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SL052 for Prostate Cancer – Phase I Clinical Trial

SL052 is an injectible formulation of another HB derivative and is indicated for prostate cancer. It is anticipated that the compound will be injected intra-arterially or intravenously into patients and will selectively accumulate in the target tissue (prostate tumor). The SL052 photosensitizer will then be activated by laser light delivered through multiple optical fibers under the control of a sophisticated computerized control system.

The Phase I Clinical Trial is concluded in two stages:

Stage 1

  • Assess prostatic localization of SL052 after Intra-arterial administration
  • 6 subjects undergoing radical prostatectomy
    • Assessments:
    • Visual Examination
    • Fluorescent Microscopy

Stage 2

  • Assess safely and tolerability of interstitial PDT with SL052
  • Assess efficacy of PDT treatment

12 subjects with localized prostate cancer

  • 3 groups of 3 patients treated with ascending light dose with single light fiber
  • 1 group of 3 patients with highest tolerable light dose with multiple fibers

SL052 for Prostate Cancer is designed to be more effective than current treatments in destroying the cancerous tumors on the prostate while limiting collateral damage to healthy tissue. Pre-clinical studies in small and large animals have demonstrated the effectiveness of SL052 in selective destruction of normal and cancerous prostate tissues, with minimal side effects. The use of 18 F FDG (flurodeoxy glucose) PET imaging pre and post PDT treatment, highlighted the complete shut down of metabolic activity at the tumor site 24 hours after PDT treatment.

The practical application of this new PDT treatment system on the prostate gland has also been demonstrated using a canine prostate model. The intra-arterial drug delivery system allows the selective and significant accumulation of the photosensitizer in the prostate which is easily confirmed by fluorescence detection. PDT treatment of the prostate gland causes complete glandular tissue ablation within the intact capsule. Sexual and urological functions appear to be intact after the treatment with some acute voiding
difficulties observed within the first few days.

Florescence
HE Stained
Tumor Pre-treatment
35 Days Post SL052 PDT

Tumor ablation with SL052 Photodynamic therapy in a mouse tumor model

 

PET Imaging Pre and Post PDT Treatment

Florescence


PET Imaging (Light Only Control)

Florescence


Canine Prostate Glandular Tissue Ablation Post SL052 PDT Treatment

Florescence