A Phase 1b Open-Label Study Investigating the Tolerability, Safety, and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma

This is a phase 1 open-label, multicenter study to investigate tolerability, safety and PK properties of oral OKN-007 in patients with recurrent high-grade glioma.

开始日期2023-04-17

申办/合作机构

Oblato, Inc.

NCT03649464

/ Withdrawn临床1/2期

A Phase Ib/2 Open-label Study Investigating the Tolerability, Safety, Pharmacokinetic Properties and Efficacy of Oral OKN-007 in Participants With Recurrent High-grade Glioma

The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK) and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.

开始日期2022-08-01

申办/合作机构

Oblato, Inc.

NCT04388475

/ Active, not recruiting临床2期

A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma

This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.

开始日期2020-06-12

申办/合作机构

Oblato, Inc.

100 项与地舒芬通钠相关的临床结果

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100 项与地舒芬通钠相关的转化医学

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100 项与地舒芬通钠相关的专利（医药）

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116

项与地舒芬通钠相关的文献（医药）

2023-09-17·bioRxiv : the preprint server for biology

Sulfatase 2 Inhibition Sensitizes Triple-Negative Breast Cancer Cells to Chemotherapy Through Augmentation of Extracellular ATP.

作者: Cherian, Mathew A ; Marcho, Lynn ; Manouchehri, Jasmine M

Background:

Breast cancer is the leading cause of cancer-related death among women worldwide. Patients diagnosed with triple-negative breast cancer (TNBC) have limited therapeutic options that produce durable responses. Hence, a diagnosis of TNBC is associated with a poor prognosis compared to other types of breast cancer. As a result, there is a critical need for novel therapies that can deepen and prolong responses.We previously found that chemotherapy causes the release of extracellular adenosine triphosphate (eATP). Augmenting eATP release can boost the response of TNBC cells to chemotherapy and cause increased cell death. However, eATP concentrations are limited by several families of extracellular ATPases, which complicates the design of compounds that attenuate eATP degradation.In this study, we hypothesized that heparan sulfate (HS) would inhibit extracellular ATPases and accentuate chemotherapy-induced cytotoxicity in TNBC by augmenting eATP. HS can be desulfated by sulfatase 1 and 2; sulfatase 2 is consistently highly expressed in a variety of cancers including breast cancer, whereas sulfatase 1 is not. We hypothesized that the sulfatase 2 inhibitor OKN-007 would exacerbate chemotherapy-induced eATP release and TNBC cell death.

Methods:

TNBC cell lines and nontumorigenic immortal mammary epithelial cells were treated with paclitaxel in the presence of heparan sodium sulfate and/or OKN-007; eATP content and cell viability were evaluated. In addition, protein and cell surface expression of sulfatases 1 and 2 were determined in all examined cell lines via ELISA, Western blot, and flow cytometry analyses.

Results:

Sulfatase 2 was highly expressed in TNBC cell lines and human breast cancer samples but not in immortal mammary epithelial cells and much less so in normal human breast tissue and ductal carcinoma in situ samples. OKN-007 exacerbated chemotherapy-induced eATP release and chemotherapy-induced TNBC cell death. When combined with chemotherapy, OKN-007 attenuated cells with a cancer-initiating cell phenotype.

Conclusions:

These results suggest that sulfatase 2 inhibitors in combination with chemotherapy attenuate the viability of TNBC cells more than chemotherapy alone by exacerbating eATP release. These effects, as well as their capacity to attenuate the cancer-initiating cell fraction, may translate into combination therapies for TNBC that induce deeper and more durable responses.

2023-01-01·The international tinnitus journal

Response to OKN-007 and NAC in a Patient with Unilateral Hearing Loss and Chronic Tinnitus from Vestibular Schwannoma

作者: Nguyen, Minhdan ; Kesari, Santosh ; Kopke, Richard D ; Sharma, Akanksha ; Griffiths, Chester ; Gill, Jaya M ; Juarez, Tiffany ; Frazer, Gregory ; Zats, Max ; Wagle, Naveed ; Liu, Andy ; Kang, Shinwook ; Nersesian, Raffi ; Truong, Judy ; Chacon, Emma ; West, Matthew B

BACKGROUND:

Tinnitus is the perception of sound in the absence of external acoustic stimulation. Being one of the most common diseases of the ear, it has a global prevalence ranging from 4.1 to 37.2%. To date, it has been difficult to treat tinnitus as its pathophysiology is poorly understood and there are limited treatment options.

