FierceMedicalDevices recently caught up with Cell>Point President David Rollo. Cell>Point, which is based in Centennial, CO, is developing universal oncology, cardiology, stroke and diabetes molecular imaging agents, as well as intranuclear metallic therapeutics.
The company has worked with a number of big names, including the University of Texas M.D. Anderson Cancer Center, Philips Medical Systems and Eli Lilly. Perhaps this is because Cell>Point's approach is different--focusing on the diagnosis and staging of cancers with the goal of ultimately increasing access to cancer imaging. And as Rollo told FMD, staging cancer helps boost the chances for a better outcomes--allowing for more accurate diagnosis, increasing life expectancy and reducing treatment-related costs.
Back in June, the company reported results from a Phase II study of its molecular imaging agent--99mTc‐EC‐G--in patients with non-small cell lung cancer. The company imaged 22 patients with its 99mTc‐EC‐G SPECT/CT and FluoroDeoxyGlucose PET/CT to diagnose and stage their cancers.
FluoroDeoxyGlucose, or FDG, injected and then imaged with a PET camera, is the current standard for cancer diagnostic imaging. However, PET imaging is on the decline in the U.S., as Rollo points out. While roughly 250 hospitals have PET or PET-CT, more than 5,000 have SPECT, or single photon emission computed tomography. Furthermore, PET/CT systems can cost between $1.5 million and $2.5 million, while SPECT/CT cameras cost $500,000 to $650,000, according to the company.
Results from the Phase II study showed 100% concordance between 99mTc‐EC‐G and FDG when experts assessed the location, size and confidence that detected lesions represented cancer. The company is pleased with these results and believes they are sufficient to move on to Phase III, Rollo told FMD. And, he added, because EC‐G is not taken up in inflammation or infection--unlike FDG--it could allow for fewer false positives and potentially be used to assess efficacy of chemotherapy during therapy.
Rollo says his company plans to being a study before the end of the year. The trial will be larger--with 165 to 170 patients in each arm--and conducted at 45 to 50 sites in the U.S. and Canada.
Cell>Point was founded in 2001 and receives funding from private investors--no venture capital, Rollo said. Its big quest now is to find a licensing partner for its agent responsible for the marketing and distribution.