Cannabis Derivative FBL-03G Represents Significant Therapy Potential to Treat Pancreatic Cancer

Aug 21, 2019 | Cannabis, Flavonoid Derivative, Oncology, Pancreatic Cancer

Cannabis Derivative FBL-03G Represents Significant Therapy Potential to Treat Pancreatic Cancer

Researchers from Harvard University’s Dana-Farber Cancer Institute are in pursuit of pancreatic cancer therapies through a surprising source: a chemical found in cannabis.  According to the recent study, FBL-03G demonstrates significantly therapy potential in treatment of pancreatic cancer. Enter Flavocure Biotech.

The Problem

Pancreatic cancer is deadly. Making up 3% of all cancers in America it has a one-year survival rate of just 20% (5 -year survival rate of less than 8). The Pancreatic Cancer Action Network predicts it will be America’s second leading cause of cancer-related death by 2020. There is no cure.

Harvard/Flavocure Biotech Research

In a recent study published the Journal Frontiers of Oncology, the team found that the flavonoid derivative of cannabis demonstrates significant therapy potential in the treatment of pancreatic cancer, including radio-sensitizing and cancer metastasis treatment potential. The results justify further studies, the researchers declared, to optimize therapy outcomes toward clinical translation.

Harvard’s Dana-Farber has been a key catalyst as they decided to take the therapeutic potential of FBL-03G and test it against pancreatic cancer via a lab experiment. The key researcher there is Wilfred Ngwa, PhD.

What is FBL-03G

Produced by Flavocure Biotech, FBL-03G represents an exciting collaboration with Harvard Medical School. The results of the FBL-03G molecule have shown statistically significant results against Pancreatic cancer in vivo. The company plans to continue their collaboration with Harvard to advance FBL-03G towards an improved treatment and a cure for pancreatic cancer.

FBL-03G has exhibited promise against glioblastoma, a deadly form of brain cancer and other solid tumors. Flavocure seeks additional funding to pursue glioblastoma. The company expects that FBL-035 will be their second FDA designated Orphan Drug.  Under the Orphan Drug Act, the designation/approval by the FDA would grant Flavocure benefit of FDA/EMA sanctioned exclusivity on the drug for 7 years in the U.S. and 10 years in Europe in addition to any patent protections.

The drug is derived from cannabis flavonoids which make up just 0.14% of the plant. A challenge as researchers would need many fields of plants. However, this challenge was recently overcome as scientists have found a way to genetically engineer cannabis flavonoids—now making it feasible to investigate their benefits.

Flavocure Biotech 

Based in Baltimore, they were formed in 2018 to discover and develop cannabis derived molecules. They formed a partnership with Harvard and attracted $1.5 million from one of Asia’s richest tycoons via the Denning Growth Fund (DGF).

IND Readiness Studies

Flavocure announced investment in IND readiness studies (e.g. preclinical) at the beginning of 2019. The initial study cost is expected to be over $1 million and has been independently sponsored by the Flavocure’s Executive Vice Chairman, Clark Swanson. These independent financial commitments, critically important, are paving the way for Flavocure to attain IND status from the FDA (which of course would allow them to proceed with clinical trials). The effort was expected to be completed by end of 2019.  Flavocure hired a reputable clinical research organization (CRO) to conduct the preclinical studies.

The Potential Market

Flavocure estimates that the FBL-03G molecule targets a patient market growing at 8.1% CAGR and represents over $2.5 billion annually based on the therapeutic target and implicated cancers.

Lead Research/Investigator

Wilfred Ngwa, MS, PhD, Assistant Professor, Radiation Oncology, Harvard Medical School

40 Comments

  1. ed

    how can we obtain information on how to be connected to the medicationand be apart of the clinocal studies for pancreatic cancer

    • TrialSite

      Hello- Thank you for reaching out. We will send you a direct email.

    • TrialSite

      Hello Ed,
      We were unable to send a DM as the email provided bounced. It is good to hear from you. Presently they are in preclinical (e.g not ready for people) but they are moving toward clinicals. We have your information and can alert you as they file an investigator new drug application (IND) which means they are applying with the FDA to conduct clinical trials. We can also connect you with the company involved Flavocure. We recommend you sign up for the newsletter for any alerts.

      Let us know what works best for you.
      Regards,
      Publisher

      • Grace Mercovich

        Where do we sign up?

        • TrialSite

          An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

    • Marilyn shaffer

      I have recently been diagnosed with a tumor on my pancreas in January of 2020. I am due for an endoscopic ultrasound biopsy in February on the 14th 2020. I fully expect the biopsy to be positive or cancer. I would be interested in participating in any trials as I do not intend to have any kind of chemotherapy treatment. I would appreciate any information on a timeline for any clinical trials involving the use of the cannabis flavonoids it is currently being researched as a treatment.

      • TrialSite

        An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  2. Jean Heinith

    Our friend has metastatic pancreatic cancer and he’s very interested in any type of information regarding the clinicals.

    • TrialSite

      We are awaiting news as to when this group will file an Investigator New Drug Application (IND). It is only after approval of IND will clinical trials commence. In April the sponsor did receive a $1.5 million from an Asian investor as well. But in the world of clinical trials this is not a lot. We will notify our network as soon as we find out more.

