Galera Therapeutics Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Galera Therapeutics is developing selective small molecule superoxide dismutase SOD mimetics for the prevention of radiation induced toxicities in cancer patients and for the treatment of cancer In vivo studies demonstrated that Galera mimetics did not interfere with the anti tumor actions of standard chemotherapeutic or radiation therapy and in fact based on preclinical studies in an animal model of lung cancer the mimetics may sensitive tumors to radiation One such agent GC recently completed a multicenter Phase b a with Intensity Modulated Radiation Therapy IMRT and concurrent cisplatin to reduce the incidence and severity of oral mucositis OM in patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx clinicaltrials gov identifier NCT and is currently enrolling patients for a Phase trial in a similar patient population NCT In this FastTrack application Galera proposes to evaluate GC as a radioprotectant in patients receiving Stereotactic Body Radiation Therapy SBRT for the treatment of lung cancer The conduct of this research study will be contingent on the continued success in NCT NCT and the results of the preclinical studies described in Phase of this proposal The specific aims for Phase are to quantify the ability of GC to prevent pulmonary damage measured via CT imaging immunohistochemistry and histology in mice exposed to SBRT like regimens and to evaluate the effect of GC on a panel of circulating cytokines growth factors and redox markers to gauge the predictive value for subsequent clinical studies For Phase of the proposal a single arm Phase clinical study will assess the effects of GC on SBRT related pulmonary toxicity in patients with early stage lung cancer and limited metastatic lung disease It is predicted that GC will reduce the levels of DLCO loss post SBRT due to its ability to suppress fibrosis and inflammation and ultimately reduce the frequency of patients with significant DLCO changes from baseline The dose of GC for the present study will be selected based on results from the ongoing Phase I OM trial NCT and from the in vivo studies in Phase of this application The specific aims for Phase are to assess the efficacy of GC in limiting pulmonary toxicity in patients receiving SBRT as measured by pulmonary function with DLCO changes the primary endpoint and to evaluate levels of clinical and radiographic pneumonitis radiographic evidence of pulmonary fibrosis the effect of GC and SBRT on progression free survival obtain preliminary information about the anti tumor effect of the combination of GC and SBRT If successful the results of this study will enable further Phase II studies intended to improve the treatment outcomes for NSCLC patients Stereotactic Body Radiation Therapy SBRT is emerging as an important tool in the treatment of poorly controlled lung cancers GC a drug under development to reduce radiation side effects in cancer patients recently completed a clinical trial in head and neck cancer patients Based on the results from this study GC has the potential to improve the treatment of lung cancer patients by reducing radiation side effects and potentially increasing the effectiveness of radiation therapy