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.

开始日期2025-04-27

申办/合作机构

NRG Oncology

NCT06620029

/ Not yet recruiting临床1/2期

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.

开始日期2025-04-01

申办/合作机构

BioMimetix JV LLC

NCT05254327

/ Recruiting临床2期IIT

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.

开始日期2022-08-15

申办/合作机构

University of Nebraska

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项与卟啉锰相关的文献（医药）

2022-05-09·Oxidative medicine and cellular longevity

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

Article

作者: 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.

2021-11-01·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

作者: Doherty, E ; Crapo, J ; Penchev, S ; Kosmacek, E A ; Grem, J ; Filler-Katz, A ; Chatterjee, 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.

2021-11-01·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

作者: Brizel, D M ; Mowery, Y M ; Yom, S S ; Macleod, D ; Zhen, W ; 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.

项与卟啉锰相关的新闻（医药）

2025-05-29

·PRNewswire

Anal Cancer Market Heats Up Following Incyte's Zynyz Greenlight | DelveInsight

Several companies are advancing treatments for anal cancer, including Merck (KEYTRUDA), BioMimetix (BMX-001), Novartis (KFA115), and Bicara Therapeutics (BCA101), among others. As immunotherapy and targeted therapies gain traction, competition will increase, raising the bar for efficacy and safety. The market is shifting toward personalized, less toxic treatments, creating opportunities for novel entrants but demanding strong differentiation. LAS VEGAS, May 29, 2025 /PRNewswire/ -- Anal cancer is relatively uncommon, accounting for approximately 2.5% of all gastrointestinal cancers. Nonetheless, its incidence has been gradually increasing over the past 30 to 40 years. The disease is more frequently diagnosed in women than in men and typically affects individuals between the ages of 45 and 75. Anal squamous cell carcinoma (ASCC) is the predominant type, comprising around 80–85% of anal canal cancer cases. Less frequent forms include adenocarcinomas, melanomas, and basal cell carcinomas. According to DelveInsight's analysis, there were around 20,000 new cases of anal cancer across the seven major markets in 2023, a figure projected to rise by 2034. In the United States, approximately 82% of anal cancer cases were linked to HPV, underlining it as the primary cause. Combination chemoradiotherapy (CRT) is the standard first-line treatment for locoregional anal cancer. However, an exception is made for early-stage perianal tumors that do not involve the anal sphincter and for superficially invasive squamous cell carcinoma (SCC) of the anus, where wide local excision may be appropriate. The treatment approach for anal cancer has evolved from surgery to combined chemoradiation, enabling preservation of anal function. Despite trials investigating induction chemotherapy, maintenance therapy, and planned treatment breaks, the established standard remains a combination of mitomycin C (MMC), 5-fluorouracil (5-FU), and radiotherapy (RT) without these additional modifications. In recent years, intensity-modulated radiotherapy (IMRT) has replaced older radiotherapy methods and is now considered standard practice. Current research efforts also aim to reduce radiation-related side effects, with bone marrow-sparing IMRT emerging as a promising technique to limit hematologic toxicity. While immunotherapy is currently recommended as a second-line option for metastatic disease, its role is being actively explored in the locoregional setting. In particular, immune checkpoint inhibitors (ICIs) have garnered significant attention in recent studies involving patients with locoregional squamous cell carcinoma of the anus (SCCA). Learn more about the anal cancer treatment @ New Treatment for Anal Cancer Incyte's PD-1 inhibitor Zynyz has re-emerged in the treatment of anal cancer following two concurrent FDA approvals, marking a significant turnaround four years after its initial rejection. In May, 2025, the FDA approved Zynyz, a humanized monoclonal antibody targeting PD-1, for use alongside carboplatin and paclitaxel as a first-line therapy for adults with inoperable, locally recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, Zynyz received approval as a monotherapy for adults with locally recurrent or metastatic SCAC who have either progressed on or are unable to tolerate platinum-based chemotherapy. Previously approved in 2023 for treating metastatic, recurrent, or locally advanced Merkel cell carcinoma, Zynyz has now become a cornerstone of Incyte's oncology pipeline. Its latest approval follows a Priority Review of a supplemental Biologics License Application (sBLA), backed by data from two clinical trials: the Phase III POD1UM-303/InterAACT2 and the Phase II POD1UM-202 studies. The Phase III POD1UM-303/InterAACT2 trial evaluated Zynyz in combination with carboplatin and paclitaxel in patients with metastatic or inoperable, locally recurrent SCAC who had not previously received systemic chemotherapy. The Phase II POD1UM-202 trial focused on Zynyz as a standalone therapy for patients with advanced SCAC who had relapsed after or were intolerant to platinum-based regimens. The intravenous monotherapy approval was based on results from POD1UM-202, which demonstrated a 14% objective response rate (ORR) and a 49% disease control rate. The safety profile was consistent with expectations for PD-1 inhibitors and showed no negative impact on HIV management in infected patients. Serious adverse events