Pritumumab is a human IgG1 kappa antibody that binds to a malignant tumor associated antigen, ecto domain-vimentin (EDV) which is expressed in a variety of tumor cells. Pritumumab was shown to have relatively high reactivity with brain cancer cell lines, while no reactivity was demonstrated with normal neurons, astrocytes or fetal cerebral cells. Pritumumab has notable antibody-dependent cellular cytotoxicity (ADCC), brain tumor penetration and antitumor activity in nude mouse human xenograft models.
Primary Objectives
- To determine the safety and/or tolerability and the recommended Phase 2 dose (RP2D) of escalating, intravenously (IV) administered Pritumumab doses in patients with recurrent gliomas or with brain metastases.
Secondary Objectives
* To determine pharmacokinetics and pharmacodynamics of Pritumumab
* To identify preliminary signals of anti-tumor response to Pritumumab
* To explore disease-related, patient-reported outcomes

开始日期2021-02-22

申办/合作机构

Nascent Biotech, Inc.

[+1]

100 项与普立木单抗相关的临床结果

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100 项与普立木单抗相关的专利（医药）

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127

项与普立木单抗相关的文献（医药）

2024-11-01·Food Science & Nutrition

Encapsulation of Curcumin With Persian Gum and Its Application to the Production of Functional Yogurt: Physicochemical, Antioxidant, Sensory Properties, and Starter Bacteria Survival Study

Article

作者: Baghaei, Homa ; Taghadosi, Maziar ; Bolandi, Marzieh

ABSTRACT:

This study aimed to evaluate the ability of Persian gum to encapsulate curcumin and enhance its stability in dairy products. Given the increasing interest in functional foods, this study investigated the incorporation of nanocapsules containing curcumin (CLN) into functional stirred yogurt (CLN‐Y). CLN was prepared with Persian gum (PG) at different levels and included in the yogurt formula (CLN‐Y1%, CLN‐Y2%, and CLN‐Y3%). The physicochemical properties, rheological characteristics, antioxidant activity (AA), survival of starter bacteria, and sensory properties of the yogurt were evaluated over a 21‐day storage period at 4°C. The results showed that CLN significantly improved AA (reduction of 7.31% in the control vs. 1.85% in CLN‐Y3%), viscosity, hardness, and water holding capacity (reduction of 2.27% in control vs. 1.14% in CLN‐Y3%), while reducing syneresis (an increase of 10.87% in control vs. 3.16% in CLN‐Y3%) during storage (p < 0.05). CLN concentration directly affected AA. Although CLN‐Y exhibited a yellowish color and lower light intensity than the control, the samples were well accepted during storage. Increasing CLN levels led to decreased taste, color, and overall acceptance scores, and a 3% concentration is recommended for yogurt formulation due to its potential to improve yogurt quality, provide antioxidant benefits, maintain probiotic viability, and achieve high consumer acceptance during storage.

2024-09-01·DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Lymphatic targeting of cilnidipine by designing and developing a nanostructured lipid carrier drug delivery system

Article

作者: Meshram, Preeti Rajabhau ; Ranpise, Nisharani Sudhakar

OBJECTIVE:

The objective of current research is to design, develop, and optimize a cilnidipine (CLN) nanostructured lipid carrier (NLC)-based drug delivery system for the effective treatment of hypertension (HT).

SIGNIFICANCE:

Oral administration of CLN-loaded NLC (CLN NLC) containing glyceryl monostearate (GMS) as a solid and isopropyl myristate (IPM) as a liquid lipid may show remarkable lymphatic uptake through payer patches.

METHODS:

The emulsification probe sonication technique was used followed by optimization using 3² factorial designs.

RESULTS:

The optimized batch showed a mean particle size of 115.4 ± 0.22 nm with encapsulation efficiency of 98.32 ± 0.23%, polydispersity index (PDI) of 0.342 ± 0.03, and zeta potential (ZP, ζ) was -60.5 ± 0.24 which indicate excellent physical stability. In vitro studies showed a controlled release of CLN NLCs. Pharmacokinetics studies determined the C_max of NLCs (373.47 ± 15.1) indicates 2.3-fold enhancement compared with plain drug (160.64 ± 7.63). Pharmacodynamic studies indicated that CLN NLCs were maintaining systolic blood pressure in a controlled manner without any signs of side effects.

CONCLUSION:

CLN NLCs significantly improved lymphatic delivery and proved to be effective in the treatment and management of HT. It has been proved that CLN NLCs are found to be better than any traditional CLN dosage form due to enhancement in solubility, absorption, bioavailability, intestinal permeability, avoidance of first-pass metabolism, P-glycoprotein efflux and reduction in dose-related side effects, achievement of controlled and sustained release action.