    • Grace Mercovich

      I have had pancreatic cancer fr 5 1/2 years
      I am very interested in the trial… could you add me to your newsletter?

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  3. Joseph A Rattner

    Very interested in being part of this trial. In August 2019 I received the diagnosis that I have stage 4 pancreatic cancer. I have been receiving chemotherapy and all of my tumors have shrunk with no further metastasis. So for the moment I have won the battle but know in time I will lose the war. FBL-03G offers some hope. Not expecting a cure but perhaps this could extend my life. Given my diagnosis I am in good health and have a positive outlook .
    Willing to partake anytime and anyplace
    Thanks,
    Joe

    • TrialSite

      We are awaiting news as to when this group will file an Investigator New Drug Application (IND). It is only after approval of IND will clinical trials commence. In April the sponsor did receive a $1.5 million from an Asian investor as well. But in the world of clinical trials this is not a lot. We will notify our network as soon as we find out more.

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  4. Marilyn Shah

    Hello, I live in the UK and have been following this research with great interest, having been diagnosed with ampullary cancer in May this year. Following surgery I am well and currently do not have secondaries, though I know this is very likely in the future.
    Will the forthcoming trials include this type of rare pancreatic cancer, and will all research take place in the US?
    With many thanks,
    Marilyn

    • TrialSite

      We are awaiting news as to when this group will file an Investigator New Drug Application (IND). It is only after approval of IND will clinical trials commence. In April the sponsor did receive a $1.5 million from an Asian investor as well. But in the world of clinical trials this is not a lot. We will notify our network as soon as we find out more.

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  5. Pablo

    My mother has been diagnosed with bile duct cancer liver metastatic cancer, is this fbl-03g also an option for her type of pathology? would she be a candidate for this type of medication?

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  6. TrialSite

    We are awaiting news as to when this group will file an Investigator New Drug Application (IND). It is only after approval of IND will clinical trials commence. In April the sponsor did receive a $1.5 million from an Asian investor as well. But in the world of clinical trials this is not a lot. We will notify our network as soon as we find out more.

  7. Craig Fox

    My wife was diagnosed with stage 4 Pancreatic Cancer on 2/16/18. She has been through 2 rounds of chemotherapy, and has been on only Lynparza for the last 6 months without any progression. We would be very interested in this therapy when it comes to clinical trials. Would you please add us to you email list for any future information

    Thank you

    • TrialSite

      Hello- I am sorry to hear about your wife. We have added you to our newsletter- this sends out all clinical updates nightly. Please let us know if you need anything else.

      • Steven Nagata

        Please.put me on your notification list.

        Thank you.

        • TrialSite

          An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

      • Veronica Freire

        Congratulations and thank you deeply for your commitment to finding a cure to this deadly disease. Please add me to any email updates about clinical trial enrollment and any information pancreatic cancer related. My father was recently diagnosed with pancreatic cancer. We would be honored to be any part of your research and clinical trials.

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  8. Brenda

    Could I please be on a list to be notified of any news for the start of clinical trials? Thank you!

    • TrialSite

      Hello- we send you a private message. Thank you

  9. Kelly Hamula

    Very interested in this clinical trial. I read recruitment taking place in the first quarter of this year with trials set to begin later this spring. My husband has stage 4 pancreatic cancer and is undergoing chemotherapy currently.

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  10. Bill Rath

    My father was diagnosed with pancreatic cancer, had the tumor removed and has been through chemotherapy for a year and recently was informed that chemo was not helping. Would be interested in trying this new finding. Thanks Bill

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  11. Carol Zaslaw

    I desperately want to be part of this study.This is a life and death situation. Please provide me with any information that would allow me to be a part of this study and please add me to the mailing list. Please update me as soon as possible.

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  12. Carol Zaslaw

    I am a surviving pancreatic cancer survivor, having the Whipple almost four years ago. Recently, my CA 19-9 had skyrocket from normal to 235. I want to be in the study. Please advise me how to participate and sign me up for newsletters and any other information that could help save my life.

  13. Sallie Burke

    PLEASE CONTACT ME, MY SON. 49 YRS OLD DIAGNOSED WITH STSHE 3 PANCREATIC CANCER ON DEC. 23RD 2019.ON HIS 3RD CHEMO TREATMENT HIS ANDGENS ARE IN THE 700 RANGE UP FROM 500 RANGE A MONTH AGO. MY # IS 314 210 4077. I HAVE QUESTION ABOUT FLB-036. SALLIE

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

  14. Sallie Burke

    Please call me bout FBl-036. Sallie

  15. Tracy

    We are interested in obtaining information as to how we can be part of this clinical trial. My Mum has recently been diagnosed with Stage 4 Pancreatic Cancer. She is otherwise healthy, positive and a fighter. She is about to start Chemotherapy.

    • TrialSite

      An update this experimental drug is still in the IND phase. The hope is that it will be approved to commence clinical trials and enter into Phase I study by Q2 (April 2020 to June 2020)

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