occurred in 40% of patients, with the most common (≥2%) including infections (excluding urinary tract), abdominal and perineal pain, anemia, bleeding, diarrhea, fever, urinary tract infections, musculoskeletal pain, and respiratory symptoms. Find out more on FDA-approved anal cancer drugs @ Anal Cancer Treatment Options Alongside the US submission, Incyte has also filed a Type II variation Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) and a Japanese New Drug Application (J-NDA) with the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC. Both applications are currently under review. The approval of Zynyz has heightened competition among pharmaceutical players such as Merck, BioMimetix, Novartis, and Bicara Therapeutics, pushing them to fast-track the development of their flagship drug candidates to gain market share and challenge Incyte's foothold. Discover which therapies are expected to grab major anal cancer market share @ Anal Cancer Market Report Merck is advancing its blockbuster PD-1 inhibitor, KEYTRUDA, which is currently in Phase II trials. Upon approval, it is expected to directly rival Incyte's Zynyz in the anal cancer treatment space. Zynyz (retifanlimab) could soon face competition not only from other PD-1 inhibitors but also from innovative therapies beyond this class. A notable example is BioMimetix's BMX-001, a redox-active metalloporphyrin (MnP) small molecule known for its strong anti-inflammatory effects. BMX-001 acts through a dual mechanism that affects both tumor and healthy tissues. In cancer cells, it inhibits critical signaling pathways such as NF-κB and HIF-1α, which are key to inflammation, angiogenesis, and tumor survival. This inhibition supports cancer cell death, reduces blood vessel formation, and curtails long-term tumor growth. BioMimetix is currently enrolling patients in a Phase I/II clinical trial involving newly diagnosed anal cancer cases. Other emerging anal cancer treatments include Novartis' immunomodulator KFA115 and Bicara Therapeutics' bifunctional antibody BCA101, which targets both EGFR and TGFβ pathways. Discover more about drugs for anal cancer in development @ Anal Cancer Clinical Trials Overall, the anal cancer therapeutic pipeline appears robust, with a variety of innovative strategies in development that could transform treatment paradigms and enhance patient outcomes. The anticipated launch of these emerging therapies for anal cancer are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for anal cancer is expected to grow from USD 7 million in the 7MM in 2023 at a significant CAGR by 2034. The anal cancer market is witnessing steady growth, driven by rising incidence rates, increased awareness, and advancements in diagnostic and treatment options. HPV remains a major contributing factor, prompting the development of targeted therapies and preventive vaccines. Improved screening programs and the approval of novel immunotherapies are further fueling market expansion. Additionally, growing investments in oncology research are supporting innovation and long-term market potential. DelveInsight's latest published market report, titled as Anal Cancer Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the anal cancer country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The anal cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Incident Cases of Anal Cancer Gender-specific Cases Age-specific Cases Histology-specific Cases HPV Status-specific Cases Stage-specific Cases Line-wise Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM anal cancer market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this anal cancer market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the anal cancer market. Also, stay abreast of the mitigating factors to improve your market position in the anal cancer therapeutic space. Related Reports HPV16-Positive Head and Neck Squamous Cell Carcinoma HPV16-Positive Head and Neck Squamous Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report shows that the 7MM market size is predicted to rise from USD 750 million in 2023 at a significant CAGR by 2034 owing to the active participation of key companies, including Bristol Myers Squibb, Merck, Merus, Exelixis, ISA Pharmaceuticals, Regeneron Pharmaceuticals, PDS Biotechnology, BioNTech, Cue Biopharma, Immutep, Iovance Biotherapeutics, Inovio Pharmaceuticals, MedImmune, Nykode Therapeutics, RAPT Therapeutics, among others. Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report shows that the 7MM market size is predicted to rise from USD 10.7 billion in 2024 at a significant CAGR by 2034 owing to the active participation of key companies, including Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, Tillotts Pharma (Zeria Pharmaceutical), Gilead Sciences, Galapagos NV, Boehringer Ingelheim, Celgene (Bristol Myers Squibb), Eli Lilly and Company, RedHill Biopharma, Arena Pharmaceuticals, Mesoblast, among others. Human Papillomavirus Market Human Papillomavirus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HPV companies, including Inovio Pharmaceuticals, ISA Pharmaceuticals, Regeneron Pharmaceuticals, Merck, Pattern Pharma, Nykode, Vaccibody A/S, among others. Human Papillomavirus Pipeline Human Papillomavirus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HPV companies, including Inovio Pharmaceuticals, ISA Pharmaceuticals, Regeneron Pharmaceuticals, Merck, Pattern Pharma, Nykode, Vaccibody A/S, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果免疫疗法临床3期上市批准

2023-11-17

·BioSpace

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.

