KALAMAZOO – ProNAi Therapeutics is a drug development and discovery company founded by pharmaceutical development professionals who chose to stay in Michigan when Pfizer shut down operations in Kalamazoo.

A biopharmaceutical company located at Kalamazoo’s Southwest Michigan Innovation Center, ProNAi is pioneering a new class of therapies for treating cancer; therapies that use naturally occurring genetic material to kill cancer cells. ProNAi’s proprietary technology ? DNA interference (DNAi) ? acts at the DNA level where only two copies of the gene exist per cell so treatment can be targeted more efficiently.

“Our drugs are unique in that they target the genetic material in the nucleus of a cancer cell,” said Robert Forgey, ProNAi founder and president. “The interaction of our drugs with the target gene results in cancer cell death.” In preclinical animal studies the company’s therapy has successfully eliminated drug resistant tumors in mice.

ProNAi Therapeutics is currently focused on one agent that targets a specific gene sequence. The company received approval from the U.S. Food and Drug Administration’s Oncology Division to conduct human trials and has begun a clinical study at a cancer research center in Texas. The Phase 1 clinical trial will test the drug on patients with advanced solid tumors that have failed to respond to all approved therapies. The ProNAi team believes its anti-cancer agent is promising for the treatment of patients with many solid and hematological cancers, such as lymphoma, breast, prostate, lung and ovarian cancers and melanoma. The FDA proscribes the development pathway for drug testing and ProNAi’s trial to prove the safety and tolerance of their drug is a three-phase process.

“We expect that within five years we will have completed the testing of our drug alone and then in combination with other treatments,” says Forgey. “So far, we?ve been very pleased with the results when combining our drug with other therapies and believe that when the efficacy studies are finished the outcome for cancer patients will be distinctly positive.”

Forgey has taken ProNAi’s technology from an academic concept through an R&D stage to what is now a virtual clinical development company with a focus on manufacturing the drug and dosing patients.

“We are now using a small number of direct and contract employees to run the operation and have teams at a contract research organization and at a drug manufacturing facility,” said Forgey. “In five or six years, however, we?d like to again start up lab drug discovery operations here in Kalamazoo and bring other cancer fighting drugs forward.”

Moving into human trials is a significant and impressive statement for a small life sciences company. The outcome of the human trials will not only determine the potential for the drug, it will determine whether ProNAi will retain the ability to capitalize future drug development.

Since its launch in 2004, ProNAi has raised $17 million.

“We have been so fortunate to have the support of a group of investors from the Michigan area who share our view of the enormous potential of ProNAi’s therapeutic approach,” says Forgey. “Getting to the point of human trials would never have been possible without the Michigan Economic Development Corporation (MEDC).”

ProNAi received early-stage funding through the 21st Century Jobs Fund, the state’s initiative administered by the MEDC and designed to reshape and diversify Michigan?s economy by sparking new investment that will create high-tech companies and jobs.

“But it was the MEDC’s Follow-on Fund investment that cemented a true public-private partnership that includes the state and venture capital and angel investment communities that bridged the capital gap and allowed ProNAi to move forward.”

ProNAi has aggressively sought out other public sector service providers in the course of building the business and the Michigan Small Business Technology Development Center (SBTDC) has been a key element in the success achieved to date.

“From the outset, we have worked with various members of the SBTDC network beginning with help developing a business plan,” Forgey says. “I actually consider them part of the ProNAi team, and a partner involved with setting our strategic direction, looking for financial opportunities, and generally giving us solid business counsel. Any company would be smart to take advantage of their knowledge.”

ProNAi is a concrete example of the state’s efforts to encourage the development and commercialization of competitive edge technologies.

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