Saladax Biomedical: Making Chemotherapy Safer and More Effective for Cancer Patients
Individuals metabolize anti-cancer drugs at dramatically different rates, leading to as much as a 50-fold difference in the concentration of the medicine in the bloodstream of different patients even when identical doses are administered. This can lead to severe toxicity, illness or even death. Sal Salamone knows there is a better way.
“It’s not the oncologist’s fault by any means,” says Salamone, CEO of Saladax Biomedical, Inc. “The only tools to measure cancer drug levels in patients are used in research settings, and they are not practical for routine analysis.” That’s why his company, based in the Ben Franklin Business Incubator in Bethlehem, is developing a line of tests that quickly, accurately and inexpensively determine levels of chemotherapy drugs in the blood of cancer patients.
Currently, oncologists use Body Mass Index (BMI) as a baseline for determining the dosages that are administered. They use what is known as a “maximum tolerated dosage” approach, increasing the dose until toxicity sets in. “We want to give the right tools to oncologists so that they can make the best possible decisions,” Salamone says.
With the Saladax method, a cancer patient receives a dose of chemotherapy and provides the doctor with a small blood sample. Once the sample is in the lab, it gets combined with a Saladax reagent, which accurately measures the drug level in the patient’s blood. The doctor can then use this information to provide the ideal dosage for each individual patient.
A Home in Pennsylvania
Salamone originally planned to launch Saladax in New Jersey, where he spent 17 years at Roche Laboratories. While there, he launched seven major reagent product lines that have generated more than $800 million for the company.
“Unfortunately, it wasn’t the greatest environment for a startup,” he says. “Pennsylvania really welcomed us with open arms.” Ben Franklin Technology Partners (BFTP) in particular saw great potential in the company and provided Salamone with operating space in the Ben Franklin Business Incubator in 2004. Saladax currently employs seven people.
“We started this business less than three years ago, but with Ben Franklin’s help, we were able to tie up 90 percent of the intellectual property in the field pretty rapidly,” he says. “Ben Franklin also gave us a facility, shared resources in the incubator and helped us hire the right people to get this done right.”
Ben Franklin has invested $450,000 in Saladax since 2004-critical funding that Salamone says is hard to come by from most other sources.
“There’s no such thing as early-stage venture capital funding,” he says. “No one is going to support a new company out of the chute with just an idea-but Ben Franklin did. And that’s all we had in the beginning. Just an idea.” BFTP also helped Saladax refine its investor presentation. As a result, the company has gone on to raise more than $4 million in follow-on funding.
Tremendous Cost Savings, Better Care
Forty percent of the $30 billion cancer drug market goes to drugs that combat chemotherapy-related toxicity. “In addition to providing exponentially better levels of patient care, our tests have the ability to dramatically reduce the need for those supportive therapy drugs, resulting in huge cost savings for a health care system where costs are spiraling out of control,” Salamone says.
Lower toxicity also means fewer hospital admissions due to toxic effects and a decreased incidence of organ damage. “I knew a woman who had breast cancer,” says Salamone. “The good news is, she was able to kick it. The bad news is, she developed cardiac damage as a result of cancer drug toxicity and needed a heart transplant. It shouldn’t be a trade-off.”
Having too much of the drug in your system isn’t always the problem. “If you’re a fast metabolizer, you clear the drugs quickly and won’t get enough in your system to kill the tumor and in fact create a resistant one,” he notes. “If a patient is being under-dosed, our test will pick it up.”
Expecting FDA Approval
Saladax expects FDA approval this year for some of its tests. However, they already have a sales agreement with ARUP Laboratories, one of the largest clinical laboratory companies in the world. Under a special allowance in FDA regulations, a lab can perform pre-FDA approval testing known as “home brew tests” as long as they qualify and validate the results. “ARUP sees a real need for what we are offering, and they want to be the first to carry it,” Salamone says.
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