OBJECTIVE:

To investigate the effect of OKN-007 (also known as HPN-07), a nitrone-based investigational drug, in combination with oral N-acetylcycsteine (NAC), for the treatment of hearing loss and chronic tinnitus under an individual expanded access protocol.

PATIENT CASE:

We report the case of a patient who presented with left-sided ear fullness, mild tinnitus, and mild high frequency sensorineural hearing loss with 100% word recognition. A large enhancing mass seen on MRI revealed a vestibular schwannoma. He underwent subtotal resection of the tumor resulting in a moderate-to-profound sensorineural hearing loss and catastrophic tinnitus. The patient was treated with intravenous OKN-007 at 60 mg/kg dosed three times per week and oral NAC 2500 mg twice daily.

RESULTS:

Post-treatment audiometric testing revealed an average of 16.66 dB in hearing threshold improvement in three frequencies (125, 250 and 500 Hz) with residual hearing in the affected left ear. His tinnitus loudness matching improved from 90 dB to 19 dB post-treatment. His Tinnitus Handicap Inventory improved from 86/100 (Catastrophic) to 40/100 (Moderate). He also experienced improvements in sleep, concentration, hearing, and emotional well-being, and reported significantly decreased levels of tinnitusrelated distress.

CONCLUSIONS:

This case report highlights the feasibility and therapeutic potential of the combination of OKN-007 and NAC in treating hearing loss and tinnitus that warrants further investigation.

2022-10-01·Toxicological research

Neuroprotective efficacy of N-t-butylhydroxylamine (NtBHA) in transient focal ischemia in rats

Article

作者: Kim, Eun-Hye ; Shin, Yusun ; De Felice, Milena ; Kim, Donghyun ; Kim, Eun-Sun ; Majid, Arshad ; Bae, Ok-Nam

The pharmacological or toxicological activities of the degradation products of drug candidates have been unaddressed during the drug development process. Ischemic stroke accounts for 80% of all strokes and is responsible for considerable mortality and disability worldwide. Despite decades of research on neuroprotective agents, tissue plasminogen activators (t-PA), a thrombolytic agent, remains the only approved acute stroke pharmacological therapy. NXY-059, a free radical scavenger, exhibited striking neuroprotective properties in preclinical models and met all the criteria established by the Stroke Academic Industry Roundtable (STAIR) for a neuroprotective agent. In phase 3 clinical trials, NXY-059 exhibited significant neuroprotective effects in one trial (SAINT-I), but not in the second (SAINT-II). Some have hypothesized that N-t-butyl hydroxylamine (NtBHA), a breakdown product of NXY-059 was the actual neuroprotective agent in SAINT-I and that changes to the formulation of NXY-059 to prevent its breakdown to NtBHA in SAINT -II was the reason for the lack of efficacy. We evaluated the neuroprotective effect of NtBHA in N-methyl-D-aspartate (NMDA)-treated primary neurons and in rat focal cerebral ischemia. NtBHA significantly attenuated infarct volume in rat transient focal ischemia, and attenuated NMDA-induced cytotoxicity in primary cortical neurons. NtBHA also reduced free radical generation and exhibited mitochondrial protection.

