A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.

Start Date27 Apr 2025

Sponsor / Collaborator

NRG Oncology

NCT06620029 / Not yet recruitingPhase 1/2

A Phase 1/2, Open-label Clinical Trial to Evaluate Safety and Efficacy of Combination Paclitaxel and BMX-001, in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer

This research project addresses the urgent need for novel therapeutic strategies to overcome chemotherapy resistance and mitigate chemotherapy-induced peripheral neuropathy (CIPN) in patients with recurrent ovarian and endometrial cancers, which are among the most lethal gynecologic malignancies worldwide. The study focuses on BMX-001, a redox-active manganese metalloporphyrin compound that uniquely combines the ability to enhance anti-tumor efficacy and protect normal tissues from the toxic effects of chemotherapy, specifically paclitaxel (PTX). PTX, despite being a cornerstone of treatment, is associated with significant dose-limiting neurotoxicity, which severely impacts patients quality of life and limits the use of subsequent therapies. BMX-001 has demonstrated potential in preclinical models to not only augment the anti-tumor effects of PTX but also reduce PTX-induced neuropathy.
The research will be conducted through a single-site, Phase 1/2 clinical trial led by the Duke Cancer Institute. The trial aims to determine the recommended Phase 2 dose of BMX-001 when combined with weekly PTX and to evaluate the clinical activity of this combination therapy. Specifically, the trial will assess the safety, tolerability, and potential to double the dose of BMX-001, which is hypothesized to further enhance the efficacy of PTX without increasing toxicity. The study's specific aims include establishing the recommended dose for expansion, assessing objective response rates (ORR), and quantifying the reduction in PTX-induced neurotoxicity using validated questionnaires and monofilament testing. The project also incorporates the analysis of circulating tumor DNA (ctDNA) as a biomarker for treatment response, adding a layer of precision to the evaluation of the therapy response impact on tumor burden.
The outcomes of this research have the potential to significantly improve treatment protocols for patients with chemo-resistant gynecologic cancers by offering a therapy that enhances tumor control while protecting against debilitating side effects. Successful completion of this trial will lay the groundwork for larger, definitive trials and may extend the benefits of BMX-001 to other solid tumors, ultimately contributing to better survival outcomes and quality of life for a broader patient population.

Start Date01 Apr 2025

Sponsor / Collaborator

BioMimetix JV LLC

NCT05254327 / RecruitingPhase 2IIT

A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma

In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.

Start Date15 Aug 2022

Sponsor / Collaborator

University of Nebraska

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100 Clinical Results associated with Manganese butoxyethyl pyridyl porphyrin

100 Translational Medicine associated with Manganese butoxyethyl pyridyl porphyrin

100 Patents (Medical) associated with Manganese butoxyethyl pyridyl porphyrin

Literatures (Medical) associated with Manganese butoxyethyl pyridyl porphyrin

09 May 2022·Oxidative medicine and cellular longevity

A Redox-active Mn Porphyrin, MnTnBuOE-2-PyP5+, Synergizes with Carboplatin in Treatment of Chemoresistant Ovarian Cell Line

Article

Author: St. Clair, William ; Yarana, Chontida ; Batinic-Haberle, Ines ; Chaiswing, Luksana ; Spasojevic, Ivan ; Tovmasyan, Artak ; St. Clair, Daret

