It seems to me that the difference between the "historical" incidence rate in the placebo arm and the IPIX results (~75vs60) is such that sample size can't fully explain it, so I dug out the ingoing population criteria to see if it held an explanation....I expected it to. Unfortunately I don't have what it takes to discern which elements might have that effect. But here they are:
Brilacidin Criteria
Inclusion Criteria:
Willing and able to read, understand and sign an informed consent form (ICF)
Have recently diagnosed (within previous 6 months) pathologically confirmed, non-metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx that will be treated with CRT therapy as first line non-surgical treatment. Scans (CT, PET, and/or MRI) obtained within 120 days prior to consent for screening can be used to determine the subject's eligibility.
Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose ≥55 Gy and ≤72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate). [Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria]
Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. However, potential subjects with an ECOG of 3 may be enrolled provided their condition does not preclude performing the actions required by study participation (e.g., opening medication bottles, swishing the oral rinse and spitting out, completing or participating in completion of daily diaries and FACT-H&N forms).
Have adequate hematopoietic, hepatic, and renal function at a screening visit
Urine or serum pregnancy test: negative for female patients of childbearing potential
Agree to utilize medically accepted methods of birth control during study participation and for 90 days following the last treatment with study drug if a female subject is of childbearing potential or if a male subject has an opposite sex partner of child bearing potential.
Males or females aged ≥18 years on day of consent.
Exclusion Criteria:
Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
Has metastatic disease (M1) Stage IV C
Has had prior radiation to the head and neck
Plan to be treated with cetuximab (Erbitux®)
Planned use of cisplatin as induction chemotherapy.
Has a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excised
Has had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for major surgical procedure during the course of the study
Has incompletely healed sites of dental extractions
Has an 12-lead ECG obtained at screening visit which shows medically significant abnormality(ies) (e.g. left bundle branch block, frequent premature ventricular contractions, QTc interval prolongation > 450 msec for males and > 470 msec for females)
Has untreated hypertension or has hypertension under treatment that meets protocol definitions.
Has active infectious disease undergoing systemic treatment excluding oral candidiasis
Has oral mucositis (of any severity) prior to initiation of radiation therapy
Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
Has known seropositivity for HIV or hepatitis C antibody, or known to be hepatitis B surface antigen positive (testing for these serologic markers is not required for enrollment in this protocol)
Use of any investigational agent within 30 days of randomization
Is pregnant or breastfeeding
Has known allergies or intolerance to brilacidin, cisplatin or carboplatin
Has inability to give informed consent or comply with study requirements
Has any other condition or prior therapy that in the opinion of the Investigator would make the patient unsuitable for the study and/or unable to comply with requirements for follow-up visits.
Is unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study period
Soligenix SGX942 Criteria
Inclusion Criteria:
Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
Must be able to read and understand informed consent
Adequate birth control methods for the duration of the study
Exclusion Criteria:
Current mucositis.
Prior radiation to the head and neck.
Chemotherapy treatment within the previous 12 months.
Tumors of the lips, sinuses, salivary glands or nasopharynx.
Unknown primary tumor.
Stage 4c metastases.
Evidence of significant hepatic, hematologic, or immunologic disease.
Women who are pregnant or breast-feeding.
But can it core A apple?
Yes Ralph, of course it can core A apple.
AI