项与地舒芬通钠相关的新闻（医药）

2023-09-19

·BioSpace

CorriXR Therapeutics Announces Deborah Moorad as Its New Chief Executive Officer

NEWARK, Del.--(BUSINESS WIRE)-- CorriXR Therapeutics, Inc., an oncology-focused biotherapeutics company developing breakthrough technology that overcomes drug resistance in solid tumors, announced that Deborah Moorad, MBA, has been named the company’s new chief executive officer. Moorad, who previously served as CEO of Nature Technology Corp., and is an Entrepreneur-in-Residence at Cortado Ventures, succeeds co-founder Eric B. Kmiec, Ph.D., who has been appointed chief scientific officer. This press release features multimedia. View the full release here: Deborah Moorad, CEO of CorriXR Therapeutics, Inc. (Photo: Business Wire) Moorad has a proven track record of creating and implementing strategies that bridge the gap between benchtop and bedside, leading global cross-functional teams and developing commercial partnerships that have resulted in broader access to cancer therapies. Under her leadership, Nature Technology Corp., whose technology is used by leading pharmaceutical/biotechnology companies, as well as nearly every contract development and manufacturing organization (CDMO) in the gene therapy/genomic medicine space, was acquired in a record multiplier transaction by Aldevron, a Danaher Company. Moorad also led a repurposed drug (OKN-007) from animal studies to clinical trial for glioblastoma multiforme. OKN-007 was later acquired and patients are still being treated using this therapy. “I’m excited to bring my perspective to an exceptional team of scientists and business leaders,” says Moorad. “In its short history, CorriXR has already managed to establish itself as a pioneering force in genomic medicine, and I look forward to driving us even further forward. Together, we’re going to work diligently to bring this transformative CRISPR technology into the world of cancer care, providing new hope to individuals fighting this disease, and changing the paradigm of care for people living with cancer.” Moorad joins CorriXR at a critical juncture as the company recently closed its seed funding round and will be launching its Series A financing round later this year. CorriXR is utilizing its patented gene editing technology to augment and improve the current standard of cancer care by overcoming drug resistance in solid tumors. The initial clinical indications will be squamous cell carcinoma of the lung, esophagus and head and neck, as well as glioma. The company owes its success thus far to a close collaboration with the Gene Editing Institute, ChristianaCare’s nonprofit research institute and the first of its kind to emerge from a community health system. “I’m confident that CorriXR will thrive under the guidance of Deborah Moorad, and her work will continue to drive forward the development of life-changing treatments utilizing our novel gene editing technology, which presents an enormous opportunity to impact health and revolutionize patient care,” said Janice Nevin, M.D., CEO of ChristianaCare and chair of CorriXR’s board of directors. "We are grateful to Dr. Kmiec for leading the company during the start-up phase and through this planned transition.” “We are thrilled to welcome Deborah Moorad as our new CEO,” says Kmiec. “Her proven experience in the biotechnology arena and transformative approach to business will undoubtedly steer CorriXR to further success in translating our work at the lab bench into care for patients. I look forward to working with her to advance our platform to the clinic.” About CorriXR Therapeutics: CorriXR Therapeutics, Inc. is an oncology-focused biotherapeutics development company enabled by a novel IP-protected in vivo gene editing platform technology. The company is developing genetic medicine to augment and improve the current standard of cancer care by overcoming drug resistance in solid tumors. These biotherapeutics are designed to extend the effectiveness and lifespan of existing therapies. The company is the inaugural biotech spin-out of ChristianaCare, a large mid-Atlantic healthcare system and the Gene Editing Institute, which has been embedded in ChristianaCare’s Helen F. Graham Cancer Center & Research Institute since 2015. For further information, please visit . View source version on businesswire.com: Contacts Jennifer Kmiec, Chief of Staff CorriXR Therapeutics, Inc. 302-689-3032 jkmiec@corrixr.com Source: CorriXR Therapeutics, Inc. Smart Multimedia Gallery Photo Deborah Moorad, CEO of CorriXR Therapeutics, Inc. (Photo: Business Wire) Logo View this news release and multimedia online at:

并购高管变更基因疗法

2023-05-01

·PRNewswire

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

临床3期临床2期疫苗免疫疗法

2023-04-23

·PRNewswire

Oblato Announces the First Enrollment in a Phase 1 Clinical Trial for an Oral Formulation of OKN-007 in Recurrent High-Grade Glioma Patients in the USA

PRINCETON, N.J., April 21, 2023 /PRNewswire/ -- Oblato, Inc. (the Company), a subsidiary company of HLB Therapeutics in Korea, has announced today the first enrollment for recurrent high-grade glioma patients in a Phase 1 clinical trial in the USA with an oral formulation of its proprietary compound OKN-007. This is the first step using oral OKN-007 in glioblastoma clinical trials. Along with the ongoing clinical development of an injectable formulation, this Phase 1 trial is expected to broaden the possibility of a new drug approval for the treatment of glioblastoma, a rare and deadly disease. The Company has been developing oral formulation of OKN-007 which have many advantages, including greater convenience for the patients, continuous exposure of drugs to the body, and flexibility in development when expanding indications to other cancer types. A total of four hospitals, including Providence Saint John's Cancer Institute and Norton Healthcare, are participating in the clinical trial. A dose escalation and pharmacokinetic analysis will be investigated in the trial. The Company will determine the dose of OKN-007 oral formulation to be used in future clinical development by integrating the safety and preliminary efficacy results from this study. In addition, the Company is also conducting a Phase 2 clinical trial with recurrent glioblastoma multiforme (GBM) patients using a combination therapy of OKN-007 injectable formulation and temozolomide at thirteen institutions, including Henry Ford Health System. Patient enrollment was completed in October, 2022 and some patients are still being treated and follow-up for survival status is continuing. Regarding the development of OKN-007 as a new anti-cancer drug, Ki Hong Ahn, CEO of the Company, stated, "We have decided to develop an oral formulation in consideration of convenience for the patient, which is an important aspect for future commercialization, and plan to have a strategy to increase the value of the new drug in the market with great unmet needs through diversification of treatment options. Through discussions with the FDA, we have already incorporated their suggestions on the clinical study protocol. Along with investigating the efficacy in existing clinical studies with the OKN injectable formulation, our plan for this Phase 1 clinical trial is to determine the safety of an oral dosage form of OKN-007 and define a dose for further clinical trials, thus allowing multiple options for future development". About Oblato, Inc. Oblato, Inc. (Oblato or the Company), a wholly-owned subsidiary of the Korean biotech company, HLB Therapeutics, is incorporated in Delaware, and has its principal place of business in New Jersey. Since 2016, the Company has been developing a new drug, OKN-007, to treat brain cancers, especially glioblastoma multiforme (GBM) as a rare disease and diffuse intrinsic pontine glioma (DIPG) as a rare pediatric disease. Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with newly diagnosed and recurrent GBM, respectively. The Company has just started the enrollment of patients with recurrent high-grade glioma in a Phase 1 clinical study with an OKN-007 oral formulation. Oblato has received both rare pediatric disease and fast track designations for DIPG. For additional information about Oblato, please visit . CONTACT: For Oblato: [email protected] SOURCE Oblato, Inc.

