TOP QUESTIONS WE'VE RECEIVED
Why haven't I heard about PrimoCure Pharma before?
That's clearly an important question. We have all heard the saying that "timing is everything" and that has never been more appropriate than in this response. Though PrimoCure Pharma was established 2012, and has achieved some significant milestones under Dr. Ko's leadership, until all of the pieces of her vision were in place, Dr. Ko felt it was essential to keep the company and its progress behind the scenes. All of these "pharma puzzle" pieces are now fully in place and the time is right to bring PrimoCure Pharma to the forefront to lead the way forward with KAT anticancer therapeutics.
After reading about Dr. Ko's success treating so many cancers, why has this taken so long to get KAT approved and out to the public? What am I missing here?
That is also a really excellent question and one that could take many pages to answer and still not fully describe all of the complexities and issues that have taken place since her discovery of the anticancer effects of 3-BP more than 20 years ago. It is fully understandable that drug development from discovery to FDA approval, or "bench to bedside" takes many years and multi-millions of dollars. The drug approval process is a critical and essential service, and some of these delays are simply the result of living in a complex world with difficult solutions to challenging problems. The FDA is charged with ensuring that drugs and devices that are marketed to us actually provide (at least some of) the benefits that they claim to offer, and do so with a known level of risk and predictable safety. You will find that it may take 15 to 20 years, and from $800M to $3B to complete this entire process for a new pharmaceutical. Dr. Ko's discovery of the benefits and potential of 3-BP for cancer came with some additional complications, which in the beginning took several years to work out, delaying her ability to start an already arduous process. If you're interested to learn more about the history of cancer research and the metabolic cancer theory, one of the best resources I can recommend is a remarkable book by Travis Christofferson called Tripping Over the Truth, which can be found here. Chapter three details much of the history of Otto Warburg's discovery, decades of research by Dr. Pedersen and the discovery and beginnings of 3-BP as an anticancer therapy by Dr. Ko.
What we want to focus on now, however, is the excellent progress that Dr. Ko has made, especially in the last few years, and the positive forward movement that is now taking place with her phase I hepatocellular carcinoma clinical trial which was approved and initiated in partnership with NewG Lab Pharma, Inc. in South Korea. Additionally, the current focus of PrimoCure Pharma, Inc. to initiate a pancreatic cancer clinical trial in 2023 presents a remarkable and promising opportunity for this deadliest of all cancers. We invite you to do your own research to validate the promise of KAT 3-BP, as well as Dr. Ko's complete dedication and commitment of bringing this gift to humanity. You will not find anyone in the field of medical research with more integrity, compassion and commitment to helping relieve the unnecessary suffering of patients. We are excited with the progress we are making at this time and are focused on building upon the current momentum to make KAT 3-BP available to all of those in need as soon as possible.
How can I find out details about the pancreatic clinical trial?
Information on clinical trials may be found at the ClincalTrials.gov website and our pancreatic cancer trial will also be registered and listed here when the final details are put together. We will keep you updated if you leave us your contact information on our website. Additionally, we have made some initial contacts with many of the foundations and organizations that dedicate their research and efforts solely to pancreatic diseases and we will follow up through them as potential partners in our efforts.
When do you expect to start your pancreatic clinical trial and what stages of cancer will be treated?
Understanding that time is of the essence with pancreatic cancer, we hope to start our clinical trial in 2023, and will do all that we can to make that happen. It is a very complex, detailed and expensive process to initiate a clinical trial, but Dr. Ko has made very significant progress and preparations leading up to this time. We have begun seeking grant and other partnership opportunities, but are still in need of key funding to allow us to complete this critical study to validate KAT 3-BP as an effective treatment for pancreatic cancer. Regarding the stages that will be treated, since pancreatic cancer is such an aggressive disease, we anticipate treating any stage, but each case may also depend upon other health factors of an individual patient. All of the details and possible reasons for exclusion from the study will be spelled out when our trial is listed on ClinicalTrials.gov website and we will update that here as well.
Do you have clinical site locations yet?
We're still working on that as well. The clinical site selection process, along with the IRB oversight that has to be in place, is part of a complex process that has to match our study with the institutions who are performing pancreatic cancer research and who recognize that it fits with their needs and focus. This process has started and will determine much about how quickly we can announce the start of our trial and when we can begin.
If I have another type of cancer can my Doctor request KAT for me through the Compassionate Use Program or the Right To Try Act?
This is a great question and one of particular interest to us. It's also a complex question with an equally complex answer. As we've shared previously, Dr. Ko's KAT formulation is very unique in that is has the potential to work effectively to treat most cancer types. Since we can't start clinical trials on every possible cancer type at the same time, one huge benefit of having a clinical trial in place is the possibility of having KAT 3-BP available for what is known as "compassionate use" which is actually part of the FDA's program for Expanded Access Use for drugs and medical devices. Here is a link to the FDA website for some information and basic details about this program. https://www.fda.gov/news-events/public-health-focus/expanded-access/ The sponsor of a clinical trial has the responsibility to determine if, or how, they will address questions from physicians regarding expanded access. We have our policy here along with some essential links and information so you can learn more about the Expanded Access Program, whether you are a patient or a physician, to can determine if it may be appropriate for you to consider.
In 2018, Congress passed the Right to Try Act which was added to the existing FDA Expanded Access Program as another option for patients who have been diagnosed with specific and unique 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 investigational treatment options. The Right to Try Act provides specific guidance to patients and physicians to permit or allow eligible patients to have access to potentially beneficial investigational drugs. The first criteria to determine if a drug is permitted under the Right to Try Act is that an eligible investigational drug must have completed a phase I clinical trial. Additional conditions must also be satisfied, which may be found at this link to the FDA website. To consider the Right to Try option, the FDA recommends that patients first consult with their physician and their physicians should contact the sponsor of the investigational drug or biological product to determine if a request is appropriate.
May I donate to help support the clinical trial?
Donating to Dr. Ko's work is always possible and greatly appreciated. Dr. Ko could not be where she is today, having made the great strides in recent years without the dedication and support of so many who believe in her work and want to see it made available to the public. Right now, the easiest way to support her continued work is through KoDiscovery. Feel free to ask about how to make individual tax deductible donations or use the GoFundMe link to make a contribution of any size, and know that all of your help is greatly appreciated.
Are you still looking for funding? Can I become an investor in PrimoCure Pharma?
We are still in need of funding at this time. Unlike KoDiscovery, which is Dr. Ko's research laboratory and has ownership of her patents and rights to her discoveries, PrimoCure Pharma, Inc. is a Delaware C-Corporation and offers the possibility of a financial investment for those interested in discussing and considering that option. We welcome any potential investors to contact us and our board will follow up to discuss the inquiries and explore those that offer the best promise of meeting the mutual needs of PrimoCure Pharma and each investor. Please use the Contact button below and let us know how to best reach you.