Quest for Pancreatic Cancer Cure Leads to Flavocure - 36 year old man with stage IV pancreatic cancer seeks "Right to Try"
A Wisconsin and Illinois family are fighting for the life of Robert Colon, a beloved husband, father, brother, son, and nephew. Robert has cancer of the pancreas and is in the final stages of the disease’s rapid progression. But the family is not giving up and is calling on Washington DC with their pleas for Robert’s “Right to Try."
“With the current administration’s efforts to allow for rapid approval of 'Right to Try,' we can only hope it happens in time for Robert,” states Debra Lopez, aunt.
For reasons oncologists are only beginning to understand, pancreatic cancer is particularly lethal. Within five years of the diagnosis, more than 93% of patients will die from the disease. It resists most standard therapies, including surgery, chemotherapy, radiation therapy, immunotherapy, and targeted therapy. This type of cancer metastasizes quickly, often before the person has even been diagnosed. Many patients are told they already have Stage IV cancer at their first appointment with an oncologist.
But until now, pancreatic cancer hadn’t met the Lopez/Colon family! As soon as Robert, just 35, was diagnosed, the cancer had already metastasized to the liver and surgery wasn’t an option thus, he was given the standard chemotherapy for pancreatic cancer called the “big guns,” Folfirinox which stabilized his cancer long enough for him to try a clinical trial. Therefore, the battle began - his loved ones started to do extensive research on other treatments and a potential cure.
A family member found a clinical trial at the Pennsylvania Cancer Center, targeting his specific gene mutation. Thankfully, it worked for several months and slowed the tumor growth, giving him more time with his young family. However, the cancer began to resist the treatment and started to progress once again. Robert’s cancer was fighting back.
So Robert went back on traditional chemotherapy. This time it was Gemcitabine and Abraxane. Within a few months, however, he was told by his oncologist that it wasn’t working – and that he should go home and spend the rest of his time with his wife and children.
Flavocure Biotech and FBL-03G
Once again, the search was on for another, potentially better therapy. This time, the family found Flavocure Biotech.
Researchers from Harvard University’s Dana-Farber Cancer Institute found a potential pancreatic cancer treatment through a surprising source: a chemical discovered by Dr. Henry Lowe and found in cannabis.
According to the recent study, FBL-03G demonstrates significant potential in the treatment of cancer of the pancreas with a new non-cannabinoid, non-psychoactive derivative of cannabis, termed FBL-03G. The test findings illustrate the potential in the treatment of both localized and advanced pancreatic cancer, justifying further studies toward clinical translation.
Flavocure announced the investment in their readiness studies (preclinical trials) more than a year ago. Critically important, independent financial commitments are paving the way for Flavocure to attain IND (investigator new drug) status from the FDA (which will allow them to proceed with clinical trials). The first set of trials was expected to be complete by the end of 2019. Flavocure hired a reputable clinical research organization (CRO) to conduct the studies.
Because Clark L. Swanson, Co-Founder and Executive Vice Chairman of Flavocure Biotech , believes so strongly in this potential treatment, he independently sponsored the initial study cost with an investment of $1 million of his own. However, the research team says that, for the time being, "patients will need some patience."
In a telephone interview with a representative of Debra Lopez Public Relations, Mr. Swanson went on to talk about his optimism for this lead drug candidate, and his claim that being smart isn’t everything – you have to be lucky too. He said,
“Consider what Nixon, Reagan and Trump have all contributed to the development of Flavocure’s drug? These contributions to American history may have culminated into us being able to capitalize at being in the right place, right time - now. Nixon made cannabis a Schedule I drug, which are deemed to have no medical use and a high potential for abuse. As a result, cannabis was never fully exploited for its medicinal qualities, effectively 'freezing' this opportunity until now. Reagan, in 1983, enacted the Orphan Drug Act which allows us priority and other assistance from the FDA, and allowed small drug companies like ours, the framework to develop drugs for orphan indications. And finally, Trump enacted the 'Right to Try' which will give potentially hundreds or thousands of persons with pancreatic cancer the opportunity to take caflanone.”
Clark L. Swanson's latest Interview on Flavocure and FBL-03G
What’s the Holdup?
Flavocure Biotech already has Orphan status by the FDA but is waiting for approval from them to start their Phase I of the clinical trial. Flavocure had expected to begin their clinical trials by May, 2020, but it now looks like they will begin in June of 2020 at the earliest.
But that’s not good enough for the Lopez/Colon family. They’re trying to save Robert’s life, and they want him to take part in these clinical trials as soon as possible. Two months is too long. So, the Lopez/Colon family is hoping to enact the “Right to Try” Act for Robert before the completion of the Phase 1 clinical trials.
Right to Try
On May 30, 2018, President Donald Trump signed S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act. This law is a way for patients who have been diagnosed with life-threatening diseases or conditions - who have tried all approved treatment options and who are unable to participate in a clinical trial - to access certain unapproved treatments.
Clinical trials provide information about whether a product is safe to use and can effectively treat or prevent a disease. Patients have many reasons for participating in clinical trials. In addition to contributing to medical knowledge, some participate in clinical trials because there is no treatment for their disease, treatments they tried have not worked, or they are not able to tolerate the current therapies.
If Robert cannot be enrolled as part of Flavocure Biotech’s clinical trials with FBL-03G , he needs to still have access to the drug if there is a chance for him to respond to treatment before it’s too late. He’s got nothing to lose and everything to gain. But he needs to be enrolled in the trial, but there will only be an estimated 20 seats available, but potentially thousands of applicants. Under a pre-emptive Right to Try, given the safety profile of caflanone, Robert should be allowed to access this potentially life-saving drug.
Before It’s Too Late
So the Lopez/Colon family is contacting everyone they can - the President, Senators, members of Congress, the FDA, and the media - to get the trials underway. They are hoping and praying Flavocure can get FDA approval in time to help Robert and all other pancreatic cancer patients before it's too late.