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Safety of BRCX001 Cannabidiol formula in patients under Standard of Care (SOC) chemotherapy regiments.

Safety of BRCX001 Cannabidiol formula in patients under Standard of Care (SOC) chemotherapy regiments.

RESEARCH ARTICLE                                         STATUS                                                             08/04/2018                                    

Sarah F. Katta D.O.                                        For Public Release                                                Link to PDF                                               

Philip Arlen, PhD

                                                                                                                                               

ABSTRACT

 

Background: Safety of Cannabinoids has been well established in clinical trials. [GW Pharma] They have also been shown to cause antitumor effects by various mechanisms by inducing cell death, inhibiting tumor angiogenesis, and inhibiting cell growth. BRCX001 is a specific cannabinoid formula that has been used in cancer patients to help with quality of life, sleep, bowel movements, appetite stimulation, and insomnia.

Methods: 30 patients with various malignancies at Southwest Cancer Center located at 922 Lucerne Terrace Orlando, FL 32806, voluntarily utilized BRCX001 cannabinoid formula in combination with standard of care chemotherapy. Safety data using heart rate, blood pressure, body temperature, hematologic parameters, chemistries, kidney and liver function tests were assessed at each patient visit.

Findings: BRCX001 did not affect heart rate, blood pressure and body temperature, hemoglobin, hematocrit, platelet, renal or liver functions. Patient Reported Outcome included feeling more stable and were more able to adhere to their chemotherapy schedules, were less nauseated, had better sleep and had less pain compared to before using the formula.

Conclusion: Overall, BRCX001 cannabinoid formula is associated with few side effects and toxicities and did not affect labs in a negative manner. Thus, BRCX001 Cannabinoid formula is well suited for use in conjunction with standard of care chemotherapy for common chemotherapy adverse effects.

 

INTRODUCTION

There are over 140 different cannabinoids found in the plant gene Cannabis Sativa L. The most widely recognized cannabonoid in Cannabis is ∆9 Tetrahydrocannabinol which is a controlled substance and requires DEA approval for testing.

The other Cannabinoids in high concentration in Cannabis Sativa L are Cannabidiol (better known as CBD) and Cannabigerol (CBG). These extracts have no psychoactivity and are not DEA controlled when extracted from Industrial Hemp plants that are compliant with Section 7606 of the Farm Bill. The presence or absence of THC is generally considered the specific factor that defines cannabis plants as marijuana (>0.3% THC) or industrial hemp (<0.3% THC). DEA classifies “Industrial Hemp” as any plant containing less than .3% ∆9 Tetrahydrocannabinol, by dry weight.

Safe use of cannabinoids in humans has been suspected for quite some time. Lack of true scientific studies and looming regulations have hampered efforts to test the most popular cannabinoid, Tetrahydrocannabinol (THC.) With the newly emerging consumer market for Federally compliant hemp derived Cannabinoids becoming more relevant, the opportunity to test these products for use has become available.

The almost immeasurable amount of new hemp products emerging into the marketplace on a daily basis, presents clinicians with a unique a challenge of determining which products are in-fact unique and present a valuable opportunity to practitioners. Without FDA approval, lack of regulated standards or Continuing Education Credits being issued by relevant physician associations, challenging decisions are mostly left to desperate patients who seek access to promising new treatments before succumbing to a life-ending disease.

The vast amount of credible, knowledgeable research establishing cannabinoids as a significant mitigating treatment option for many indications is undeniable. Giving patients new options where no other options have existed before brings not only hope but also generates viable data for companies to further develop truly life-saving products to further present to the FDA for review.

 

METHODS

Initially, 30 patients receiving Standard Of Care (SOC) at Southwest Cancer Center voluntarily elected to add BRCX001 to their treatment and were receiving BRCX001 in addition to their SOC in order to improve their quality of life, helping with appetite and sleep.

Oncologists at Southwest Cancer Center noticed these thirty patients who were regimented to BRCX001, were experiencing significant differences in response rates when compared to patients who have not included BRCX001 in their standard of care treatment. Investigators decided to closely track any subsequent patients who elected to add BRCX001 to their SOC regiment. The monitoring of patients utilizing BRCX001 still continues in order to gather relevant data.

Chemotherapy administered at Southwest Cancer Center is per NCCN guidelines (National Comprehensive Cancer Institute) and is standard of care.

Listed chemotherapy drug regiments used with above patients were the following for the respective indications:

 

  • Cholangiocarcinoma patients: Treated with FOLFINOX (5FU 400 mg/m2 IV D1, followed by 2400 mg/m2 over 46 hours, oxaliplatin 85 mg/m2 IV D1, leucovorin 400 mg/m2 IV day 1, irinotecan 180 mg.m2 IV day 1. every 2 weeks. This was followed by Neulasta 6 mg SC 24 hours post chemotherapy.

 

  • Pancreatic cancer patients: Treated with Gemcitabine 1000 mg/m2 IV D1, 8, 15 IV plus or minus Abraxane

 

  • Colon cancer patients: Treated with FOLFOX and Avastin (5FU 400 mg/m2 IV D1, followed by 2400 mg/m2 IV over 46 hours, leucovorin 400 mg/m2 IV day 1, oxaliplatin 85 mg/m2 IV day 1) every 2 weeks

 

  • Multiple myeloma patients: Treated with RVD ( Revlimid 25 mg po D 1-21, Velcade 1.3 mg/m2 SC D1, 4, 8, 11 and Dexamethasone 40 mg weekly) every 3 weeks

  

FINDINGS

Patient Reported Outcome

Patients reported the addition of BRCX001 to their standard of care affected the Adverse Effects* of chemotherapy in the following percentages.

No Adverse Effects Mild Medium Moderate Severe
BEFORE BCRX001 61.04% 5.84% 12.34% 7.79% 12.99%
AFTER BCRX001 68.63% 18.95% 7.19% 3.27% 1.96%

*Subject of Adverse Effects:

Nausea                             Headaches                  Loss of Appetite                               Diarrhea

Visual Issues                  Vomiting                     Stomach Pain                                    Sleep Issues

Anxiety                           Weakness                     Overall Pain

 

Clinician Discovery 1-a Safety Data:

In our Clinician Discovery safety study, thirty (30) patients with various cancers, receiving chemotherapy at Southwest Cancer Center, added BRCX001 to their daily regiments. These patients’ labs were reviewed for 90 days. Labs were reviewed for liver, kidney and blood functions for 30 days prior to, 30 days during and 30 days after daily administration of 100mg of BRCX001 daily. Patient heart rate, blood pressure and body temperature were also measured. No negative effects were shown or reported across all liver, kidney and blood functions.

 

White Cell count [Fig. 1.], Platelets [Fig. 2], Hematocrit [Fig. 3], Hemaglobin [Fig 4.], Creatinine [Fig 5], Billirubin [Fig. 6], AST [Fig 7] and ALT [Fig 8.] were monitored. Patients were receiving chemotherapy treatment for the entire time before, during and after labs were drawn. Blue-scale in the charts indicates normal levels. Labs showed counts were unaffected and within normal levels, notwithstanding chemotherapy regiment.

 

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Fig. 8

 

CONCLUSION

 

BRCX001 cannabinoid formula does not exacerbate adverse effects associated with chemotherapy administration. Coadministration of BRCX001 and the chemotherapy designated above was shown to be safe and well tolerated.

 

This study suggest that BRCX001 is non-toxic in non-transformed cells and does not induce negative changes on food intake, did not induce catalepsy, does not affect physiological parameters (heart rate, blood pressure and body temperature), does not affect gastrointestinal transit and does not alter psychomotor or psychological functions.