2024-01-03·JOURNAL OF ANIMAL SCIENCE

Feeding or pen surface application of clinoptilolite with different particle sizes: impact on nitrogen utilization and manure ammonia emissions in feedlot cattle

Article

作者: Myers, Cheyanne A ; de Haro Marti, Mario E ; Chahine, Mireille ; Chibisa, Gwinyai E

Abstract:

This study investigated the effects of feeding clinoptilolite (CLN; 2.5% of diet dry matter) with a particle size of either 30- or 400-µm on ruminal fermentation characteristics, measures of nitrogen (N) utilization, and manure ammonia-N (NH3) emissions in feedlot cattle. The impact of directly applying 30- or 400-µm CLN to the pen surface (2,250 kg/ha) on manure NH3–N emissions was also evaluated. Six beef heifers were used in a replicated 3 × 3 Latin square design with 21-d periods. Dietary treatments were 1) finishing ration with no supplement (CON), 2) CON + 30-µm CLN (CLN-30), and 3) CON + 400-µm CL (CLN-400). Intake was measured daily. To evaluate fermentation characteristics, ruminal fluid was collected on day 19. Indwelling pH loggers were used to measure ruminal pH from days 15 to 21. Blood was collected 3-h post-feeding on day 21 for metabolite analysis. Fecal grab and urine spot samples were also collected from days 19 to 21 to measure nutrient digestibility, route of N excretion, and in vitro NH3 emissions. There was no diet effect (P ≥ 0.12) on nutrient intake and apparent total tract digestibility, and ruminal short-chain fatty acid profile and pH. Ruminal NH3 concentration, which was lower (P = 0.04) for CLN-30 than CON heifers, did not differ between CON and CLN-400 heifers. Although there was no diet effect (P = 0.50) on plasma urea-N (PUN) concentration, proportion of urea-N excreted in urine was lower (P = 0.01) for CLN-30 than CON and CLN-400 heifers. Urinary NH3–N excretion, which was greater (P ≤ 0.04) for CLN-400 than CON heifers, did not differ between CLN-30 and CLN-400 heifers. Feeding CLN also increased (P ≤ 0.02) fecal excretion of potassium (K) and iron (Fe) and reduced (P = 0.01) urinary excretion of calcium (Ca). There was a treatment × time interaction (P = 0.01) for NH3 emission rate, which was greatest within the first 36 h of incubation and was lower for manure from CLN-400 compared to CON and CLN-30 heifers and pen surface application treatments. Cumulative NH3 emissions were lower (P < 0.01) for manure from CLN-400 compared to CON and CLN-30 heifers and the pen surface application treatments. Although surface application was ineffective, feeding 400-µm CLN to finishing cattle could result in a beneficial decrease in manure NH3 emissions. However, changes in fecal and urine excretion of minerals like K and Ca, which suggest a decrease in bioavailability, need to be considered when feeding CLN in finishing cattle diets.

项与普立木单抗相关的新闻（医药）

2024-04-16

·BioSpace

Nascent Prepares for Pivotal Phase II Research with Fresh Manufacturing Run

NORTH PALM BEACH, FL / ACCESSWIRE / April 16, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies targeting various cancer types, announces that it is embarking on a fresh manufacturing run to ensure Pritumumab ("PTB") supplies are at maximum potency when patient dosing begins in the upcoming Phase II clinical trial. "Taking the time to navigate this opportunity with proper care and diligence is a step that demonstrates our commitment to the best interests of our investors, partners, shareholders, and potential future patients," remarked Sean Carrick, CEO of NBIO. "No one likes delays, but patience and care at this critical stage is necessary in maximizing patient outcomes and long-term shareholder value. We want to be careful not to make hasty decisions while exploring all options. This announcement comes as the Company prepares for a Phase II trial that follows a very successful Phase I trial-where safety at five ascending dose cohorts was observed-involving 15 patients who received PTB for various types of brain tumors. The most common and most challenging to treat tumor type in the trial was Glioblastoma. 12 of 15 patients had this diagnosis. There were no dose-related toxicities. Overall, the study found that single agent Pritumumab is safe up to a dose of 16.2 mg/kg every 7 days in brain tumor patients. One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study. Mr. Carrick continued, "Phase I demonstrated an excellent safety pro various doses. Phase II will be focused on clinical outcomes, and we are taking no shortcuts. We have been in discussions with potential Phase II study sites to ensure patients are being actively recruited and the most efficient process in place once we are ready to begin dosing." Management anticipates that some research sites will open for the start of Phase II testing late this summer with actual patients involved later in 2024. ABOUT NASCENT Nascent Biotech, Inc. (OTCQB:NBIO) is a phase 2 clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website . Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact Sean Carrick | President | CEO | Nascent Biotech, Inc. 772.713.0541 Cell | sean.carrick@nascentbiotech.com Public Relations EDM Media, LLC SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

