CanariaBio Inc. announces that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy for the treatment of front-line advanced ovarian cancer patients.
SEOUL, South Korea, June 29, 2022 /PRNewswire/ - CanariaBio Inc. (developing its biotechnology assets through its subsidiaries, MH C&C and OncoQuest Pharma US Inc.) announces today that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy (carboplatin and paclitaxel) for the treatment of front-line advanced ovarian cancer patients.
This double blind and placebo controlled multinational trial (FLORA-5, GOG-3035, NCT04498117) is currently accruing patients at over 137 centers in Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan and US; with additional sites in India and Romania being activated. This study seeks to confirm the observations of Brewer et al (Gynecology Oncology 2020 156:523-529) that demonstrated oregovomab in combination with carboplatin and paclitaxel improved both progression free and overall survival relative to chemotherapy which was statistically significant and clinically meaningful in the absence of incremental toxicity.
For this ongoing Phase-III study, the last Independent Data Safety Monitoring Board (IDSMB) meeting held in March 2022 identified no safety concerns and IDSMB recommended to continue the study without modifications.
“We are excited about reaching this important milestone, which is a testament of the hard work that all our investigators, GOG leadership, team members and collaborators has put in, and are grateful to the patients that have participated in the study,” said Dr. Sunil Gupta MBBS, FRCPC, Chief Medical Officer of OncoQuest Pharma US, Inc. (a subsidiary of CanariaBio Inc.) “We remain on track with our projected enrollment, and we are excited about the potential benefits that our drug may bring to patients with ovarian cancer.”
Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in a phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab in combination with chemotherapy had demonstrated a highly statistically significant and clinically meaningful outcome for both progression-free and overall survival compared to standard of care chemotherapy (carboplatin and paclitaxel). The risk of progression and of death was reduced by more than 50% when compared to control arm, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively. To learn more, visit www.FLORA-5.com.
CanariaBio Inc. is a Korean biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer. CanariaBio’s technology platform includes a portfolio of tumor antigen specific monoclonal immunoglobulins targeting CA-125, MUC1, PSA and Her2/neu. The company is exploring the therapeutic potential of these antibodies as indirect immunizers in combination with other immune modulating drugs or drug combinations to address unmet medical needs in oncology.
Forward Looking Statements
This press release includes forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
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