Small biopharm company hatches plan to unseat FDG

A six-year-old biopharmaceutical company with a four-person staff wants to do for SPECT what the makers of FDG did for PET. And they expect to start doing it within 18 months. That's how long the executives at Houston-based Cell Point figure it will take them to get technetium-bearing ECDG (ethylenedicysteine-deoxyglucose) through the FDA and onto the U.S. market. The stakes are enormous.

If this radiotracer meets expectations, it will rival or surpass FDG as the agent of choice for imaging certain types of cancer. It may even be used to screen for heart disease. And there's plenty of reason to believe it can do both.

ECDG, like its glucose-based forerunner, is candy to cells with a high metabolic rate, such as non-Hodgkins lymphoma, head and neck cancer, and lung cancer. It is also consumed voraciously by an ischemic myocardium, whose oxygen-starved tissues turn from metabolizing fatty acid to burning glucose.

Adding to its appeal is the propensity of this tiny biomolecule to combine with high-energy radioisotopes, such as rhenium, which might be swapped for technetium after diagnostic tests have proved the presence of cancer, turning ECDG into a therapy delivery system.

Unlike monoclonal antibodies that hook to antigens on the surface of cells, ECDG passes through the membrane masquerading as a nutrient, hauling technetium or rhenium along with it and destroying cancer from the inside out.

Whether ECDG turns out to be a pipe dream or the first product from Cell Point's pipeline may be determined by phase II and III clinical trials slated for this spring and summer. Clinical tests are being spread across a half-dozen or so medical centers, including ones at the University of Maryland and Johns Hopkins University, where a total of between 100 and 120 cancer patients will undergo ECDG exams, as well as PET scans for benchmarking.

The potential of this molecule to do what Cell Point execs say it will has been borne out by preliminary clinical tests and preclinical studies, enough so that last year Dr. F. David Rollo, chief medical officer for Philips Medical Systems, jumped ship to become Cell Point's president.

Rollo was a convert to the preachings at Cell Point long before then, as he negotiated an alliance with the start-up in 2003. In his new job, Rollo has taken charge of the clinical trials that are pivotal to the company's-and possibly SPECT's-future.

But already Cell Point has had an impact on the nuclear medicine community, as it led directly to the evolution of high-performance SPECT/CT. The reason was simple: If ECDG agents were to be localized, CT would be needed to sketch in the surrounding anatomy. This argument, made successfully by Rollo, led Philips' strategists to sanction the development of that company's line of high-performance hybrids, the Precedence SPECT/CTs.

But Rollo knew that even the most powerful CT would not be enough. Special software would be needed to interpret ECDG scans. These scans would visualize hot spots created by the presence of agents targeted on specific tissues, not the cold spots produced by traditional nuclear medicine.

Philips and Cell Point custom developed software to image technetium-ECDG, commercially releasing this product, called Astonish, three years ago. Bred for an age of medicine that had not yet arrived, Astonish was positioned to do what it could at the time: improve resolution of conventional scans and suppress noise. It has since blended into a class of other products bearing hyperbolic names and performing mundane functions-and waited, along with Precedence, for the launch of ECDG.

With product portfolios and experimental radiotracers hanging in the balance, the months ahead will be laden with expectation.