Princeton, NJ-based Celator Pharmaceuticals has raised close to $40 million, enough to get its lead cancer drug--a reformulation of standard drugs infused in nano-sized delivery vehicles--through a pivotal late-stage study that is now enrolling patients with secondary cases of acute myeloid leukemia.
Valence Life Sciences led this latest fundraising for Celator, which includes $32.5 million in a final closing and an additional $6.8 million from an initial buy-in. That money will be used to finance a 300-patient trial of CPX-351, with investigators comparing the overall survival of patients with a control arm which will receive standard doses of cytarabine and daunorubicin.
CPX-351 is a special formulation that uses a 5-to-1 ratio of cytarabine-daunorubicin packaged in tiny lyposomes to maintain the ratio as it is delivered intravenously to patients, offering an approach that could amp up efficacy and help guard against side effects. Celator uses a platform technology, CombiPlex, to find the most "synergistic" formulations of drugs.
In a Phase II study, CEO Scott Jackson tells FierceBiotech their formulation of the AML drugs delivered higher remission rates and a reduction in early mortality as well as improved progression-free survival and overall survival. The trial arm including secondary AML patients--a group that, for example, may have had a prior malignancy--responded particularly well, and that's the focus for Phase III.
According to company documents, CPX-351 produced a 23.3% improvement in the clearance rate of leukemia, a significantly better response rate and a 60-day mortality rate that was three times lower than the standard drug arm. The OS was 14.7 months for CPX-351 and 12.9 months for the standard formulation, but patients also had an opportunity to cross over once their disease progressed, which could have blunted the survival rate.
There's enough money committed in this latest financing to get the company to Q2 2016, right after Celator expects to have pivotal data in hand. At that point, says Jackson, the company has several options, provided the data are positive.
"We do have various routes we could with the asset," says Jackson. And those options include partnering in the U.S. while retaining co-promotion rights or doing a global deal. "We'll look at what maximizes shareholder value."
Celator registered its securities with the SEC through Form 10, a process that requires the biotech to file financial reports like a 10-K publicly. Its latest report notes that the biotech, which has a staff of 17, has spent $115 million in pursuit of its drug development work, which includes a second clinical-stage project for CPX-1.
- here's the release