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100 项与地舒芬通钠相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
短暂性脑缺血发作	临床3期	美国	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	中国	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	阿根廷	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	澳大利亚	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	奥地利	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	比利时	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	巴西	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	保加利亚	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	加拿大	AstraZeneca PLC	2003-05-01
短暂性脑缺血发作	临床3期	智利	AstraZeneca PLC	2003-05-01

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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


NCT04388475 (AACR2024) 人工标引	临床2期	复发性恶性胶质瘤	57	OKN-007 + Temozolomide	艱選繭觸網襯鏇鬱遞齋(餘網窪構遞膚積蓋鏇構) = 網淵積網襯鏇淵廠遞鏇淵製鬱顧願鹹壓壓顧衊 (壓壓繭鹹鹹艱齋齋鏇糧 ) 更多	积极	2024-04-05
				Lomustine	膚夢願餘醖簾窪鏇憲蓋(構餘構觸遞廠壓鹽齋憲) = 憲築願廠窪鏇製顧選繭鏇齋憲獵獵鹹觸膚餘鬱 (鬱鬱遞獵製艱網獵壓遞, 6.8 ~ 7.8) 更多
NCT01672463 (CTNI-39, SNO2020)	临床1期	复发性恶性胶质瘤	-	OKN-007 20 mg/kg	窪憲衊網蓋簾艱鏇齋簾(繭積觸夢蓋構齋網觸廠) = 1.6% 選齋淵簾築襯糧壓餘構 (鑰夢窪膚膚願淵獵襯膚 ) 更多	积极	2020-11-09
				OKN-007 60 mg/kg
NCT01672463 (ASCO 12020 \| ASCO 22020) 人工标引	临床1期	脑恶性胶质瘤	15	OKN-007	製願鏇構構壓鏇齋餘鏇(繭獵繭願齋齋襯構鬱築) = Grade 3 TEAE included headache, urinary tract infection, and increased prothrombin time (0.8% each). 壓膚遞鹽築窪鏇鹹願製 (廠製衊襯積廠艱糧築築 )	积极	2020-05-29
				OKN-007
NCT00119626 (SAINT I, Pubmed \| N Engl J Med)	临床3期	急性缺血性卒中	1,722	NXY-059	壓膚衊簾願鏇壓簾夢糧(鹽蓋簾顧餘範築築築蓋): common odds ratio = 1.2 (95% CI, 1.01 ~ 1.42), P-Value = 0.038	积极	2006-02-09
				Placebo
SFN2003	N/A	-	-	NXY-059	鬱簾鑰憲鏇網衊廠鑰蓋(鹽鹹築願膚艱窪選願淵) = 醖築夢網鹽餘獵醖範鏇壓築鹽艱廠襯廠膚醖範 (獵廠壓壓糧襯構衊簾製, 0.45)	-	2003-11-08
				Combination of NXY-059 and TNK	鬱簾鑰憲鏇網衊廠鑰蓋(鹽鹹築願膚艱窪選願淵) = 廠蓋範網積齋繭蓋築選壓築鹽艱廠襯廠膚醖範 (獵廠壓壓糧襯構衊簾製 )