In a perfect world, medical researchers could take all the time they needed to develop new drugs. Some can. However, the team behind biotech company NeOnc faces a unique kind of time pressure: The faster they can get new developments to market, the more lives they may be able to save.
Historically, many types of brain cancer (particularly glioblastoma) have proven difficult to treat, primarily because the blood-brain barrier prevents most cancer drugs from getting at the cancer itself.
“There are about 22,000 new cases per year of primary brain cancer in the United States,” says Dr. Thomas Chen, NeOnc’s founder and a preeminent neurosurgeon. ”It’s a disease where we haven’t had any significant improvement in survival time. Patients with glioblastoma, the most aggressive of the primary brain cancers, still only live an estimated 15 to 18 months. We’ve even had public figures such as Beau Biden, Ted Kenney, and John McCain diagnosed with it. They had the best care that we can give them and they still passed away.”
Dr. Chen has dedicated much of his life to treating aggressive forms of brain cancer. Now, he’s developing something he calls a “nasal-brain delivery system” for brain cancer drugs – patients would inhale brain cancer medication and aerosolized molecules of the drug would bypass the blood-brain barrier.
The Food and Drug Administration (FDA) requires that all drugs pass through a rigorous series of trials before making it to market. Testing is a necessary part of ensuring that drugs are safe, non-toxic, and effective. But what happens if a medication currently going through clinical trials is a patient’s only hope of survival?
In that case, the FDA has a “Fast Track” designation. This expedited testing and approval process is designed for drugs that fill an urgent, unmet medical need.
That designation means NeOnc may be able to help more patients in the near future. However, Dr. Chen and the rest of the NeOnc team are also making an effort to help patients who are running out of time in their current trials.
“It’s not like we’re conducting a double-blind test,” explains NeOnc Executive Chairman Amir F. Heshmatpour. “These are people who are out of options and running out of time.”
Heshmatpour emphasizes that the trials are focused on the most aggressive brain cancers—those with the highest malignancy grades. Initially, NeOnc’s clinical trials targeted only Grade 4 tumors, the most dangerous and difficult to treat. However, recognizing the life-saving potential of the nasal-brain delivery system, Dr. Chen took the initiative to expand eligibility.
“Dr. Chen approached the FDA and requested permission to enroll Grade 3 patients as well”, says Heshmatpour. Once approved, NeOnc hopes to be able to help even more people.
For patients seeking to participate in these trials, time is critical. Those enrolled aren’t just battling highly malignant tumors; they’ve exhausted every conventional treatment option.
“We select patients who are what we call ‘recurrent’,” explains Dr. Chen. “They’ve already undergone standard care, including surgery, radiation, and chemotherapy. When those treatments fail, their survival time is typically just six months.”
Heshmatpour and the NeOnc team are committed to making this treatment widely accessible as quickly as possible. As clinical trials are completed, regulatory approval will be the next goal.
“Once we complete Phase 2A of clinical trials, we plan to proceed with Phase 2B, involving about 60 patients,” says Heshmatpour. “That is the next step towards eventual market approval.”
“The impact of this technology could be far-reaching,” says Heshmatpour. “At NeOnc, we’re not just developing new treatments—we’re focused on changing the way life-threatening brain diseases are fought.”
Healthcare disclaimer:
This article is for informational purposes only and does not substitute for professional medical advice. If you are seeking medical advice, diagnosis or treatment, please consult a medical professional or healthcare provider.
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