A Phase II, Single-arm, Open-label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

This study evaluates the efficacy and safety of PBI-05204, an extract of the leaves of Nerium oleander, in patients with Stage IV metastatic pancreatic cancer. All patients will receive PBI-05204.

Start Date01 Apr 2015

Sponsor / Collaborator

Phoenix Biotechnology, Inc.

100 Clinical Results associated with Phoenix Biotechnology, Inc.

0 Patents (Medical) associated with Phoenix Biotechnology, Inc.

Literatures (Medical) associated with Phoenix Biotechnology, Inc.

15 Jun 2022·Cancer Research

Abstract 6307: The botanical drug PBI-05204, a supercritical CO₂ extract of Nerium oleander, augments the antitumor efficacy of radiotherapy in treatment of human glioblastoma

Author: Rosetti, Alessandra ; Gravina, Giovanni Luca ; Mancini, Andrea ; Martellucci, Stefano ; Newman, Robert ; Festuccia, Claudio ; Mattei, Vincenzo ; Vital, Flora ; Marampon, Francesco ; Colapietro, Alessandro ; Yang, Peiying

AbstractGlioblastoma multiforme (GBM) is the most common as well as one of the most malignant types of brain cancer. Despite progress in development of novel therapies for the treatment of GBM, it remains largely incurable with a poor prognosis and a very low life expectancy. Recent studies have shown that oleandrin, a unique cardiac glycoside from Nerium oleander, as well as defined extract (PBI-05204) that contains this molecule, inhibit growth of human glioblastoma, and modulate glioblastoma patient-derived stem cell-renewal properties. The present study aimed to investigate the radiosensitization of PBI-05204 in glioblastoma using both in vitro and in vivo cancer models as well as to explore the potential mechanism of actions in GBM. The radiosensitizing effect of PBI-05204 was assessed against human GBM U87MG, U251, T98G and A172 cell lines as well as their relevant xenograft and orthotopic models. The induction of apoptosis, DNA damage and repair of DNA double strand breaks were assessed with determination of caspase 3 and 9 protein expression, DNA laddering, protein expression of rH2AX, Ku70, DNA-PKcs, and RAD51 as well as a Comet Assay. PBI-05204 treatment leads to an increased in vitro sensitivity of GBM cells, including U87MG, U251, T98G and A172 cells, to radiotherapy (RT) in which the main mechanisms are the transition from autophagy to apoptosis and enhanced DNA damage evidenced by increased expression of γH2AX. Additionally, relative increased expression of Ku70, DNA-PKcs and RAD51 due to RT were reduced by PBI-05204 in U87MG and U251 cells, suggesting PBI-05204 lessened RT mediated DNA repair. PBI-05204 significantly enhanced the RT mediated inhibition of tumor growth by 4.7-, 2.1- and 2.2-fold in U87MG, U251 and T98G xenograft models, respectively. The combination of RT and PBI-05204 showed a significantly enhancement of disease-free survival to 103.0 ± 63.2 days compared to the control group (p < 0.001) which was 3-fold longer than that of RT only group. Collectively, these results reveal that PBI-05204 enhances antitumor activity of RT in preclinical/murine models of human GBM. Given the fact that PBI-05204 has already been examined in Phase I and II clinical trials for cancer patients, its efficacy when combined with standard-of-care radiotherapy regimens in GBM should be explored in future clinical trials of this difficult to treat brain cancer.Citation Format: Alessandro Colapietro, Peiying Yang, Alessandra Rosetti, Andrea Mancini, Flora Vital, Stefano Martellucci, Francesco Marampon, Vincenzo Mattei, Giovanni Luca Gravina, Robert Newman, Claudio Festuccia. The botanical drug PBI-05204, a supercritical CO₂ extract of Nerium oleander, augments the antitumor efficacy of radiotherapy in treatment of human glioblastoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 6307.

01 Jan 2022·Antiviral Chemistry and Chemotherapy

Efficacy of oleandrin and PBI-05204 against bovine viruses of importance to commercial cattle health

Article

Author: Buterbaugh, Robin ; Van Holland, Sonja ; Woolum, Amelia ; Matos, Jose R. ; Jagannadha Sastry, K ; Abdelaal, Hadia ; Chase, Christopher C.L. ; Abdelsalam, Karim ; Newman, Robert A.

