Gold In September (G9)Funding Helps Develop Breakthrough Cancer Therapy

DELAFIELD, WI–Gold In September®(G9) is pleased to announce that Naxitamab (Hu3F8), a treatment for high-risk pediatric neuroblastoma the organization helped fund, recently received Breakthrough Therapy Designation from the FDA.

According to the FDA, “Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

The quest forHu3F8 to receive this designation started in 2007 with a small group of parents at a Ronald McDonald House in New York City.Sarah Bartosz, President of G9, and her husband John were among that group. Sarah and John were fighting to find a cure for their son, Jack, who was battling neuroblastoma.“Each parent in the room that day had one thing in common. We all had a child with relapsed neuroblastoma and no treatment options.We were desperately seeking hope…searching for something that could help our children. WhenDr. Cheung presented his research and thoughts behind the therapy, we collectively asked ‘how do we get it to market,’” Bartosz recalls.One million dollars was the magic number for the initial funding.

“That day was pivotal for our family and marked the beginning of what is now G9,” Bartosz notes. It took two years to raise $1M, but the small group worked together, and with their own organizations,to fundraise. In 2009 funding was delivered.

Despite the hope that this designation gives for many parents looking for a cure, it came too late for Bartosz’s son, Jack. However, she remains resolute in the battle.“Though I cannot save my own child, I choose to fight. Because fighting means that I can save another parent from feeling hopeless and, instead, assure them there is great and abundant hope.This Breakthrough Therapy, and others just like it, sitting in labs waiting for funding, are why G9 exists…why we work tirelessly to raise awareness and funding for childhood cancer treatments,” Bartosz reflects.

Throughout the holiday season, G9 is seeking to raise $50,000 towards funding other childhood cancer therapies. “Science and technology are poised with novel therapies and personalized, precision medicine that will allow doctors to treat childhood cancer with a laser-guided bullet to minimize both short and long-term side effects and consequences,”Bartosz urges.

With this understanding comes G9’surgency to support research efforts. “It is because of this great need that G9 is dedicated to growing awareness for childhood cancer so that people will take action and help fund the next generation of treatments, a generation of cures. Because where there is awareness, there is obligation to be part of the solution,”Bartosz concludes.

About Gold In September®(G9)G9 is a childhood cancer non-profit dedicated to increasing funding for childhood cancer research and initiatives by growing awareness that inspires action to help every child, everywhere. G9 directly funds Early Phase Trials, bringing the newest, most promising treatments to kids faster. Utilizing a noble model of turning the world gold to raise awareness and meet the mission, G9 directly benefits the entire childhood cancer community with gold alliance, resulting in increased funding and support for all childhood cancer initiatives.For more information about Gold In September® visit www.goldinseptember.com.

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