临床2期临床结果临床1期

2024-03-19

·BioSpace

Nascent Collaborates With Hypospray Pharma on Proprietary Transdermal Delivery System

NORTH PALM BEACH, FL / ACCESSWIRE / March 19, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies targeting various cancer types, and HypoSpray Pharma ("HypoSpray®"), a clinical and commercial stage drug delivery technology company, announced today a collaboration to develop an alternative delivery mechanism for patients who can benefit from Pritumumab ("PTB"), Nascent's lead monoclonal antibody cancer treatment asset, which is now in Phase II clinical research for the treatment of Brain Cancer. Once successfully commercialized, the Company hopes to eliminate bi-weekly weekly infusions, allowing patients to administer Pritumumab and avoid inconvenient, tedious, and uncomfortable multi hour cancer center treatment visits. HypoSpray Pharma of Palm Beach Gardens FL has developed innovative technology for delivering active ingredients across the skin and mucosa. The company has a Drug Master File of record with the FDA for its delivery system, which enables measured application of a biological peptide to mucosal membranes or intact skin, promoting rapid absorption and bioavailability. Nascent CEO, Sean Carrick, commented: "We couldn't be more excited to work with HypoSpray's team and its leading delivery system technology. This collaboration has the potential to drive tangible breakthroughs in cancer treatment and patient care that enable home administration, eventually eliminating the need for bi-weekly multi-hour visits to the infusion center, materially improving quality of life for patients undergoing treatment." HypoSpray® Chairman and co-developer of the HypoSpray® technology, Kenneth Kirby, commented, "We are optimistic about our ability to enable effective delivery of Pritumumab. We have already successfully demonstrated our ability to accomplish similar objectives with several other peptides, including Melanocortin, Insulin, and Incretins, saving patients precious time and energy avoiding traditional infusion delivery." Cancer Drug researcher and Drug Delivery expert, Dr. Chandan Alam, formerly of the William Harvey Institute at the Royal London School of Medicine, said, "Our experience in multiple trials of the HypoSpray® DS technology with small molecules and peptides in pre-clinical trials has demonstrated its ability to rapidly deliver effective doses while enhancing blood-brain cross-over." Dr. William Kirsh, University of Miami Hospital Faculty and expert on End-of-life care, commented, "For patients with life-challenging illness, every minute counts. Eliminating hours of preparation, commuting, and the infusion process will be seen as a significant upgrade by GBM patients - for them, every hour is precious." ABOUT NASCENT Nascent Biotech, Inc. (OTCQB:NBIO) is a phase 2 clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website ABOUT HYPOSPRAY HypoSpray Pharma (Private) is clinical and commercial stage drug delivery technology company, enabling transdermal and transmucosal delivery of small molecules to peptides. The company has opened INDAs with FDA and MHRA and registered the HypoSpray DS as a Phase 4 Drug Master File. The technology provided in a cGMP form is available to licensed, compounding pharmacists to enable their practice. The company's technology is patented and patent pending. For further information please visit our website Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact: Sean Carrick | President | CEO | Nascent Biotech, Inc. 772.713.0541 Cell | sean.carrick@nascentbiotech.com Public Relations: EDM Media, LLC SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

临床2期

2024-02-06

·BioSpace

Nascent Biotech and Manhattan BioSolutions Collaborate to Explore Pritumumab Antibody-Drug Conjugates