Background Bovine viral diarrhea virus (BVDV), bovine respiratory syncytial virus (BRSV). and bovine coronavirus (BCV) threaten the productivity of cattle worldwide. Development of therapeutics that can control the spread of these viruses is an unmet need. The present research was designed to explore the in vitro antiviral activity of the Nerium oleander derived cardiac glycoside oleandrin and a defined N. oleander plant extract (PBI-05204) containing oleandrin. Methods Madin Darby Bovine Kidney (MDBK) cells, Bovine Turbinate (BT) cells, and Human Rectal Tumor-18 (HRT-18) cells were used as in vitro culture systems for BVDV, BRSV and BCV, respectively. Cytotoxicity was established using serial dilutions of oleandrin or PBI-05204. Noncytotoxic concentrations of each drug were used either prior to or at 12 h and 24 h following virus exposure to corresponding viruses. Infectious virus titers were determined following each treatment. Results Both oleandrin as well as PBI-05204 demonstrated strong antiviral activity against BVDV, BRSV, and BCV, in a dose-dependent manner, when added prior to or following infection of host cells. Determination of viral loads by PCR demonstrated a concentration dependent decline in virus replication. Importantly, the relative ability of virus produced from treated cultures to infect new host cells was reduced by as much as 10,000-fold at noncytotoxic concentrations of oleandrin or PBI-05204. Conclusions The research demonstrates the potency of oleandrin and PBI-05204 to inhibit infectivity of three important enveloped bovine viruses in vitro. These data showing non-toxic concentrations of oleandrin inhibiting infectivity of three bovine viruses support further investigation of in vivo antiviral efficacy.

01 Jun 2021·Biomedicine & PharmacotherapyQ2 · MEDICINE

Antiviral activity of oleandrin and a defined extract of Nerium oleander against SARS-CoV-2

Q2 · MEDICINE

Article

Author: Sastry, K Jagannadha ; Aguilar, Patricia V ; Torrelles, Jordi B ; Tamayo, Paula Pino ; Park, Jun-Gyu ; Dwivedi, Varun ; Matos, Rick ; Weaver, Scott C ; Shivanna, Vinay ; Bopp, Nathen ; Plante, Jessica A ; Newman, Robert A ; Mirchandani, Divya ; Plante, Kenneth S ; Martinez-Sobrido, Luis ; Delgado, Jennifer ; Fernandez, Diana

With continued expansion of the coronavirus disease (COVID-19) pandemic, caused by severe acute respiratory syndrome 2 (SARS-CoV-2), both antiviral drugs as well as effective vaccines are desperately needed to treat patients at high risk of life-threatening disease. Here, we present in vitro evidence for significant inhibition of SARS-CoV-2 by oleandrin and a defined extract of N. oleander (designated as PBI-06150). Using Vero cells, we found that prophylactic (pre-infection) oleandrin (as either the pure compound or as the active principal ingredient in PBI-06150) administration at concentrations as low as 0.05 µg/ml exhibited potent antiviral activity against SARS-CoV-2, with an 800-fold reduction in virus production, and a 0.1 µg/ml concentration resulted in a greater than 3000-fold reduction in infectious virus production. The half maximal effective concentration (EC₅₀) values were 11.98 ng/ml when virus output was measured at 24 h post-infection, and 7.07 ng/ml measured at 48 h post-infection. Therapeutic (post-infection) treatment up to 24 h after SARS-CoV-2 infection of Vero cells also reduced viral titers, with 0.1 µg/ml and 0.05 µg/ml concentrations causing greater than 100-fold reduction as measured at 48 h, and the 0.05 µg/ml concentration resulting in a 78-fold reduction. Concentrations of oleandrin up to 10 µg/ml were well tolerated in Vero cells. We also present in vivo evidence of the safety and efficacy of defined N. oleander extract (PBI-06150), which was administered to golden Syrian hamsters in a preparation containing as high as 130 µg/ml of oleandrin. In comparison to administration of control vehicle, PBI-06150 provided a statistically significant reduction of the viral titer in the nasal turbinates (nasal conchae). The potent prophylactic and therapeutic antiviral activities demonstrated here, together with initial evidence of its safety and efficacy in a relevant hamster model of COVID-19, support the further development of oleandrin and/or defined extracts containing this molecule for the treatment of SARS-CoV-2 and associated COVID-19 disease and potentially also for reduction of virus spread by persons diagnosed early after infection.

