BMX-001 + Chemoradiation for Brain Cancer

(BMX-HGG Trial)

No longer recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioMimetix JV, LLC

Must be taking: Temozolomide

Must not be taking: Immuno-suppressive agents

Disqualifiers: Pregnancy, Infection, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BMX-001, for individuals with high-grade glioma, an aggressive brain cancer. The researchers aim to determine if adding BMX-001 to the standard treatment of radiation therapy and temozolomide can improve survival and protect brain function. Participants will receive either the standard treatment with BMX-001 or without it to compare outcomes. Those recently diagnosed with high-grade glioma and about to start standard radiation and chemotherapy might be suitable candidates. As a Phase 1, Phase 2 trial, this research focuses on understanding how BMX-001 works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot take medications that interfere with the study results, like certain immune-suppressing drugs or those affecting liver enzymes. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BMX-001, when combined with standard radiation therapy and the chemotherapy drug temozolomide, appears safe. Studies have found that BMX-001 can protect healthy tissues from radiation damage, indicating its safety. This treatment also helps slow tumor growth.

In earlier studies with patients who have high-grade glioma, BMX-001 was generally well-tolerated, with no major safety issues reported. This suggests it is safe at the doses being tested. It is important to note that this treatment is still under study, but early results are promising regarding its safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about BMX-001 because it introduces a new approach to enhancing the effectiveness of standard brain cancer treatments like radiation therapy and temozolomide. Unlike current options, BMX-001 is an antioxidant that is administered via subcutaneous injection and may protect healthy cells from damage during radiation, potentially reducing side effects. This unique mechanism of action could improve patient outcomes by allowing higher doses of radiation to be used more safely, or by enhancing the effectiveness of the existing standard treatments.

What evidence suggests that this trial's treatments could be effective for high grade glioma?

In this trial, participants in one arm will receive BMX-001 combined with radiation therapy and the drug temozolomide. Research has shown that BMX-001, when used with radiation therapy and temozolomide, can extend the lives of patients with high-grade glioma by about 6.6 months. This is significant, as these patients typically live between 12 to 16 months. BMX-001 may also protect against memory and thinking problems often caused by radiation treatment. Studies have found that brain functions can remain stable or even improve with this treatment combination. Overall, BMX-001 appears promising for not only extending life but also maintaining quality of life for individuals with this type of brain cancer. ^{3 4 5 6 7}

Who Is on the Research Team?

Katherine Peters, MD, PhD

Principal Investigator

Duke Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a recent (within 12 weeks) surgical intervention for high-grade glioma, WHO grade III or IV. They must be ready to start standard radiation and chemotherapy, have good organ function and performance status, agree to use contraception if sexually active, and not have any severe infections or other health conditions that could interfere with the study.

Inclusion Criteria

If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 12 months afterwards as stated in the informed consent

Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/µl, platelets ≥ 125,000 cells/µl

Serum creatinine ≤ 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal

Exclusion Criteria

Severe allergy to contrast agent

Pregnancy or breast-feeding

Metal in the body (except dental fillings) e.g., pacemaker, infusion pump, metal aneurysm clip, metal prosthesis, joint, rod or plate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive radiation therapy and temozolomide, with BMX-001 administered subcutaneously for 8 weeks

8 weeks

Weekly visits for CBC and CMP

Adjuvant Chemotherapy

Participants transition to adjuvant chemotherapy with temozolomide for 12 cycles

12 months

Every 8 weeks for MRI and cognitive testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 8 weeks for MRI and cognitive testing

What Are the Treatments Tested in This Trial?

Interventions

• BMX-001
• Radiation Therapy
• Temozolomide

Trial Overview The trial is testing BMX-001 in combination with standard radiation therapy and temozolomide in patients newly diagnosed with high-grade glioma. The goal is to see if BMX-001 improves survival rates and cognitive functions compared to the standard treatment alone. Patients are randomly assigned to either receive BMX-001 along with chemoradiation or just chemoradiation.

How Is the Trial Designed?

Group I: Phase 2 Arm A: Radiation Therapy, TMZ and BMX-001 Experimental Treatment 3 Interventions

Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects will receive BMX-001 in this phase.

Group II: Phase 1 Experimental Treatment 3 Interventions

All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\])

Group III: Phase 2 Arm B: Radiation Therapy and TMZ Active Control 2 Interventions

In this arm, one-half of the study subjects will not receive BMX-001 but will undergo all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects will be in this study arm.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

BioMimetix JV, LLC

Lead Sponsor

Trials

11

Recruited

700+

Duke Cancer Institute

Collaborator

Trials

17

Recruited

3,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10655627/

LTBK-09. RESULTS OF BMX-HGG STUDY Overall survival (OS) for GBM is roughly 12-16 months. RT is associated with cognitive and quality of life (QoL) impairments. Advances are needed to improve OS ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.TPS2577

BMX-HGG: Phase II trial of newly diagnosed high-grade ... We evaluated the safety of BMX-001 in combination with concurrent RT and temozolomide (TMZ) in a phase I study of newly diagnosed high-grade glioma patients.

3. trials.braintumor.org trials.braintumor.org/trials/NCT02655601

Trial of Newly Diagnosed High Grade Glioma Treated With ... BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/biomimetix-reports-positive-data-from-phase-ii-glioma-trial/

BioMimetix reports positive data from Phase II glioma trial BioMimetix has announced that its BMX-001 combined with radiotherapy and temozolomide has increased median survival by 6.6 months in glioma patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9354202/

SPCR-03 NEUROCOGNITIVE OUTCOMES FROM PHASE ... Neurocognitive function is maintained and can improve after concurrent radiation therapy and temozolomide in this high-grade glioma cohort treated with BMX-001 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27098749/

Nonclinical Safety and Toxicokinetics of MnTnBuOE-2- ... BMX-001, a manganese porphyrin that has anti-inflammatory, antioxidant, and antitumor properties, is being developed as a potential therapeutic for high-grade ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03608020

A Trial for Treatment of Cancer Patients With Multiple Brain ... Preliminary studies have demonstrated that BMX-001 provides protection of normal tissues from radiation-induced injury and augments tumor growth inhibition.