Philogen S.p.A. of Siena, Italy, recently launched a pivotal clinical trial in patients with stage 3B/C melanoma, after promising results from its Phase 2 trial of a novel immunotherapeutic combination treatment.
Patients with stage 3B/C melanoma are at high-risk of progression to stage 4 of the disease, the most aggressive and usually fatal stage of melanoma. For patients with Stage 3B/C, surgery is the first therapeutic strategy to cure the disease. Unfortunately, for most of the patients, melanoma returns and further surgery is no longer an option.
In these situations, to eradicate metastatic lesions, a biotherapeutic approach could be an option to prevent melanoma progression and to prolong the survival of patients.
In a previous Phase 2 clinical trial, Philogen, in collaboration with Clinical Centers, showed that an intratumoral injection of two immunocytokines (called L19-IL2 and L19-TNFa) was able to reduce or eliminate lesions, with durable responses and excellent cosmetic results. Additionally, results revealed there was clinical evidence of systemic bystander effects on non-injected lesions, suggesting the start of an anti-cancer immunity effect.
In December, the Competent Authorities of Italy and of Germany approved a global multi-center controlled Phase 3 pivotal trial, which will initially include 15 top European dermato-oncology clinical centers.
“We are pleased to be working with key opinion leaders in the field of cancer immunotherapy, and to be exploring the potential of our immunocytokines to provide benefit to patients,” Dr. Duccio Neri, Philogen’s CEO, said in a press release.
The familial risk and heritability of several types of cancer in a large population of identical and fraternal twins was the subject of a recent long-term study, revealing that having a twin diagnosed with cancer means a significantly higher risk for the other twin to develop any type of cancer.
A significant hereditability was found for certain types of cancer, such as skin melanoma. The research paper, “Familial Risk and Heritability of Cancer Among Twins in Nordic Countries,” was published in The Journal of the American Medical Association.