News (Medical) associated with Phoenix Biotechnology, Inc.

19 Apr 2021

·www.biospace.com

Awakn Life Sciences Inc. Announces Two Key Appointments to Its Board of Directors

Toronto, Ontario--(News - April 19, 2021) - Awakn Life Sciences Inc. (Awakn), a biotechnology company with clinical operations researching, developing, and delivering psychedelic medicine to treat addiction, announced today the appointment of Stephen Page and Professor John Papastergiou as independent non-executive directors to the Company's Board of Directors. Adding significant pharmaceutical and healthcare sector experience and independent board governance to Awakn. Stephen Page has worked in executive and Board of Director roles in the UK healthcare industry for over 30 years, most notably leading Priory Healthcare, the largest network of mental healthcare hospitals and clinics in the UK, through a period of rapid expansion and market dominance. He has led and successfully grown organizations in both public and private sectors including Oxleas NHS Trust in London (which focused on mental health), Nestor plc and Acorn Care and Education. As founding CEO of Acorn Care and Education, and supported by Phoenix Equity Partners, Steve built the company via acquisition and organic growth to be a leading national provider of special needs education and foster care. He led the sale to the Ontario Teachers' Pension Plan in 2010. Professor Papastergiou is an experienced pharmacist and clinical research scientist who has served as an advisor to several leading pharmaceutical organizations including Bayer, Pfizer, GSK, and AstraZeneca. His innovative research in point-of-care diagnostic testing and pharmacogenomics has led to the development and advancement of several tech start-up companies of which he also served as a board director. Professor Papastergiou holds Faculty appointments at the schools of Pharmacy at the University of Toronto and the University of Waterloo. In 2019, he was named by the International Forum on Advancement of Healthcare as one of the top 100 healthcare leaders globally and was also presented with the Ontario Pharmacists' Association Award for Excellence in Research and Academia. "We are pleased to welcome both Steve and John's significant experience and independent governance to our Board of Directors at this next stage of Awakn's evolution," said George Scorsis, Awakn's Chairman. "Both are highly respected and have extensive experience in up-scaling fast-growing companies in the mental health and biotechnology sectors, respectively. We look forward to their assistance in guiding us towards our objectives to develop and deliver psychedelics and psychedelic-assisted psychotherapy to radically change mental health services and deliver significantly better patient outcomes." Media enquiries: ROAD Communications Paul Jarman (paul@roadcommunications.co.uk) Anna Ramsey (anna@roadcommunications.co.uk) Investor enquiries: KCSA Strategic Communications Valter Pinto (Valter@KCSA.com) Tim Regan (TRegan@KCSA.com) About Awakn Life Sciences Inc. Awakn Life Sciences is a biotechnology company with clinical operations researching, developing, and delivering psychedelic medicine to treat Addiction. Awakn is integrating psychedelic medicine into mainstream healthcare through Research, Digital, Clinics, and Ecosystems. | Twitter | LinkedIn To view the source version of this press release, please visit

Acquisition

17 Mar 2021

·www.biospace.com

New Study Presents Evidence of Effectiveness and Safety Of Oleandrin and Phoenix Biotechnology’s PBI-06150 Against SARS-CoV-2

