PURPOSE: Preclinical studies have indicated that BLVR, achieved by administration of a fibrin based Hydrogel into subsegmental bronchi through a flexible bronchoscope, is safe and reduces lung volume by converting hyperinflated emphysematous lung into scar tissue. This abstract summarizes the safety record of BLVR in 15 patients with advanced emphysema and also provides 3 to 6 months efficacy data on 11 patients from the same population.
METHODS: BLVR treatment was administered as part of 3 Phase 1 clinical trials at 4 medical centers. Group A patients (#7) received subtherapeutic treatment targeting 2 subsegments (estimated to represent 4-6% of total lung volume [TLV]). Six of these 7 patients had a second treatment at 2 additional subsegments at a later date. Group B patients (#8) were given potentially therapeutic doses at 4 subsegments (estimated to represent 8-12% of TLV).
RESULTS: There were 21 treatment sessions in 15 patients without intra or postoperative adverse events other than those commonly associated with advanced emphysema and/or fiberoptic bronchoscopy. All patients were discharged from the hospital the day after the procedure. Two of 4 Group B patients in whom 3-6 month data are available, experienced benefits similar to those obtained with successful unilateral lung volume reduction surgery. Changes in spirometry, lung volumes, 6MWD and SGRQ are shown in Table 1.
CONCLUSION: BLVR proved safe during 21 treatment sessions in 15 patients. Treatment of 4 subsegments suggest efficacy in terms of pulmonary function, exercise tolerance and HRQOL. Future clinical trials will target up to 12 subsegments (20-30% of TLV) in an attempt to achieve a therapeutic impact comparable to bilateral lung volume reduction surgery.
CLINICAL IMPLICATIONS: If further clinical trials confirm the results of the preclinical studies and establish the safety and efficacy of BLVR in humans, the procedure would represent a major advance in the treatment of advanced emphysema. BLVR could reduplicate the results of LVRS with greatly reduced mortality and morbidity.
DISCLOSURE: Victor Pinto Plata, Consultant fee, speaker bureau, advisory committee, etc. Aeris Therapeutics, Inc. Woburn, MA 01801; Product/procedure/technique that is considered research and is NOT yet approved for any purpose, Biologic Lung Volume Reduction.