A handful of Columbus, Ohio-area organizations are combining their strength to get one of the companies’ drugs — a radiopharmaceutical that identifies cancerous lymph notes in patients with breast cancer and melanoma — into the marketplace.
To begin with, Phylogeny Inc. in Columbus and Neoprobe Corp. in Dublin will work together to develop head and neck cancer detection technologies. The American Society of Clinical Oncology estimates head and neck cancer accounts for up to 5 percent of all cancers in the United States.
Phylogeny is a contract research organization that does “in situ hybridization,” which is a method of localizing and detecting DNA and its component RNA that enables client companies to do functional genomic research.
Neoprobe (OTCBB: NEOP) is developing radiopharmaceuticals — radioactive agents that are injected or ingested to create medical images — for the detection of cancer. In December, the company that has yet to market its first drug finished a Phase 3 clinical trial of Lymphoseek, which maps sentinel lymph nodes — the first stop in the lymphatic system for tumor drainage.
Neoprobe has been talking to the Food and Drug Administration for months about filing a new drug application, better known as an NDA, to market Lymphoseek. The company hopes to file that application this summer. However, Neoprobe would like to add to the application a use claim for sentinel lymph node mapping and identification.
Expanding the intended use for Lymphoseek would help the drug reach its full potential as an economic opportunity for Neoprobe and its community, as well as produce the best outcomes for cancer patients, according to the company’s application for an Ohio Third Frontier grant.
An additional Phase 3 trial is needed to expand the use of the drug. Neoprobe intends to enroll about 390 patients in the trial that will figure the rate at which Lymphoseek fails to find cancerous lymph nodes, the company said in its grant application.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Phylogeny will help by evaluating Lymphoseek’s accuracy in detecting metastatic cells — an important step for FDA approval, according to a Business Wire release by the company. Phylogeny said it also would act as a central pathology lab for Neoprobe’s additional clinical trial.
“It is rare to have two companies that have such complementary expertise and technologies just a few miles apart,” said Adel Mikhail, Phylogeny’s chief executive, in the release.
Neoprobe executives agree. “We are fortunate to have local access to renowned clinics and companies that can help support clinical efforts for a product from inception to the clinic,” said Fred Cope, vice president of Pharmaceutical Research and Clinical Development for Neoprobe.
The two companies are collaborating on a $1 million grant proposal to the Ohio Third Frontier’s Medical Imaging Program, which is expected to announce grant winners next week. Neoprobe, the lead applicant for the grant, would use the money for its additional clinical trial at sites that include Ohio State University Medical Center and the Cleveland Clinic.
Neoprobe would partner with Dublin-based Cardinal Health Inc. (NYSE: CAH) to market and distribute the drug. Early this week, John Rademacher, Cardinal Health’s president of Nuclear and Specialty Pharmacy Services, talked with MedCity News about his company’s expanding role as an enabler of research and development on the frontier of nuclear medicine.
The goal of the additional clinical trial “is to maximize the commercial opportunity embodied in Lymphoseek and to enable significantly expanded and sustained revenue growth and profitability of Neoprobe and its corporate partners, including Cardinal Health, and to provide Ohioans with increased opportunities for high-skill/high-wage employment,” Neoprobe said in its grant application.
Even if the company’s Third Frontier proposal is rejected, Neoprobe and Cardinal Health have “committed … to bring Lymphoseek to its fullest fruition.”
