Lumeda Taking over Roswell Pk IO-PDT NSCLC Photofrin Phase 1Roswell Park first posted this phase 1 trial on ClinicalTrials.gov more than 2 years ago, on Sept 19, 2018 but have not yet started recruiting:
NCT03678350 - Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery Lumeda has taken over this phase 1 trial. On their website, they recently posted the timelines for 3 trials - this trial, a succeeding phase 2 trial and an additional phase 1 trial for a combination PDT + Immunotherapy.
"Lumeda has initiated three clinical studies to first establish safety (Phase I), followed by effectiveness (Phase II) of IO-PDT as an adjuvant to NSCLC tumor resection using the DigiLum™ system. In addition, the study plan will include assessment of the effect of PDT on the immune contexture of NSCLC patients, as well as establishing safety of PDT (Phase I study) when used in Combination PDT + Immunotherapy." The thought crossed my mind that this additional phase 1 trial may be for
TLD1433 rather than
photofrin. The reason I say this is because Lumeda makes explicit what they mean by
COMBINATION PDT + IMMUNOTHERAPY on the Technology page of their website:
"COMBINATION PDT + IMMUNOTHERAPY
PDT provokes a strong acute inflammatory reaction observed as localized edema at the targeted site- a result of PDT-induced oxidative stress which can activate an immune response against tumor cells. NSCLC tumors are infiltrated with cells that secrete immunosuppressive cytokines and express immunoregulatory, checkpoint molecules that impair anti-tumor immunity. Numerous recent studies indicate that cancer tumors treated with PDT can stimulate the host antitumor response and alter the immune contexture to overcome tumor immunosuppressive activity and potentially open a window for broader use of immunotherapy. Lumeda is working with institutional partners to study the immune response of NSCLC to PDT, leading to the development of a combination PDT + Immunotherapy as a first-line treatment of later stage NSCLC and Malignant Mesothelioma."
This second phase 1 trial could be the same as the 12 patient photofrin phase 1 trial, except that the photosensitizer would be,
TLD1433 with it's pre-clinically demonstrated immune response. Here is their timeline for this second phase 1 trial:
Study Start Primary Completion Initial Results Q2-21 Q2-22 Q1-22