NORTH PALM BEACH, FL and NEW YORK, NY / ACCESSWIRE / February 6, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies for the treatment of various cancers and viral infections, announced today it has entered into a research collaboration agreement with Manhattan BioSolutions, Inc. (Manhattan Bio), an emerging biotech company focused on precision biologics, to explore antibody-drug conjugates (ADCs) using Nascent's lead clinical candidate pritumumab (PTB) as the tumor-targeting antibody element. Pritumumab (PTB) is a natural human antibody. This monoclonal antibody targets extracellular form of vimentin, a protein that has been linked to cancer growth and metastasis and is overexpressed in both brain and pancreatic cancers as well as other hard tumor cancers. PTB is a targeted immunotherapy that binds to vimentin in tumors and recruits the immune system to eliminate cancer cells. PTB has demonstrated a promising safety pro preliminary efficacy in completed Phase I study in glioblastoma patients. Nascent has been recently cleared by the FDA to begin Phase II clinical trials for brain cancer. In preclinical experiments, PTB antibody has shown the capacity to cross the blood-brain barrier with the additional potential to transport conjugated drugs into brain tissues, and Nascent holds a patent covering this specialized delivery mechanism. Under the terms of the agreement, Manhattan Bio will perform PTB conjugations to industry standard linker-payloads and will evaluate the resulting ADCs in the in vitro cell assays. The most promising candidates will be prioritized for further development for the treatment of vimentin-positive and potential secondary targets in advanced or metastatic tumors. Nascent CEO, Sean Carrick, commented: "We are thrilled to unlock the full disruptive potential of pritumumab against cancer by collaborating with Manhattan Bio's world-leading scientists. This collaboration serves as an exciting first step in uncovering the possibilities of better targeted cancer therapies." "Pritumumab offers unexplored potential as an ADC vector, and we are excited to test that promise leveraging our expertise in ADC discovery and development. This could pave the way for applying our newest linker-payload innovations to pritumumab in the future" said Dr. Borys Shor, CEO of Manhattan Bio. About Nascent Biotech Nascent Biotech, Inc. (OTCQB:NBIO) is a clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. Its products are not yet commercially available. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 clinical trials for the treatment of Brain Cancer. For further information please visit our website . Forward Looking Safe Harbor Statement Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law. Corporate Contact: Sean Carrick sean.carrick@nascentbiotech.com About Manhattan BioSolutions Manhattan BioSolutions, Inc is a privately held biotechnology company focused on the development of biologic immunotherapies targeting host defense pathways for the treatment of advanced cancers. The company advances two technology platforms for drug discovery: RNA-degrader proteins, and antibody-drug conjugates (ADCs) - through collaborations with leading academic institutions. Manhattan Bio has established partnerships with the National Cancer Institute (NCI), Stony Brook University, The University at Buffalo, Binghamton University, INSERM, Nascent Biotech, EVQLV, and has been awarded grants by the National Institutes of Health (NIH), the National Science Foundation (NSF), the New Jersey Commission on Science, Innovation and Technology (CSIT), the New York State Center For Biotechnology and the University at Buffalo Center for Advanced Technology in Big Data and Health Sciences (UBCAT). Learn more at manhattanbiosolutions.com and follow Manhattan BioSolutions on LinkedIn or Twitter. Contact for investor inquiries: Borys Shor, Ph.D. ir@manhattanbiosolutions.com SOURCE: Nascent Biotech Inc. View the original press release on accesswire.com

临床2期免疫疗法引进/卖出临床1期抗体药物偶联物

100 项与普立木单抗相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
脑癌	临床2期	美国	Nascent Biotech, Inc.	2023-05-26
胶质瘤	临床2期	日本	Nascent Biotech, Inc.	2016-01-14
脑转移瘤	临床1期	美国	Nascent Biotech, Inc.	2021-02-22
新型冠状病毒感染	临床前	美国	Nascent Biotech, Inc.	2020-03-05
胰腺癌	临床前	美国	Nascent Biotech, Inc.	2018-01-23

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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


NCT04396717 (Biospace) 人工标引	临床1期	脑癌	15	Pritumumab	齋壓範艱網窪艱範築壓(壓遞網繭觸窪積齋淵鹽) = One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study. 簾繭製壓憲遞憲遞餘艱 (蓋鑰簾膚憲繭獵淵製簾 )	积极	2024-04-16
NCT04396717 (ASCO2023) 人工标引	临床1期	脑癌	15	pritumumab	鑰襯廠廠蓋觸願膚製餘(壓遞襯製憲顧衊鹽遞製) = fatigue (53.3%) and constipation (33.3%) 獵範積顧膚襯蓋鬱淵糧 (簾膚廠獵鏇窪繭窪窪繭 )	积极	2023-05-31
AACR2014	临床2期	脑癌	249	Pritumumab	醖膚選壓觸夢窪廠蓋膚(壓蓋製鏇鬱廠窪廠獵襯) = 廠鏇鏇選醖鏇襯鬱願糧繭蓋網壓願餘醖鏇壓窪 (夢窪醖夢衊餘淵衊壓壓 )	积极	2014-10-01