快速通道临床结果临床2期放射疗法ASCO会议

2023-10-26

·BioSpace

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.

临床2期ASCO会议临床3期

100 项与卟啉锰相关的药物交易

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
高级别胶质瘤	临床3期	-	BioMimetix JV LLC	-
铂耐药性卵巢癌	临床2期	美国	BioMimetix JV LLC	2025-04-01
复发性子宫内膜癌	临床2期	美国	BioMimetix JV LLC	2025-04-01
直肠腺癌	临床2期	美国	BioMimetix JV LLC	2022-08-15
脑转移瘤	临床2期	美国	BioMimetix JV LLC	2022-08-10
头颈部肿瘤	临床2期	美国	BioMimetix JV LLC	2022-08-10
胶质母细胞瘤	临床2期	美国	BioMimetix JV LLC	2018-09-25
肛门鳞状细胞癌	临床2期	美国	BioMimetix JV LLC	2017-11-28
局部晚期恶性肿瘤	临床2期	美国	BioMimetix JV LLC	2017-04-19
头颈部鳞状细胞癌	临床2期	美国	BioMimetix JV LLC	2017-04-19

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02655601 (SNO2023) 人工标引	临床2期	高级别胶质瘤一线	160	BMX-001+RT+Temozolomide	鹽鏇餘夢憲衊觸糧淵鑰(蓋衊鹹顧餘鹹憲鏇鏇遞) = 鏇壓衊窪醖製獵範鬱鹽糧衊淵糧網艱鑰衊遞觸 (鏇膚簾壓積鑰遞範膚鹹, 21.6 ~ NR)	积极	2023-11-17
				RT+Temozolomide	鹽鏇餘夢憲衊觸糧淵鑰(蓋衊鹹顧餘鹹憲鏇鏇遞) = 鏇遞鏇蓋鹹鹹窪襯醖繭糧衊淵糧網艱鑰衊遞觸 (鏇膚簾壓積鑰遞範膚鹹, 19.6 ~ 32.6)
NCT02990468 (BMX-HN, CTgov)	临床1/2期	口咽部鳞状细胞癌 \| 头颈部鳞状细胞癌 \| 局部晚期恶性肿瘤 ... 更多	29	cisplatin (Phase 1: Group 1)	壓蓋鏇觸壓遞鹽憲餘製 = 壓積選廠築構築膚糧淵廠淵鏇遞選衊範遞膚築 (範鏇繭簾鹽鏇構壓糧艱, 艱膚齋艱蓋選製夢願繭 ~ 製築構簾蓋淵膚觸製齋) 更多	-	2023-03-15
				cisplatin (Phase 1: Group II)	壓蓋鏇觸壓遞鹽憲餘製 = 繭憲窪選網鏇齋遞獵鬱廠淵鏇遞選衊範遞膚築 (範鏇繭簾鹽鏇構壓糧艱, 窪憲鑰鹽選製構獵壓範 ~ 夢築鑰蓋製鏇窪繭選窪) 更多
ASTRO2019	N/A	高级别胶质瘤	-	BMX-001 28 mg loading dose and 14 mg subsequent dose	膚艱齋窪鑰願鏇夢遞鑰(餘選齋憲網鑰齋壓鏇窪) = grade 3, n=1 窪鹹顧願鬱壓製膚觸構 (獵衊艱製築膚鏇夢夢齋 ) 更多	-	2019-09-01
ACTR-28 (SNO2018)	临床1期	高级别胶质瘤	15	BMX-001 42 mg loading dose + 20 mg subsequent dose	壓壓鏇糧窪範襯鏇壓鬱(鬱衊範襯夢繭餘遞觸淵) = 鏇夢鏇築觸壓築製憲繭膚艱齋繭網醖醖選築獵 (積窪範齋糧壓廠壓襯鏇 )	积极	2018-11-05
				BMX-001 28 mg loading dose + 14 mg subsequent dose	壓壓鏇糧窪範襯鏇壓鬱(鬱衊範襯夢繭餘遞觸淵) = 鏇蓋顧憲選蓋獵築鏇廠膚艱齋繭網醖醖選築獵 (積窪範齋糧壓廠壓襯鏇 )