Creative BioTherapeutics
Creative BioTherapeutics

Several breakthroughs have been made in medicine, with continuous innovations researched and conducted by scientists. Yet, drug-resistant diseases remain a silent epidemic, claiming millions of lives every year.

It's a crisis that seems impossible to escape. Nearly one in eight women in the U.S. will be diagnosed with invasive breast cancer, and one in 43 will die from it. In fact, cancer deaths are responsible for over 10 million fatalities worldwide each year, with Metastatic Breast Cancer (MBC) continuing to be the leading cause of death among women despite advances in early detection and treatment. Furthermore, Alzheimer's disease, which now affects 6.9 million Americans over the age of 65, threatens to double by 2060 unless breakthroughs are discovered. These diseases, resistant to current treatments, demand immediate attention and innovation. Without viable solutions, the human cost will only rise.

In this critical moment, two individuals stand on the cusp of a potential breakthrough that could change the course of drug-resistant diseases: Anita and Dr. Donald 'Don' Davidson, the co-founders of Creative BioTherapeutics LLC (CBT). Their work, founded on Dr. Don's decades-long research, has brought to light an innovative solution: CBT300, a first-in-class biologic therapy designed to strip away the protective layers that make cancer cells, viruses, and even neurodegenerative diseases so resistant to treatment.

This growing prevalence of diseases that evade current treatments is alarming. In the cancer realm, particularly in metastatic forms like MBC, survival rates are grim, with patients often surviving only months rather than years. Many times, traditional treatments like chemotherapy are becoming ineffective due to the development of drug resistance in tumor cells. Alzheimer's, similarly, is progressing rapidly, with no cure or effective treatment in sight for the millions suffering from cognitive decline.

At the heart of these challenges lies a stress protein called GRP78. Discovered on the surface of diseased cells by Dr. Don over three decades ago, this protein acts as a protective shield on the surface of diseased cells, enabling them to evade the immune system and resist drugs. It essentially serves as a 'survival coat,' making cancer cells immune to chemotherapy and other treatments. This discovery was a pivotal moment, revealing a mechanism behind drug resistance that had long been a mystery to the medical community.

CBT300 works by targeting this very protein, effectively stripping away the survival coat that enables cancer cells to resist treatment. By removing this protective layer, CBT300 not only exposes the tumor to the immune system but also makes the environment inhospitable for the cancer cells, often leading to their regression. In preclinical trials, CBT300 has demonstrated a remarkable ability to eradicate drug-resistant tumors without causing the toxicity typically associated with chemotherapy. In some cases, CBT300 has even been shown to work in combination with lower doses of chemotherapy, enhancing the overall efficacy while minimizing harmful side effects.

But that's just the beginning. The broader implications of CBT300 extend to diseases beyond cancer. The same GRP78 protein is implicated in Alzheimer's disease, where it contributes to the formation of plaques that damage brain cells. Moreover, the protein also plays a role in viral infections, such as COVID-19, by facilitating the entry of the virus into cells. The versatility of CBT300 positions it as a potential treatment for several deadly and previously untreatable diseases.

While the results thus far are promising, there's still much work to be done. CBT is currently in the preclinical phase and needs significant funding to proceed with the next steps, such as the toxicity studies and regulatory filings with the FDA to begin Phase 1 clinical trials. This crucial funding will help CBT scale up production and refine the drug to meet Good Manufacturing Practice (GMP) standards. The goal is to file for the FDA's Investigational New Drug (IND) approval and begin human clinical trials by the first quarter of 2026.

Anita, who brings 40 years of healthcare experience to the team, is passionate about accelerating this process. As a physical therapist and business owner, she understands the real-world impact of drug-resistant diseases all too well. "I've lost too many patients over the years, and every day without this treatment means more lives are at risk," says Anita. "I know that this drug could have helped them. I know that this could be the answer for so many people out there."

Creative BioTherapeutics is poised to lead the way, but it needs the support of investors, healthcare advocates, and the global community to make its vision a reality. With the right resources, CBT300 could soon become the breakthrough that so many patients are desperately waiting for.

With a determination that leaves no doubt about the potential impact of their work, the co-founders conclude, "We are going to make this happen. We have to."