Onconova Therapeutics Inc (NASDAQ:ONTX) dosed the first patient in Phase 2 clinical trial of Rigosertib at the EB House Austria. The company will assess the safety and efficacy of the drug in patients with RDEB (recessive dystrophic epidermolysis bullosa) associated locally advanced SCC (squamous cell carcinoma).
The company expects to open additional trial sites in the US and UK to study this genomically driven and rare deadly disease.
Enrolls 12 patients
Onconova will administer intravenous or oral rigosertib to 12 patients in an investigator-led clinical trial.
The investigator will decide whether to administer oral or intravenous rigosertib to the patients in Phase 2 clinical studies depending on the manifestations of the disease.
Patients will receive 560 mg of oral rigosertib daily twice (in the morning and afternoon) for up to 13 cycles in four weeks. The maximum daily dosage is 1,120 mg.
Alternatively, intravenous rigosertib will be administered to the patients on days 1, 3, 2 of eight weeks and 2, 3, 1 day of fou-week cycles later. The total infusion in 24 hours should not exceed 1,800 mg of the drug.
The company will find the anti-tumor activity using rigosertib in patients with RDEB patients associated with advanced SCC in the first primary endpoint.
In the secondary endpoint, the company will assess the tolerability and safety of the drug in patients with RDEB. The trial duration is up to 2 ½ years, and the patients can be dosed up to one year.
Onconova’s CEO, Steven M. Fruchtman, said the company is thrilled with advancing its Phase 2 clinical studies of rigosertib. The skin blistering disease – RDEB often results in SCC (squamous cell carcinoma) in severe patients. SCC is the chief cause of death in patients.
Rigosertib will be beneficial for patients with this rare disease. DEBRA International sponsors this investigator-led Phase 2 clinical.
Onconova reported a loss of $25.2 million in 2020. Its G&A expenses are $8.3 million in 2020.
Onconova R&D expenses surged marginally to $16.9 million in 2020. It is on the backdrop of higher manufacturing costs and regulatory consulting fees. The company holds cash and CE of $19 million as of December 31, 2020.