We have employed a redox-active MnP (MnTnBuOE-2-PyP5+, Mn(III) meso-tetrakis (N-n-butoxyethylpyridinium-2-yl) porphyrin) frequently identified as superoxide dismutase mimic or BMX-001, to explore the redox status of normal ovarian cell in relation to two ovarian cancer cell lines: OV90 human serous ovarian cancer cell and chemotherapy-resistant OV90 cell (OVCD). We identified that OVCD cells are under oxidative stress due to high hydrogen peroxide (H2O2) levels and low glutathione peroxidase and thioredoxin 1. Furthermore, OVCD cells have increased glycolysis activity and mitochondrial respiration when compared to immortalized ovarian cells (hTER7) and parental cancer cells (OV90). Our goal was to study how ovarian cell growth depends upon the redox state of the cell; hence, we used MnP (BMX-001), a redox-active MnSOD mimetic, as a molecular tool to alter ovarian cancer redox state. Interestingly, OVCD cells preferentially uptake MnP relative to OV90 cells which led to increased inhibition of cell growth, glycolytic activity, OXPHOS, and ATP, in OVCD cells. These effects were further increased when MnP was combined with carboplatin. The effects were discussed with regard to the elevation in H2O2 levels, increased oxidative stress, and reduced Nrf2 levels and its downstream targets when cells were exposed to either MnP or MnP/carboplatin. It is significant to emphasize that MnP protects normal ovarian cell line, hTER7, against carboplatin toxicity. Our data demonstrate that the addition of MnP-based redox-active drugs may be used (via increasing excessively the oxidative stress of serous ovarian cancer cells) to improve cancer patients’ chemotherapy outcomes, which develop resistance to platinum-based drugs.

01 Nov 2021·INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS

The Phase I Results of a Phase 1/2 Trial for Patients With Newly Diagnosed Anal Cancer Treated With Concurrent Radiation Therapy, 5-Fluorouracil, Mitomycin and BMX-001

Article

Author: Doherty, E ; Penchev, S ; Crapo, J ; Kosmacek, E A ; Grem, J ; Chatterjee, A ; Filler-Katz, A ; Lin, C ; Klute, K ; Oberley-Deegan, R E

PURPOSE/OBJECTIVE(S):

Radiation therapy with concurrent 5-fluorouracil and mitomycin (MMC) (CRT) for patients with locally advanced anal squamous cell carcinoma (ASCC) results in long-term disease-free survival and sphincter preservation, but often with significant toxicity. RTOG trials showed 43-87% ≥ grade (G) 3 acute toxicity. We hypothesize that BMX-001, a scavenger of O2, will decrease CRT-associated toxicity without compromising the survival outcome. The objectives of this phase I trial were to determine the maximum tolerated (MTD) BMX-001 primarily, and secondarily evaluate outcomes.

MATERIALS/METHODS:

Eleven eligible stage II-III and pathologic confirmed ASCC patients received standard CRT. BMX-001 was given by sub-cutaneous injection, twice a week during CRT. Loading/maintenance dose escalation was as follows: 1) 7 and 3.5 mg/subject x 3; 2) 14 and 7 mg/subject x 3; 3) 28 and 14 mg/subject x 5. Endpoints (Toxicity and quality of life (QOL)) were assessed with CTCAE and EORTC QLQ-C30 questionnaires, respectively.

RESULTS:

All patients are free of disease with a median follow up of 17 (range 3-38) months. BMX-associated toxicity as follows: 6/11 G1 injection site erythema, 3/11 G2 sinus tachycardia, 1/11 G3 anxiety and hypertension and 1/11 G1 hypotension. All symptoms were relieved after hydrocortisone. No ≥ G 4 CRT-associated toxicities. G 1, 2 &3 CRT-associated toxicity during CRT was seen at skin (27/64/9%), gastrointestinal system (GI) (45/54/0%) and genitourinary system (GU) (64%/9/0%). All patients experienced anal pain during CRT (score 3-4/10: 44% and 5-9/10: 56%). At 1-month post-CRT, no G2 toxicity; G1 skin, GI and GU toxicity decreased to 0, 64 and 27%; Score 5-8/10 anal pain decreased to 27%. By 6 months, only 1 patient had anal pain scored 4/10 and 4 patients had G1 GI toxicity. Patients' physical, role and social functioning scores decreased to the lowest point at week 6 of CRT and returned to pre-CRT level at 1-month post-CRT. Emotional and cognitive functioning did not decrease significantly during CRT.

CONCLUSION:

BMX-001 MTD was not reached. A loading dose of 28 mg and a maintenance dose of 14 mg concurrent with CRT for anal squamous cell carcinoma is feasible and safe and is recommended for phase II trial. Concurrent CRT/BMX-001 was associated with decreased acute toxicities compared to RTOG data. Patients' decreased QOL during CRT returns to pre-CRT status in 1 month. Clinical trial number NCT03386500.

