or stabilisation in prostate specific antigen (PSA) levels.
The ALECSAT productions, logistics and handling of treatments in the hospital were successful.
In 2011, Cytovac initiated a second larger prospective, open-label, single centre, phase Ib prostate cancer trial of 25 weeks duration. The trial was completed in October 2012. Whereas the first trial (CV001), was a single-dose trial, the 21 patients included in this second phase Ib trial, were treated with 3 doses of ALECSAT. The primary objective was to investigate the safety and tolerability of ALECSAT in patients with late-stage castrate-resistant prostate cancer (CRPC). The secondary objective was to assess indications of a positive therapeutic or palliative effect of ALECSAT.
Repeated ALECSAT treatments were seen to be well tolerated and no serious side effects that could be associated to the treatments were seen. For several patients, indications of possible disease improvement were observed as assessed by decreases or stabilization in prostate specific antigen or by improvements in bone metastases observed by skeletal scintigraphy (reduced number and/or growth of metastases).
Based on the 2 completed clinical trials in prostate cancer it can be concluded:
– Stabilization or decrease in PSA levels (rise in PSA indicates disease progression)
– Reduction in size and/or number of bone metastasis.
These results are encouraging, however, as only few patients were treated in each trial these preliminary results should be further corroborated.