Solid tumors are among the deadliest diseases facing humankind, with many having few treatment options and poor treatment outcomes. While recent advancements in immunotherapy and other technologies have shown a dramatic improvement over traditional chemotherapies, especially in blood borne cancers, effective treatments for many solid tumors remain elusive.
This is where Focal Medical’s direct delivery of anti-cancer agents using energy rather than the vasculature is poised to make existing chemotherapies more effective with fewer systemic side effects. Focal Medical is applying its energy-based iontophoresis drug delivery system to improve local delivery of approved chemotherapeutic agents with the goal of improving outcomes for patients with solid tumors.
Among cancers, malignant pancreatic tumors are particularly insidious and lethal — symptoms are not typically evident until the disease reaches later stages. At diagnosis, the often advanced stage of the cancer and the complex interface between the pancreas and adjacent organs may preclude surgical resection. Five-year survival rates on average are extremely poor. Systemic chemotherapy is often the only treatment option and has yielded limited improvements in life expectancy.
Pancreatic cancer cells are susceptible to anti-cancer agents; the consistent limitation is achieving therapeutic levels of drug in the target organ without causing a deterioration of the patient’s overall health due to systemic toxicity. In our lead program, we’re attempting to shift the paradigm in how therapy is delivered and empower gemcitabine to deliver its anti-cancer effect directly to the tumor locally with the goal to reduce tumor burden, extend survival and increase drug tolerability.
While this is our lead program, we expect to utilize our technology more broadly and open a new treatment approach for a range of challenging to treat solid tumors.
Pancreatic Cancer Facts
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The numbers aren’t good: Currently 62,000 people a year are diagnosed with pancreatic cancer in the U.S. The five-year survival rate sits at 11%.
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Surgery can help but has limits: Surgical resection may be an effective treatment. However, on diagnosis only 15% of patients are eligible for surgery, because the extent of tumor growth and its proximity to other important organs often complicates effective resection. Even when patients undergo surgery, pancreatic cancer may recur because of lingering, micrometastatic disease. Systemic therapy with anti-cancer drugs is often the only option available.
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Drug transport to the tumor faces barriers: Pancreatic tumors largely lack blood vessels, the typical method for delivering and transporting drugs. They’re also heterogenous in nature and encased in a protective shell called the stroma. These obstructions often lead to poor response to drug therapy and poor survival rate.
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Toxic side effects may be significant: Delivery of anti-cancer agents is typically by intravenous infusion. Regular intravenous infusions follow a prescribed course of chemotherapy over several months. The systemic exposure to chemotherapy agents has significant side effects and may impact quality of life.
There may be a better way: If anticancer agents could shrink pancreatic tumors away from adjacent blood vessels and other organs, more patients could undergo resection. Effective therapy could also prevent disease from returning. And even if tumors remain unresectable, better delivery of drugs could still limit tumor growth and improve quality of life while limiting systemic toxicity.
Our plans to revolutionize pancreatic cancer treatment are built on groundbreaking work from cancer laboratories at UNC-Chapel Hill.
The labs developed an implantable iontophoretic device, then tested it on patient-derived xenograft models in mice — models that reflect the same heterogeneity and stromal resistance of pancreatic tumors in humans. Results showed:
- 100% of mice saw an average of 40% decrease in tumor volume following treatment with gemcitabine delivered with our local iontophoresis delivery platform. In contrast, in the same study, tumors treated with intravenous gemcitabine grew an average of 140%.
- 5x higher concentration of gemcitabine in tumors as compared to intravenous infusion while eliminating virtually all systemic exposure.
Head and neck cancers (cancers of the oral cavity, pharynx and surrounding tissue) represent another life-threatening disease with poor prognosis for patients. More than 54,000 new cases occur each year in the United States. with a five-year survival rate of 68%. Typically head and neck cancer is considered a local disease and treatments include radiation, chemo-radiation and surgery. Surgery is an effective alternative for treating this disease but comes at a high cost when the involved tissue includes the delicate structures in the oral cavity such as the tongue, mandible and pharynx. Surgical removal of these structures can leave the patient permanently disfigured or unable to speak or eat properly.
More effective treatments are needed that can shrink tumors prior to surgery or completely eradicate tumors without the need for surgery. Focal Medical has initiated a research program utilizing its energy-based drug delivery system in head and neck cancer. One approach is the delivery of the chemotherapeutic carboplatin directly to the tumor. Another approach is to use carboplatin as a radiosensitizer in conjunction with local radiation to target tumors. Both of these approaches hold early promise and are being explored in partnership with Virginia Tech.
With advances in safety and efficacy, gene therapy has finally started to fulfill its tremendous potential. But even with increasing success replacing, supplementing, or turning off genes, the field continues to evolve rapidly as it seeks to address such issues as off-target activity and unwanted side effects including unwanted immune mediated responses and the need for sustained delivery of therapy.
At Focal Medical, our innovative gene therapy program looks to surmount these challenges. We believe our platform for transferring genetic material via iontophoresis — electrical forces — may add a valuable tool for safely delivering certain genomic medications. Focal Medical’s pipeline expansion plans include products utilizing its innovative technology to deliver gene therapy drugs.
Utilizing iontophoresis to achieve active and targeted, localized delivery, our technology potentially facilitates smaller doses and/or repeat doses, arriving more focused and concentrated.
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