01 Nov 2021·INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS

A Phase 1-2 Trial of Concurrent Radiation Therapy, Cisplatin and BMX-001 in Locally Advanced Head and Neck Cancer

Article

Author: Mowery, Y M ; Brizel, D M ; Yom, S S ; Zhen, W ; Macleod, D ; Chan, J

PURPOSE/OBJECTIVE(S):

Prevention/mitigation of oral mucositis (OM) and xerostomia are challenges to the use of chemoradiation (CRT) for advanced head and neck squamous ca (HNSCC). MnTnBuOE-2-PyP5⁺(BMX-001) is a lipophilic manganese metalloporphyrin superoxide dismutase mimic that protects against radiation and chemotherapy induced OM in orthotopic animal tumor models. This study objective was to determine the toxicity profile of BMX-001 given during CRT for locally advanced HNSCC and to measure the incidence of severe (CTCAE v 4.03 grade 3-4) OM and xerostomia.

MATERIALS/METHODS:

Multi-center prospective phase 1-2 open label trial for patients with AJCC 7 stage III/IVB HNSCC undergoing concurrent RT/cisplatin, curative (70 Gy) or post-op (60-66 Gy). BMX-001 was administered subcutaneously 2x/week during CRT with an initial loading dose given up to 4 days prior to the start of CRT. Two additional doses of BMX-001 were given in the first week post-CRT. A 3+3 design was used. BMX-001 dose levels were 1: 7 mg load/3.5 mg maintenance; 2: 14 mg load/ 7mg maintenance; 3: 28 mg load/ 14 mg maintenance. Level 3 was expanded to assess phase 2 endpoints. Co-primary endpoints: toxicity of BMX-001 and the incidence of severe (grade 3-4) OM. OM was evaluated 2x/week during CRT and then weekly for 4 additional weeks. Secondary endpoints: median duration and time to onset of grade 3-4 OM, grade ≥2 xerostomia 1- and 6-months post-CRT, and progression-free survival (PFS).

RESULTS:

A total of 29 patients (M:F = 25:4) were enrolled from 5/2017-12/2019. Primary sites: p16+ oropharynx 25 (86%), nasopharynx (1), hard palate (1), unknown primary (2). Median age: 62 yo (IQR:56-67). Dose levels were 1 (3); 2 (3); dose 3 (23). Median RT dose: 70 Gy (IQR 70-70). 79.3% of subjects received > 200mg/m² of CDDP. All subjects on levels 1 and 2 received all BMX-001 as prescribed by protocol. Level 3, 19/23 (83%) received all doses of BMX-001. All patients had a grade 1 injection site reaction. There were 2 (7%) mild AEs related to QT interval prolongation and 3 serious adverse events (SAE) categorized as possibly related to BMX-001: hypotension, fever with pancytopenia, and hyponatremia. Other SAEs (n = 19) were judged to be expected due to the nature of the disease or treatment with CRT. Incidence of severe OM was 41% (median duration 25 days, IQR 25-47). Median time to onset of severe OM was 43 (IQR 34-52) days; 83.3% cases of severe OM resolved by 5 weeks post-CRT. Incidence of grade ≥ 2 xerostomia was 18%, 8%, and 9% at 1, 6, and 12 months respectively post-CRT. Mean unstimulated whole saliva production was 0.69 ml/min at baseline and 0.29 ml/min at 1 yr. Mean stimulated whole saliva production was 1.38 ml/min at baseline and 0.72ml/min at 1 yr. Median follow up was 20 mo. 1 yr PFS was 96.6%.

CONCLUSION:

CRT and 2x/week BMX-001 was safe in HNSCC at the highest dose tested. Promising rates of severe OM and xerostomia justify further investigation in HNSCC patients receiving CRT.

