The treatment of all 18 patients with localized prostate cancer in LIDDS´ second phase IIa-study with its first product Liproca® Depot has now been completed and the evaluation of the results has been initiated. A final version of the report is expected in October 2013.
Preliminary results indicate:
- Clear dose response relationship regarding reduction of both PSA and prostate volume
- More rapid onset of PSA reduction compared to corresponding data for oral flutamide 750 mg/day
- Few and minimal side effects as the plasma concentrations of the antiandrogen are significantly lower than after oral treatment
- Dose response relationship from this study indicates that even higher doses of Liproca® Depot are likely to give an effect on PSA and prostate volume at least in line with current oral treatments. Such higher doses are likely to give low side effects due to lack of systemic impact and consequently a more favorable benefit/risk ratio.
The new clinical data and a proposed clinical drug development program has recently been the subject for separate scientific meetings with the Swedish MPA and the Finnish FIMEA. The next step in the clinical development of Liproca® Depot is a dose-finding study in patients with localized prostate cancer. The first indication for Liproca® Depot will be neo-adjuvant treatment prior to radiation therapy in patients with low to medium risk localized prostate cancer. This is expected to be a 100 MUSD opportunity. In the pivotal study for this indication, Liproca® Depot will be compared with systemic treatment as neo-adjuvant treatment 6 months prior to radiation therapy. The PSA-kinetics will be the primary effect parameter and plasma concentration kinetics and tolerance (QoL) will be secondary. The patients will be monitored during 2-3 years after radiation as a post approval follow up. After obtaining the first market authorization the use of Liproca® Depot can then be widened beyond as neo-adjuvant therapy to radiation but within the scope of localized prostate cancer, e.g. as monotherapy for elderly patients, who are today offered “watchful waiting”, or to patients who are not willing to accept the side effects from any of the treatments being offered today. A third group is younger men interested in delaying more aggressive treatment, i.e. prostatectomy and radiation.
LIDDS is now seeking a partner or acquirer to support the continued clinical development program and the preparation of the dossier to obtain marketing authorization.