Trial Outcomes & Findings for A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer (NCT NCT02990468)

Last Updated: 2023-03-15

Results Overview

This outcome is to confirm the safety and tolerability of escalating doses of BMX-001 in conjunction with RT and concurrent cisplatin in a cohort of newly diagnosed patients with locally advanced head and neck cancers. Each dose will be reported separately.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

29 participants

Primary outcome timeframe

1 year

Results posted on

2023-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1: Group 1 Participants were administered a 7 mg loading dose followed by a 3.5 mg maintenance dose twice a week for up to 8 weeks while receiving concurrent cisplatin and RT.	Phase 1: Group II Participants were administered a 14 mg loading dose followed by a 7 mg maintenance dose twice a week for up to 8 weeks while receiving concurrent cisplatin and RT.	Phase 2: Group III - MTD Participants were administered a 28 mg loading dose followed by a 14 mg maintenance dose twice a week for up to 8 weeks while receiving concurrent cisplatin and RT.
Phase 1: Dose Escalation STARTED	3	3	0
Phase 1: Dose Escalation COMPLETED	3	3	0
Phase 1: Dose Escalation NOT COMPLETED	0	0	0
Phase 2: MTD STARTED	0	0	23
Phase 2: MTD COMPLETED	0	0	22
Phase 2: MTD NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: Group 1 Participants were administered a 7 mg loading dose followed by a 3.5 mg maintenance dose twice a week for up to 8 weeks while receiving concurrent cisplatin and RT.	Phase 1: Group II Participants were administered a 14 mg loading dose followed by a 7 mg maintenance dose twice a week for up to 8 weeks while receiving concurrent cisplatin and RT.	Phase 2: Group III - MTD Participants were administered a 28 mg loading dose followed by a 14 mg maintenance dose twice a week for up to 8 weeks while receiving concurrent cisplatin and RT.
Phase 2: MTD Change in treatment	0	0	1

Baseline Characteristics

A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Group I n=3 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group II n=3 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=23 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants
Age, Continuous	57.33 years STANDARD_DEVIATION 12.97 • n=5 Participants	67.67 years STANDARD_DEVIATION 4.91 • n=7 Participants	60.96 years STANDARD_DEVIATION 7.66 • n=5 Participants	61.28 years STANDARD_DEVIATION 8.51 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	20 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	23 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	23 participants n=5 Participants	29 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Each dosing group reported seperately.

Outcome measures

Outcome measures
Measure	Phase 1: Group II n=3 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=23 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group 1 n=3 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Assess the Safety of the Study Drug by Calculating the Proportion of Patients Who Experience Grade 4 or 5 Study Drug Related Adverse Events, as Assessed by CTCAE v 4.03.	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 months

Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Higher scores are indicative of worse symptoms. Grade 0-5. We are reporting the incidence of the patients that had mucositis grade 1-5.

Outcome measures

Outcome measures
Measure	Phase 1: Group II n=3 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=23 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group 1 n=3 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Incidence Radiation-induced Mucositis by Clinician Scoring	1 Participants	10 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: one subject in group 3 did not complete follow up and was excluded from analysis

Xerostomia will also be assessed by measurement of stimulated saliva production posttreatment.

Outcome measures

Outcome measures
Measure	Phase 1: Group II n=3 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=22 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group 1 n=3 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Incidence of Radiation-induced Xerostomia by Stimulated Saliva Production	2.387 gram Standard Deviation 0.688	2.115 gram Standard Deviation 1.151	1.487 gram Standard Deviation 0.144

SECONDARY outcome

Timeframe: 6 months

Population: one subject in group 3 did not complete follow up and was excluded from analysis

Xerostomia will also be assessed by measurement of unstimulated saliva production post treatment.

Outcome measures

Outcome measures
Measure	Phase 1: Group II n=2 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=22 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group 1 n=2 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production	1.090 gram Standard Deviation 0.334	1.255 gram Standard Deviation 0.932	0.42 gram Standard Deviation 0.041

SECONDARY outcome

Timeframe: 6 months

Population: One subject in group 3 did not complete follow up and was excluded from the analysis (a score of 0 representing no xerostomia)

Xerostomia will be assessed using Maximum Xerostomia Clinical Score Common Terminology Criteria for Adverse Events (CTCAE) 4.03. Scores range from 0 to 5 with 0 being no xerostomia and 5 being the worst. Mean maximum xerostomia grade of patients assessed is reported.

Outcome measures

Outcome measures
Measure	Phase 1: Group II n=3 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=22 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group 1 n=3 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Incidence of Radiation-induced Xerostomia by Clinician Scoring	1.33 score on a scale Standard Error 0.27	1.29 score on a scale Standard Error 0.13	1 score on a scale Standard Error 0

SECONDARY outcome

Timeframe: 6 month 6 months

Population: only the patients that had mucositis were evaluated for duration

Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Duration of Oral Mucositis WHO Grade 3 or higher measured as the days of severe oral mucositis.

Outcome measures

Outcome measures
Measure	Phase 1: Group II n=1 Participants Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=10 Participants Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group 1 n=1 Participants Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Duration of Radiation-induced Mucositis	18 days Standard Error NA The sample size is too small to calculate standard error.	37.4 days Standard Error 8.2	22 days Standard Error NA The sample size is too small to calculate standard error.

SECONDARY outcome

Timeframe: 30 days

Population: Data was not collected or analyzed

To examine the impact on radiation dermatitis of BMX-001 in combination with RT and concurrent cisplatin at 30-39 Gy, 40-49 Gy, 50-59 Gy, and 60-70 Gy, the duration of radiation dermatitis, and evaluation of radiation dermatitis-related patient-reported outcomes

Outcome measures

Outcome data not reported

Adverse Events

Phase 1: Group I

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: Group II

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 2: Group III

Serious events: 11 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: Group I n=3 participants at risk Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 1: Group II n=3 participants at risk Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.	Phase 2: Group III n=23 participants at risk Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
Gastrointestinal disorders Abdominal Infection	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Investigations Blood creatinine increased	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Renal and urinary disorders Febrile neutropenia	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Gastrointestinal disorders Gastronomy failure	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Respiratory, thoracic and mediastinal disorders Lung infection	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Vascular disorders Presyncope	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
General disorders Pyrexia	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	13.0% 3/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Infections and infestations Sepsis	33.3% 1/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	4.3% 1/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.
Investigations Weight decreased	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	0.00% 0/3 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.	8.7% 2/23 • From the time the subject signs the informed consent form through and of treatment visit (one year follow up) An AE can therefore be any unfavorable and unintended or worsening sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of BMX-001, whether or not related to use of the BMX-001. Abnormal laboratory findings without clinical significance (based on the PI's judgment) should not be recorded as AEs, but laboratory value changes that require therapy or adjustment in prior therapy are considered adverse events.

Other adverse events

Additional Information

Director of Clinical Operations

BioMimetix JV LLC

Phone: 303-862-7268

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place