News (Medical) associated with Manganese butoxyethyl pyridyl porphyrin

17 Nov 2023

·www.biospace.com

BioMimetix Presents Data from Phase 2 Study of BMX-001 Demonstrating Increased Survival of 6.6 Months in High Grade Glioma Patients at the 2023 Society for Neuro-Oncology Annual Meeting

BMX-001 has the potential to augment tumor killing by radiation therapy and inhibits tumor regrowth by inhibiting pro-survival and pro-angiogenic transcription factors and HIF-1a In Phase 2 study, BMX-001 demonstrates increased overall survival and tolerable safety pro > GREENWOOD VILLAGE, Colo.--(BUSINESS WIRE)-- BioMimetix JV, LLC, a clinical-stage biotechnology company developing metalloporphyrins, a novel drug class for the treatment of cancer patients, today announced the presentation of encouraging data from its Phase 2 study of lead candidate, BMX-001, for the treatment of high-grade glioma (HGG) at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting. In the Phase 2 study, BMX-001 in combination with radiotherapy (RT) and temozolomide (TMZ) demonstrated a 6.6 month increase in median survival, mitigation of radiation-induced cognitive issues, and improved white matter integrity with a tolerable safety profile, compared to current standard of care. The abstract will be published in SNO’s official journal, Neuro-Oncology. “Patients with high grade glioma are challenging to treat because the disease grows quickly, ultimately outcomes are very poor for these patients and often carries an unfavorable prognosis. Current treatments aim to remove the tumor through surgery or slow its growth using chemotherapy and radiation therapy, but they are not curative and are associated with significant toxicities, including radiation-induced cognitive dysfunction that is responsible for negatively impacting the quality of life for our patients. The diversity of cases makes finding a cure difficult, and seeing durable responses in these patients is encouraging,” said Katy Peters, MD PhD FAAN (Lead Principal Investigator). “BMX-001 is a promising first-in-class molecule with clinically meaningful activity and the potential to become a new treatment option for patients diagnosed with high grade glioma.” “The exciting data presented today at SNO underscore what I have sought to achieve over the past several decades in our scientific research. The primary mechanism of action of a redox active metalloporphyrin is modulation of key pathways of cellular signaling in a pattern that augments radiation therapy in killing tumor cells while protecting normal tissues. This is demonstrated by the promising effects seen in this trial with BMX-001 on patients with high grade glioma receiving concurrent radiation and chemotherapies,” said James Crapo, M.D., Chief Executive Officer at BioMimetix. “High grade glioma is an aggressive brain cancer with a low survival rate that affects 10,000-15,000 people in the US per year. A substantial increase in median survival over the standard of care coupled with improved quality of life represents a significant stride towards bringing patients a transformative treatment. We are motivated to continue developing BMX-001 for this area of high unmet need, while also continuing to explore the utility of BMX-001 in other cancer types.” Presentation Highlights: The Phase 2 clinical trial included 160 subjects with newly diagnosed high grade glioma of which 145 completed protocol treatment. Patients on concurrent RT/TMZ who also received BMX-001 were found to have an increased median survival of 6.6 months. BMX-001 also mitigated radiation-induced cognitive issues - demonstrated by an increase in Hopkins Verbal Learning Test scores at 6-months post-baseline versus the control group, and an improvement in Brief Assessment of Cognition (BAC) scores. BMX-001 was found to have an excellent safety profile. Presentation Details: Title: Results of BMX-HGG study: a multi-institutional, randomized phase 2 clinical trial of concurrent chemoradiation with or without BMX-001 in patients with newly diagnosed high-grade glioma Abstract Number: LTBK-09 Date and Time: Friday, November 17, 2023, from 9:05 – 9:15 a.m. PT Session: Plenary I, Exhibit Hall C Presenter: Katherine Peters, M.D., Duke University Medical Center About BMX-001 BMX-001 is a metalloporphyrin, a novel class of redox-active, small molecule. The active center is designed to mimic the center of superoxide dismutase. The primary mechanism of action is modulation of cellular signaling pathways. BMX-001 inhibits both NFkB and HIF-1a. By inhibiting these pro-survival and pro-angiogenic transcription factors, BMX-001 augments tumor killing by radiation therapy and inhibits tumor regrowth. The inhibition of NFkB blocks major components of the inflammatory cascade which simultaneously results in protection of normal tissue from radiation induced injury. BMX-001 is also being developed in head and neck cancer, anal cancer, and rectal cancer and has been previously granted Orphan, Fast Track and Breakthrough designations by the FDA. About BioMimetix JV, LLC BioMimetix JV, LLC is a clinical-stage biotechnology company developing a novel platform drug class, metalloporphyrins, that enhances the effectiveness and safety of chemoradiation for the treatment of cancer patients. The Company’s robust clinical pipeline spanning multiple oncology indications is supported by demonstrated clinical efficacy in multiple ongoing clinical studies and extensive preclinical data.