March 17, 2021 10:00 UTC SAN ANTONIO--(BUSINESS WIRE)-- An article published last week in the Journal of Biomedicine & Pharmacotherapy ( ; Vol 138 (2021) 111457) presents in vitro evidence for significant inhibition of SARS-CoV-2 by oleandrin and a defined extract of N. oleander (developed by Phoenix Biotechnology, Inc. and designated as PBI-06150), as well as in vivo evidence of the safety and efficacy of PBI-06150. This press release features multimedia. View the full release here: The Journal of Biomedicine & Pharmacotherapy is an open access, peer-reviewed medical journal covering medical applications of pharmacology. It was established in 1956 and is published 10 times a year. The authors of the article titled “Antiviral activity of oleandrin and a defined extract of Nerium oleander against SARS-CoV-2” state, “The potent prophylactic and therapeutic antiviral activities demonstrated here, together with initial evidence of its safety and efficacy in a relevant hamster model of COVID-19, support the further development of oleandrin and/or defined extracts containing this molecule for the treatment of SARS-CoV-2 and associated COVID-19 disease and potentially also for reduction of virus spread by persons diagnosed early after infection.” They further state, “With continued expansion of the coronavirus (COVID-19) pandemic, caused by severe acute respiratory syndrome 2 (SARS-CoV-2), both antiviral drugs as well as effective vaccines are desperately needed to treat patients at high risk of life-threatening disease . . . Moreover, it is possible that vaccines may require continuous development due to the ongoing mutation of coronavirus into different variants . . . Furthermore, except for Remdesivir, many of the existing antiviral drugs tested to date have shown limited or no efficacy in clinical trials. Thus, identification of safe and effective therapeutic agents that can be effective against SARS-CoV-2 remains an unmet need.” The article is a collaborative effort which covers the results of two separate studies of the impact of oleandrin and PBI-06150 on SARS-CoV-2. The in vitro study was conducted by scientists at the University of Texas Medical Branch (UTMB) in Galveston, while researchers at Texas Biomedical Research Institute (Texas Biomed) in San Antonio conducted the in vivo study, utilizing golden Syrian hamsters. Both studies were sponsored by Phoenix Biotechnology ( ). The in vitro study, using Vero cells, found that “prophylactic (pre-infection) oleandrin (as either the pure compound or as the active principal ingredient in PBI-06150) administration at concentrations as low as 0.05 μg/ml exhibited potent antiviral activity against SARS-CoV-2, with an 800-fold reduction in virus production, and a 0.1 μg/ml concentration resulted in a greater than 3000-fold reduction in infectious virus production. The half maximal effective concentration (EC50) values were 11.98 ng/ml when virus output was measured at 24 hours post-infection, and 7.07 ng/ml measured at 48 hours post-infection.” “Therapeutic (post-infection) treatment up to 24 h after SARS-CoV-2 infection of Vero cells also reduced viral titers, with 0.1 μg/ml and 0.05 μg/ml concentrations causing greater than 100-fold reduction as measured at 48 hours, and the 0.05 μg/ml concentration resulting in a 78-fold reduction. Concentrations of oleandrin up to 10 μg/ml were well tolerated in Vero cells.” In the in vivo study, the authors state, “We also present in vivo evidence of the safety and efficacy of defined N. oleander extract (PBI-06150), which was administered to golden Syrian hamsters in a preparation containing as high as 130 μg/ml of oleandrin. In comparison to administration of control vehicle, PBI-06150 provided a statistically significant reduction of the viral titer in the nasal turbinates (nasal conchae).” This journal article follows a November article in the Journal of Experimental Pharmacology which was titled “Antiviral Effects of Oleandrin” and reviewed a series of research studies which establish the antiviral activity of oleandrin, in particular oleandrin’s strong antiviral activity against “enveloped” viruses and its ability to inhibit production of infectious virus particles when used for treatment prior to, as well as after, infection of SARS-CoV-2. That article states, “The ability of oleandrin to inhibit the relative infectivity of progeny virus particles may offer a unique approach to treating certain viral diseases.” It further stated “The therapeutic potential of oleandrin and extracts containing this unique molecule against a wide variety of ‘enveloped’ viruses is evident from the preclinical studies reviewed in this article . . . The speed of development and international spread of viruses such as SARS-CoV-2 necessitates consideration of a new strategy against these viruses . . . Having a compound or plant extract with significant demonstrated potential to prevent as well as treat a wide variety of viruses deserves serious consideration.” About Phoenix Biotechnology, Inc. Phoenix Biotechnology, Inc., headquartered in San Antonio, has been exploring the health-related benefits of oleandrin, a novel extract of Nerium oleander for more than 20 years. Research was initiated at the University of Texas MD Anderson Cancer Center for the potential use of this extract against cancer. The company’s research led to the development of a proprietary supercritical CO2 extract of Nerium oleander into a new botanical drug – PBI-05204. Extensive research has also been undertaken to determine the efficacy of oleandrin/PBI-05204 as a therapy for neurodegenerative disease as well as viral infections. One of the profound discoveries of the research program is that a key component of this PBI product crosses the blood brain barrier, opening up the possibility of treatment in the areas of cancer, neurodegenerative diseases and as an antiviral product not currently available from any other known drug. PBI-05204 has been granted an IND through initial FDA review for Phase I and Phase II clinical oncology trials which were conducted in the United States. These trials have shown that this oral formulation is safe for administration to patients without severe toxicity or adverse effects. In response to the COVID-19 pandemic, the company focused research in 2020 on a potential treatment for this coronavirus. This effort resulted in two submissions to the FDA, one for a nutraceutical and the second for a pharmaceutical product. Preliminary discussions with the FDA have resulted in the request for additional studies to explore both efficacy and safety. These required trials should be completed within the next several months and, assuming the results are positive, we will pursue new applications for both products. View source version on businesswire.com: Contacts news@phoenixbiotechnology.com Source: Phoenix Biotechnology, Inc. Smart Multimedia Gallery Document Biomedicine & Pharmacotherapy Article: "Antiviral activity of oleandrin and a defined extract of Nerium oleander against SARS-CoV-2" Logo View this news release online at:

VaccineCollaborate

26 Apr 2012

·www.bioportfolio.com

Malvern foundations in rheology web seminars now available in eight languages

26 April 2012: Malvern, UK: In support of expanding global demand, materials characterization company Malvern Instruments is rapidly increasing its provision of multilanguage webcasts. In the latest posting, researchers across the world can now download a two-part foundation presentation covering rheology principles and applications, in eight different languages! Rheology explained part 1 - Flow and viscosity, and Rheology explained part 2 - Oscillation & viscoelasticity, can be accessed via the Malvern website at www.malvern.com/rheology-presentations These two presentations take the viewer through the basics of rheology from a measurement and application-focussed perspective, providing an overview of the rheological definitions, test methods and resultant data – all of which is directly applicable across various industries. The web seminars are available in English, French, German, Spanish, Italian, Dutch, Russian and Polish. www.malvern.com/rheology-presentations Malvern and Malvern Instruments are registered trademarks of Malvern Instruments Ltd Ends High resolution image attached or available from Luke Newman, Kapler Communications luke.newman@kapleronline.com Ref: M MAL/JOB/2292 CAPTION: Rheology from an industrial perspective About Malvern Instruments Malvern Instruments is a market leader in measuring performance controlling material properties. These include particle size, particle shape, zeta potential, molecular weight, size and conformation, rheological properties and chemical identification. Malvern delivers the systems, support and expertise that ensure the analytical integrity and productivity needed to drive research, development and manufacturing. Malvern’s measurement solutions for scientists, technologists and engineers advance continually through customer collaboration. Complementary materials characterization systems deliver inter-related measurements that reflect the complexities of particulates and disperse systems, nanomaterials and macromolecules. Combining intelligently implemented technologies with in-depth industry applications knowledge and support, Malvern provides customers with the competitive advantage they demand. Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com For press information, please contact: Trish Appleton, Kapler Communications Phoenix House, Phoenix Park, Eaton Socon, Cambridgeshire, PE19 8EP, UK Tel: +44 (0)1480 471059 Fax: +44 (0)1480 471069 trish.appleton@kapleronline.com USA contact: Marisa Fraser, Malvern Instruments Inc. 117 Flanders Road, Westborough, MA 01581-1042 USA Tel: +1 508 768 6400 Fax: +1 508 768 6403 marisa.fraser@malvern.com Please send sales enquiries to: Alison Vines, Malvern Instruments Ltd Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ UK Tel: +44 (0) 1684 892456; Fax: +44 (0) 1684 892789 salesinfo@malvern.com NEXT ARTICLE More From BioPortfolio on "Malvern foundations in rheology web seminars now available in eight languages" Related Companies Related Clinical Trials Related PubMed Entries Related Medications

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