Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor
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Dr. Selvaggi was instrumental in the development and approval of lung cancer drugs Zykadia for Novartis and Opdivo forBristol Myers Squibb -
CEL-SCI ’s Multikine immunotherapy improves the 5-year survival of head and neck cancer patients to 73% compared to 45% in controls and cuts the 5-year risk of death by 50% -
FDA has given
CEL-SCI the go-ahead to commence a confirmatory Registration Study for Multikine for the target population in head and neck cancer -
Dr. Selvaggi will be supportingCEL-SCI to bring Multikine to patients through a confirmatory registrational path that has been agreed with regulatory authorities and that has a potential for cure
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Multikine is the first investigational pre-surgical cancer drug in newly diagnosed head and neck cancer. Multikine is a copy of the pro-inflammatory cytokine immune response human bodies produce every day and is designed to empower a person’s intact immune system cells to attack their own cancer. Patients are treated with Multikine right after diagnosis, before any other standard of care treatment (surgery and radiation therapy) since that is when the immune system is strongest. There is robust safety and efficacy data from 750 patients who have been treated with Multikine.
Based on the following efficacy data, the FDA has agreed to CEL-SCI’s 212-person Registration Study to confirm the findings for regulatory approval:
- No safety signals vs standard of care
- 73% survival for Multikine vs 45% in the control arm at 5 years
- Statistically significant p = 0.0015
- 5-year risk of death cut in half from 55% to 27% (Hazard ratio = 0.35 (95% CIs [0.19, 0.66])
- More detailed results may be viewed here: LINK
“Dr. Selvaggi has a passion for bringing cancer drugs to market to save lives and lead clinical research toward a cure for cancer. We are excited to have him join
About
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients.
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* Multikine (Leukocyte Interleukin, Injection) is the trademark that
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