Fast TrackClinical ResultPhase 2Radiation TherapyASCO

26 Oct 2023

·www.biospace.com

BioMimetix Announces Acceptance of Late-Breaking Abstract and Oral Presentation of BMX-001 Clinical Data at the 2023 Society for Neuro-Oncology Annual Meeting

GREENWOOD VILLAGE, Colo.--(BUSINESS WIRE)-- BioMimetix JV, LLC, a clinical-stage biotechnology company developing metalloporphyrins, a novel drug class for the treatment of cancer patients, today announced that data from its Phase 2 study of lead candidate, BMX-001, for the treatment of high-grade glioma (HGG), has been selected as a late breaking oral presentation at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting taking place on November 15-19, 2023 in Vancouver, Canada. In line with conference publication guidelines, Late-Breaking Abstracts will be made public at 7:00 a.m. PT on the first day of the meeting, Friday, November 17, 2023 and at . Details of the oral presentation are as follows: Title: Results of BMX-HGG study: a multi-institutional, randomized phase 2 clinical trial of concurrent chemoradiation with or without BMX-001 in patients with newly diagnosed high-grade glioma Abstract Number: LTBK-09 Date and Time: Friday, November 17, 2023, from 9:05 – 9:15 a.m. PT Session: Plenary I, Exhibit Hall C Presenter: Katherine Peters, M.D., Duke University Medical Center About BioMimetix JV, LLC BioMimetix JV, LLC is a clinical-stage biotechnology company developing a novel platform drug class, metalloporphyrins, that enhances the effectiveness and safety of chemoradiation for the treatment of cancer patients. The Company’s robust clinical pipeline spanning oncology and dermatology indications are supported by demonstrated clinical efficiency in ongoing clinical studies and extensive preclinical data in solid tumors as well as inflammatory skin diseases. BioMimetix’s lead candidate, BMX-001, is currently being evaluated for a Phase 3 pivotal trial in high-grade glioma.

