Celsion Corporation (CLSN) announced that it has submitted a phase I study protocol for GEN-1, its DNA-based immunotherapy for the localized treatment of cancer, to the FDA for a 30-day review and comment period.
The protocol was designed to find a safe and tolerable dose of GEN-1 in newly diagnosed ovarian cancer patients. These patients will be undergoing neoadjuvant chemotherapy. Celsion intends to start the study in the second half of the year.
In an earlier phase I monotherapy study, GEN-1 demonstrated encouraging safety and efficacy data. The candidate is currently in a phase Ib study in combination with PEGylated doxorubicin in patients suffering from platinum-resistant ovarian cancer.
The market for ovarian cancer drugs currently looks highly crowded. Last month, we saw AstraZeneca’s (AZN) Lynparza getting approval in the U.S. for the treatment of BRCA-mutated advanced ovarian cancer patients previously treated with three or more prior lines of chemotherapy.
Celsion’s GEN-1 is also being developed for the treatment of patients suffering from glioblastoma multiforme. The company plans to start a phase I study on the candidate in this indication.
Celsion currently has no approved products in its portfolio. Celsion’s primary candidate, ThermoDox is being developed for a number of oncology indications – primary liver cancer (phase III OPTIMA study) and breast cancer (phase II Euro-DIGINTY study). We expect investor focus to remain on the company’s pipeline going forward.
Celsion currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Affymetrix Inc. (AFFX) and Incyte Corporation (INCY). Both stocks carry a Zacks Rank #1 (Strong Buy).
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