Replies to post #108703 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

Okay...I hadn't realized that it was a preventative treatment:
"This study examines the investigational drug brilacidin and its possible application in prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer."

May as well get it all out there:

Exclusion Criteria:

1. Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, larynx, hypopharynx or unknown primary tumor
2. Has metastatic disease (M1) Stage IV C
3. Has had prior radiation to the head and neck
4. Plan to be treated with cetuximab (Erbitux®)
5. Plan to be treated with induction chemotherapy before initiation of RT
6. Has a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excised
7. 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
8. Has incompletely healed sites of dental extractions
9. 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)
10. Has untreated hypertension (SBP =145 mmHg and/or DBP =90 mmHg)
11. Has active infectious disease undergoing systemic treatment excluding oral candidiasis
12. Has oral mucositis (of any severity) prior to initiation of radiation therapy
13. Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
14. Has known seropositivity for HIV or hepatitis C antibody, or antigen positive and antibody negative for hepatitis B (testing for these infections is not required for enrollment in this protocol)
15. Use of any investigational agent within 30 days of randomization
16. Is pregnant or breastfeeding
17. Has known allergies or intolerance to brilacidin, cisplatin or carboplatin
18. Has inability to give informed consent or comply with study requirements
19. 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.