Phase 2ASCOPhase 3

01 May 2023

·www.prnewswire.com

Significant Positive Shift in the Glioma Market with 13% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the glioma market are anticipated to change in the coming years owing to the positive outcomes of the emerging pipeline candidates during the developmental stage by key players, such as Bayer, VBL Therapeutics, Candel Therapeutics, AstraZeneca, DNAtrix, DelMar Pharmaceuticals, Chimerix, KaryoPharma, VBI Vaccines, Kazia Therapeutics, and others LAS VEGAS, May 1, 2023 /PRNewswire/ -- DelveInsight's Glioma Market Insights report includes a comprehensive understanding of current treatment practices, glioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Glioma Market Report As per DelveInsight analysis, the glioma market size in the 7MM was approximately USD 1 billion in 2022. According to the assessment done by DelveInsight, the estimated total incident glioma cases in the 7MM were approximately 47K in 2022. Leading glioma companies such as Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai and Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, VBI Vaccines, TME Pharma, Day One Biopharmaceuticals, Servier, Orbus Therapeutics, TVAX Biomedical, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Forma Therapeutics, Hoffmann-La Roche, Incyte Corporation, Eli Lilly, and others are developing novel glioma drugs that can be available in the glioma market in the coming years. The promising glioma therapies in the pipeline include Regorafenib, ONC201, AV-GBM-1, Enzastaurin (DB-102), DCVax-L, Ofranergene Obadenovec (VB-111), LAM561 (2-OHOA), MEDI4736 (durvalumab), Tasadenoturev (DNX-2401), ITI-1000 (pp65 DC Vaccine), IGV-001, SurVaxM, Berubicin, GLIOVAC (Sitoiganap), Lerapolturev + Pembrolizumab, SONALA-001 + Exablate 2.0 Device, VAL-083 (dianhydrogalactitol), Pomalidomide, MDNA55, BMX-001, Lenvatinib ± Pembrolizumab, Paxalisib (GDC-0084), OKN-007, Temferon, EO2401, INO-5401+ INO-9012+ LIBTAYO (cemiplimab), Selinexor (KPT-330), Olutasidenib (FT-2102), VBI-1901, NOX-A12 (Olaptesed Pegol), Tovorafenib (DAY101), Vorasidenib (AG-881), Eflornithine, TVI-Brain-1, AB-218, BGB-290, Mirdametinib, FT-2102 (Olutasidenib), Vinblastine + Bevacizumab, Cobimetinib, PEMAZYRE (Pemigatinib), VERZENIO (abemaciclib) , and others. In December 2022, Chimerix announced the successful launch of the ONC201 Phase III ACTION study in patients with H3 K27M-mutant glioma. In June 2022, Day One Biopharmaceuticals announced positive initial data from its pivotal Phase II (FIREFLY-1) study with tovorafenib (DAY101) in relapsed pediatric low-grade glioma (pLGG). Discover which therapies are expected to grab the major glioma market share @ Glioma Market Report Glioma Overview Glioma is the most common kind of glial cell tumor in the central nervous system (CNS). Gliomas are infiltrative tumors that affect the brain tissue surrounding them. Glioblastoma is the most hazardous type of brain tumor, whereas pilocytic astrocytomas are the least dangerous. Previously, diffuse gliomas were classified into subgroups and grades depending on histopathologies, such as diffuse astrocytomas, oligodendrogliomas, or mixed gliomas/oligoastrocytomas. The specific etiology of glioma, like other primary brain tumors, remains unknown. However, certain variables may increase the risk of getting a brain tumor. Glioma symptoms vary depending on tumor type, size, location, and growth rate. Some common glioma symptoms include headache, nausea or vomiting, memory loss, urine incontinence, speech problems, and others. A medical history and a physical examination are used for glioma diagnosis. Glioma Epidemiology Segmentation DelveInsight estimates that there were approximately 47K incident cases of glioma in the 7MM in 2022. As per our analysis, the United States contributed to the largest incident population of glioma, acquiring ~40% of the 7MM in 2022. The glioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total glioma incident cases Glioma grade-specific cases Glioma age-specific cases Glioma type-specific cases Download the report to understand which factors are driving glioma epidemiology trends @ Glioma Epidemiological Insights Glioma Treatment Market Glioma treatment is based on the type of glioma, its size and location, and the patient's unique characteristics. Chemotherapy and radiation therapy will be administered after surgery, particularly in individuals when the tumor cannot be removed entirely because it has invaded critical parts of the brain or is inaccessible. The typical glioma treatment protocol comprises surgery, chemotherapy, and radiation. Chemotherapy may include carmustine (BCNU), lomustine (CCNU), or gleostine (generic), cisplatin, carboplatin, etoposide, and irinotecan in case of low-grade glioma whereas temozolomide (TEMODAR) is the standard chemotherapy used in case of high-grade glioma majorly, Gliadel wafer implants (biodegradable discs injected with BCNU) are usually given as adjunctive treatment after surgery, although usage of Gliadel wafers remains a point of controversy due to its questionable survival benefits. Avastin (Genentech) and Temodar/Temodal (Merck), among others, are approved medications for HGG. However, due to patent expiration, the generic version of Temodar and biosimilars of Avastin are available on the glioma market. As generics and biosimilars are more cost-effective for patients than new medicines, intense competition exists among them. Furthermore, due to a lack of knowledge concerning bevacizumab's overall survival benefit, it is not recommended in unselected patients with newly diagnosed GBM. Currently, only one medication for LGG is approved, Tafinlar (dabrafenib) plus Mekinist (trametinib). Moreover, the current therapeutic market lacks a viable method for curing