PixarBio Corporation is combining FDA-approved biomaterials with FDA-approved drugs to enable the controlled release of therapeutic drugs.
“Our product development begins with clinical need and explores a wide range of FDA-approved drugs and materials. Through local drug delivery systems we can optimize therapeutic effect while minimizing side effects,” Frank Reynolds, CEO, PixarBio Corporation, said. PixarBio’s NeuroRelease platform enables tightly targeted and controlled drug release. “Drug release can be controlled, so that it can be started or stopped as needed,” Reynolds said.“We are developing it for pain treatment, as well as for epilepsy, spinal cord injury and Parkinson’s disease. Additional applications in cancer and dentistry are on the horizon. In all forms, NeuroRelease takes effect within minutes, and release has been optimized for 3, 5, 7, 10, 14 and 21-day post-op pain treatments.”
Frank Reynolds, CEO, PixarBio Corporation
Traditional drug delivery is inadequate
Pills have been adequate to deliver small molecule drugs, but biologics and other large molecules can’t be delivered that way. They deform in the body and, for timed release, are too large to travel through traditional polymers. To solve such problems, Reynolds works closely with PixarBio co-founder and scientific adviser Robert Langer, Sc.D., who was just awarded the Queen Elizabeth Prize for Engineering and is one of only 11 Institute Professors at the Massachusetts Institute of Technology (MIT). Dr. Langer approaches drug delivery problems by using FDA-approved polymers to support the molecule delivery at predetermined rates.
“At the nanoscale, properties change,” Reynolds pointed out. For diseases like Parkinson’s, nanoscale particles will be key in developing drug release systems. However, for NeuroRelease pain treatment, PixarBio combines micro-scale materials with patent-pending formulations of FDA-approved drugs making it possible to inject microparticles that block pain for months while measuring one one-thousandth of an oral dosage. These delivery systems are considered smart materials. “It’s one thing to develop smart materials but another to optimize them under cGMP,” Reynolds said.
“We’ve learned to control them and manufacturer them and then scale the products to a range of neurological conditions.”
Goal: Morphine replacement
One of Reynolds’ goals is to replace morphine and other opioids and narcotics as post-operative pain treatments. “There are 70 million surgeries in the US that need post-surgical pain relief. Opioids such as morphine, Percocet (oxycodone/paracetamol) and Vicodin (hydrocodone/paracetamol) are standard post-op treatments, but there are a lot of challenges around opiates in our society, especially around addiction.”
He noted that in 2010 the FDA removed Darvocet (propoxyphene/acetaminophen) after a couple of decades of FDA approval. In January of 2014, the FDA reduced the amount of acetaminophen in both Percocet and Vicodin with suggestions of future modifications to further reduce opiate intake. In contrast, PixarBio’s compound, NeuroRelease Pain, blocks pain, is non-addictive, non-toxic and doesn’t affect locomotion, Reynolds said. The company is developing optimized models of an FDA-approved drug to enable pain relief for up to six months.
“Our first human study is a 14-day post-op pain treatment for knee replacement,” he said. “Pain treatment is very simple for us,” Reynolds said. It’s just a matter of preventing the pain signal from reaching the brain. “NeuroRelease Pain shuts down signaling for as long as the drug is present. NeuroRelease will be used as a femoral nerve block for knee pain. For hip pain, it can be injected in the lumbar plexus.”
The microparticle doesn’t alter the standard of care and can last as long as six months before biodegrading.
Orphan drug filing
PixarBio just filed an orphan drug application for the NeuroRelease platform in trigeminal neuralgia. “Trigeminal neuralgia is the number one side effect of stroke. We can inject a 90-day treatment, but our platform also enables a six-month therapy,” Reynolds said. “We built the platform for indications that affect many people, and we’re lucky that it also helps orphan diseases.”
Designation as an orphan drug would allow PixarBio a seven-year market exclusivity in the United States, along with research tax credits, the ability to apply for grants, substantial FDA assistance for clinical trial design and drug development, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees, all of which help advance the filing of an Investigational New Drug (IND) Application for the NeuroRelease platform.
Partnering for additional indications
PixarBio is considering partnering to develop the platform for other indications, including epilepsy and Parkinson’s disease.
NeuroRelease Epilepsy is devoted to delivering the right drug at the right time, to help patients avoid seizures and side effects, Reynolds said. “Nobody has ever injected, implanted or otherwise released any anti-epilepsy drug that lasted for more than two days. Our current implant has released for over 450 days and we expect it last five years.” Likewise, PixarBio’s drug for Parkinson’s disease delivers Dopamine, a drug developed in the early 1960s, directly to the brain. But, thanks to nanomaterials, the new formulation passes through the blood brain barrier to deliver the drug directly to the target.
“A dentistry application also is in development to replace Novocain (procaine),” Reynolds said.
Reynolds’ personal experience
Reynolds’ obsession with pain, paralysis and Parkinson’s disease mirrors his own family history. Paralyzed in a surgical accident in 1992, he spent years bedridden and, later, in a back brace, determined to find a way to walk again. He now is fully mobile. His research also has benefited his daughter, who became paralyzed a few years ago, and his father, who developed Parkinson’s disease. Since his paralysis 22 years ago, he has earned six Masters degrees: engineering (University of Pennsylvania), business administration (MIT – Sloan), technology management (University of Pennsylvania – Wharton), management information systems (Temple University), health administration (St. Joseph’s University), and counseling psychology (Chestnut Hill College). “I invented the Neuroscaffold for spinal cord injury (while CEO at InVivo Therapeutics, which he founded in 2005) and cured paralysis,” he said. “At In Vivo, 14 of 17 trials worked in animals on the first try.”
InVivo reports that in January 2015, 90 days after implantation of the first patient, that person had regained bowel, bladder and hip muscle control, with no adverse events. At 12 months, motor function was returning around the ankle. Here at PixarBio, which he co-founded after retiring from InVivo, Reynolds said his success record is 18 of 18. “I’m the only one to get every rat, monkey and human walking on the first try.”
Commercialization in 2017
The challenges for PixarBio, Reynolds said, aren’t scientific. He recently met with the FDA and predicts the company will have about a dozen FDA-approved labels by 2020. The first will be pain therapy for knee replacement surgery in late 2017. Nerve block studies for hip and shoulder pain are anticipated to be approved by the FDA shortly afterward. PixarBio plans to go public in 2016. “Our stock symbol has been reserved, paperwork is in process and we will begin public trading in January 2016.”
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