In the Phase 1 study SpectraCure is conducting for the treatment of patients with relapse of prostate cancer, the third and final level of the drug dose has now been achieved. The first full-dose patient was treated this week at the Princess Margaret Cancer Centre in Toronto, Canada. The treatment method, called photodynamic therapy (PDT), means that the patient is given a light-sensitive drug that accumulates in the tumour. When the cancer tissue is illuminated by laser light of the correct wavelength, the drug is activated and knocks out the tumour.
In the study, the drug dose (Verteporfin) has been progressively increased in three steps, and no significant adverse reactions have been observed. Then the laser light dose will be increased in, up to, three steps.
– It is gratifying that we have now reached so far that we have achieved a full dose of drug in the study, says the responsible doctor in the study Neil Fleshner, professor and chair at the Urology department at the hospital in Toronto. No side effects have been recorded so far. At the next treatment we will start increasing the light dose with the SpectraCure system, and we are approaching the PDT dose that we expect is needed to achieve full effect.
Until now, the clinical Protocol has stipulated a follow-up period of at least one month between treatments. In the latter part of the study that starts at the next level, several patient treatments can be performed in a short time. The treatments in the Phase 1 study will continue for the remainder of 2017. After the final treatment in Phase 1, a continuation of a Phase 2 study is foreseen, in which a group of patients will be treated with the treatment dose established in Phase 1.
The target group of the study is patients who had relapsed prostate cancer after having undergone radiotherapy. For this patient group there are no curative treatment options in routine care, and they are normally referred to hormone therapy to inhibit tumor growth. Hormonal treatment often causes undesirable side effects. SpectraCure aims to offer a curative treatment option for these patients, with fewer and less severe side effects.