glioblastoma; therefore, the survival rate of people diagnosed with glioma remains poor. Glioma is incurable, and treatment choices are limited. Furthermore, the tumor has a high recurrence rate and a poor patient prognosis. In addition, there is currently no approved therapy for the unmethylated MGMT patient pool. To know more about glioma treatment guidelines, visit @ Glioma Management Glioma Therapies and Key Companies Regorafenib: Bayer ONC201: Chimerix AV-GBM-1: Aivita Biomedical Enzastaurin (DB-102): Denovo Biopharma DCVax-L: Northwest Therapeutics Ofranergene Obadenovec (VB-111): VBL Therapeutics LAM561 (2-OHOA): Laminar Pharmaceuticals MEDI4736 (durvalumab): MedImmune Tasadenoturev (DNX-2401): DNAtrix ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics IGV-001: Imvax SurVaxM: MimiVax Berubicin: CNS Pharmaceuticals GLIOVAC (Sitoiganap): Epitopoietic Research Corporation (ERC) Lerapolturev + Pembrolizumab: Istari Oncology SONALA-001 + Exablate 2.0 Device: SonALAsense VAL-083 (dianhydrogalactitol): Kintara Therapeutics Pomalidomide: Bristol Myers Squibb MDNA55: Medicenna Therapeutics BMX-001: BioMimetix Lenvatinib ± Pembrolizumab: Eisai and Merck Sharp & Dohme Paxalisib (GDC-0084): Kazia Therapeutics OKN-007: Oblato Temferon: Genenta Science EO2401: Enterome INO-5401+ INO-9012+ LIBTAYO (cemiplimab): Inovio Pharmaceuticals Selinexor (KPT-330): Karyopharm Therapeutics VBI-1901: VBI Vaccines NOX-A12 (Olaptesed Pegol): TME Pharma Tovorafenib (DAY101): Day One Biopharmaceuticals Vorasidenib (AG-881): Servier Eflornithine: Orbus Therapeutics TVI-Brain-1: TVAX Biomedical AB-218: AnHeart Therapeutics BGB-290: Beigene Mirdametinib: SpringWorks Therapeutics FT-2102 (Olutasidenib): Forma Therapeutics Vinblastine + Bevacizumab: Hoffmann-La Roche Cobimetinib: Hoffmann-La Roche PEMAZYRE (Pemigatinib): Incyte Corporation VERZENIO (abemaciclib): Eli Lilly Learn more about the FDA-approved drugs for glioma @ Drugs for Glioma Treatment Glioma Market Dynamics Glioma market growth can be ascribed to various factors, including an aging population, evolving research, better diagnostic tests, developing surgical procedures, improved radiotherapy techniques, and novel systemic medicines. Commercially, there is a greater emphasis on high-grade glioma than low-grade glioma because patients with low-grade glioma often live longer than those with high-grade glioma. As a result, just a few therapies are in late-stage studies, while the majority are in early-stage trials. In the case of GBM, on the other hand, the pipeline is robust, with numerous potential therapies in late and mid-stage research that have yet to be marketed. The pipeline includes drugs with varied modes of action and administration routes. It is interesting to note that the emerging market of glioma includes budding gene therapy, i.e., ofranergene obadenovec (VB-111) by VBL Therapeutics, followed by four vaccine/immunotherapy candidates such as VBI-1901, AV-GBM-1 and ITI-1000 (pp65 DC Vaccine), tasadenoturev (DNX-2401) by VBI Vaccines, Aivita Biomedical, Immunomic Therapeutics, and DNAtrix, respectively, and these therapies are going to alter the glioma market dynamics in the upcoming years. The current glioma market has been categorized based on the dominant treatment pattern across the 7MM, which shows slight variances in the overall prescription pattern. The forecast model considers surgery, chemotherapy/radiation therapy, bevacizumab + radiotherapy/chemotherapy, and OPTUNE with temozolomide. The anticipated launch of new therapies and improved integration of early patient screening, medication in secondary care and other clinical settings, research on optimum implementation methods, and increased awareness may eventually facilitate the development of successful treatment alternatives. However, there are a few challenges to the timely identification and treatment of these patients, such as a lack of a reliable biomarker that can aid in diagnosis and patient classification and identifying recurrence and signaling medication response. Furthermore, the failure rate of high-phased drug trials is significant, making it impossible to predict trial success, exacerbating the need for medicines that could assist ease the patient segment with this severe kind of cancer. Scope of the Glioma Market Report Therapeutic Assessment: Glioma current marketed and emerging therapies Glioma Market Dynamics: Conjoint Analysis of Emerging Glioma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Glioma Market Access and Reimbursement Discover more about glioma drugs in development @ Glioma Clinical Trials Table to Contents Related Reports Glioma Epidemiology Forecast Glioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted glioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Glioma Pipeline Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioma companies, including PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, among others. High-Grade Glioma Pipeline High-Grade Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key high-grade glioma companies, including PTC Therapeutics, Aadi, Lee's Pharmaceutical, among others. Malignant Glioma Pipeline Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant glioma companies, including Bexion Pharmaceuticals, Inc., Lee's Pharmaceutical Limited, Merck & Co, Oblato, Inc., OncoSynergy, Inc, among others. Recurrent Malignant Glioma Pipeline Recurrent Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent malignant glioma companies, including Bexion Pharmaceuticals, Inc., Merck, Oblato, OncoSynergy, Inc, among others. Glioblastoma Pipeline Glioblastoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioblastoma companies, including AstraZeneca, BioNTech, Merck, Pfizer, Roche, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2VaccineImmunotherapy

100 Deals associated with Manganese butoxyethyl pyridyl porphyrin

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
High grade glioma	Phase 3	-	BioMimetix JV LLC	-
Platinum-Resistant Ovarian Carcinoma	Phase 2	US	BioMimetix JV LLC	01 Apr 2025
Recurrent Endometrial Cancer	Phase 2	US	BioMimetix JV LLC	01 Apr 2025
Rectal Adenocarcinoma	Phase 2	US	BioMimetix JV LLC	15 Aug 2022
Brain metastases	Phase 2	US	BioMimetix JV LLC	10 Aug 2022
Head and Neck Neoplasms	Phase 2	-	BioMimetix JV LLC	01 Jul 2021
Head and Neck Neoplasms	Phase 2	-	Duke University	01 Jul 2021
Glioblastoma	Phase 2	US	BioMimetix JV LLC	25 Sep 2018
squamous cell carcinoma of the anus	Phase 2	US	BioMimetix JV LLC	28 Nov 2017
Locally Advanced Malignant Neoplasm	Phase 2	US	BioMimetix JV LLC	19 Apr 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02655601 (SNO2023) Manual	Phase 2	High grade glioma First line	160	BMX-001+RT+Temozolomide	nhdagofuzw(xwggekwmso) = pweenwtgxm brschgjfvt (pgumfhirpd, 21.6 - NR)	Positive	17 Nov 2023
				RT+Temozolomide	nhdagofuzw(xwggekwmso) = vakxzjvlcg brschgjfvt (pgumfhirpd, 19.6 - 32.6)
NCT02990468 (BMX-HN, CTgov)	Phase 1/2	Locally Advanced Malignant Neoplasm \| Head and Neck Neoplasms	29	cisplatin (Phase 1: Group 1)	aoqamkyrox(qaqmkbqiap) = qbijbxruyw pzbwolushh (zysgwiohof, abiqdbidht - ybmxiqieyy) View more	-	15 Mar 2023
				cisplatin (Phase 1: Group II)	aoqamkyrox(qaqmkbqiap) = bmlamehhps pzbwolushh (zysgwiohof, cwuttocyom - hgrfvidutx) View more
ASTRO2019	Not Applicable	High grade glioma	-	BMX-001 28 mg loading dose and 14 mg subsequent dose	lezguvaucc(grljbtjipv) = grade 3, n=1 plcunahtjw (rvxjtrsxtn ) View more	-	01 Sep 2019

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