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Photomicrograph of human nerve cell.

April, 2017
Trade Article written by David Holley at Xconomy.

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January, 2017
PBI is extremely pleased to announce an expansion of their Scientific Advisory Board to include world class experts in antiviral, neurodegenerative disease and cancer related research fields. Please see the SAB tab on this web page to view current SAB members, institutional affiliations and brief biographies.

January, 2017
Because the active principle ingredient in PBI-05204 readily crosses the blood brain barrier (BBB) it has the potential to benefit malignant disease that resides in the brain. PBI has initiated research on pediatric glioblastoma multiforma (GBM) together with Dr. Xiao-Nan Li (Brain Tumor Program, Texas Children’s Cancer Center, Baylor College of Medicine) and Dr. Peiying Yang (Univ. Texas M. D. Anderson Cancer Center). Initial preclinical research with PBI-05204 against human GBM growing in vitro as well as in murine brain tissue has been very encouraging. There are few, if any, current effective drugs available for treatment of pediatric GBM.

December, 2016
PBI is in the process of concluding its Phase II trial of PBI-05204 against advanced, drug refractory pancreatic cancer. This disease is often diagnosed only after it has metastasized throughout the body making any truly effective treatment difficult. PBI-05204 was evaluated in this patient population at five clinical sites across the USA. In addition to once again demonstrating the safety of our drug, we are pleased to announce that a partial response and several stable disease designations were obtained.

December, 2016
Due to initial success of PBI-05204 against HIV in preclinical studies PBI has expanded its antiviral research program to include new research of the effectiveness of its drug against viruses such as cytomegalovirus (CMV), respiratory syncytial virus (RSV), as well as truly deadly viruses for which there are at present no effective therapies. Initial preclinical results against all of these viruses look promising suggesting that PBI-05204 may serve as a novel broad-spectrum antiviral agent.

June, 2016
The article titled "Pharmacokinetics and Comparative Effects of Frondosides in Pancreatic Cancer" by: Jasem Al Shemaili, Khatija Parekh, Robert Newman, Björn Hellman, Carl Woodward, Abdu Adem, Peter Collin, Thomas E Adrian is now published in Marine Drugs.

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May, 2016
Publication: "Dual activities of the anti-cancer drug candidate PBI-05204 provide neuroprotection in brain slice models for neurodegenerative diseases and stroke" by Michael Van Kanegan, Denise Dunn, Linda Kaltenbach, Bijal Shah, Dong Ning He, Daniel McCoy, Peiying Yang, Jiangnan Peng, Shen Li, Lin Du, Robert Cichewicz, Robert A. Newman, and Donald Lo. Nature Scientific Reports.

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April, 2016
PBI is pleased to announce an excellent rate of accrual of advanced pancreatic cancer patients to their Phase II clinical study. To date, 37 patients of the target goal of 50 have been entered on the study with no serious adverse events attributable to the investigational drug. Given that our drug is an oral capsule and does not cause debilitating side effects or hair loss, it is an attractive alternative to patients who would rather not have to deal with frequent trips to the hospital for intravenous injections. For these patients, maintaining quality of life is an important consideration. The goal of our PBI-05204 clinical trial is to provide evidence of efficacy and safety in this patient population. To date there is evidence of activity in this heavily pretreated patient population and we are anticipating completion of the trial by the end of the year. The trial is being conducted at five prestigious clinical institutions within the USA.

September, 2015
Research with colleagues at Duke University continues to reveal important brain mediated benefits in response to PBI-05204. Not only have our two published studies shown an increase in brain derived neurotrophic factor (BDNF) but research now being prepared for publication shows a significant response of ARE (antioxidant response elements) in brain tissue which is associated with protection of neurons from oxidative injury.

August, 2015
NIH has expressed an interest in exploring the potential of PBI-05204 to alleviate the extreme fatigue often associated in cancer patients undergoing radiation therapy. The reasoning behind this is that brain derived neurotrophic factor (BDNF) levels have been observed to fall in these patients. Given that PBI’s drug increases BDNF levels in brain tissue, it is hypothesized that this may be of benefit and increase the quality of life in cancer patients who receive radiation therapy. Phoenix Biotechnology is delighted that NIH has recognized the value of our drug for this purpose and will work closely with them in these ongoing studies.

July, 2015
We are pleased to announce that by the end of this month there will be 5 clinical sites open across the USA that are approved to enroll patients to our Phase II trial for treatment of advanced pancreatic cancer. These sites include Vanderbilt University Medical Center (Nashville, TN), Virginia Mason Medical Center (Seattle, WA), Virginia Cancer Specialists (Fairfax, VA), Florida Hospital Tampa (Tampa, FL) and HonorHealth (Scottsdale, AZ). Further information on the trial and criteria for enrollment eligibility can be obtained at www.clinicaltrials.gov and searching under "PBI-05204".

January, 2015
In late December, 2014 the FDA approved of our plans to take PBI-05204 forward into clinical Phase II trials. The clinical study titled "A Phase II, Single-arm, Open-Label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients with Stage IV Metastatic Pancreatic Adenocarcinoma" will be conducted at multiple sites within the USA including such prestigious institutions as Vanderbilt University Medical Center. It is anticipated that the first patient will be enrolled this summer.

November, 2014
A manuscript describing the therapeutic effects of PBI-05204 against human pancreatic cancer implanted orthotopically (within the pancreas) in immunocompromised mice has been accepted for publication in Investigational New Drugs. The article shows that the botanical drug PBI-05204 is effective in a dose dependent manner and superior to the standard-of-care approved drug known as gemcitabine. The title and authors are: PBI-05204, a supercritical CO2 extract of Nerium oleander, inhibits growth of human pancreatic cancer via targeting the PI3K/mTOR pathway. Pan Y., Rhea, P.,Tan L, Lee H. J., Ravoori M., Addington C.,Gagea M., Kundra V, Kim S-J, Newman R.A., and Yang P. Read Article

June, 2014
A manuscript describing the results of the Phase I trial of PBI-05204 conducted at the Univ. Texas M. D. Anderson Cancer Center has been published in Investigational New Drugs. The title and authors are: First-In-Human Study of PBI-05204, an Oleander-Derived Inhibitor of Akt, FGF-2, NF-kB and p70S6K, In Patients with Advanced Solid Tumors. D.S. Hong, H. Henary, G.S. Falchook, A. Naing, S. Fu, S. Moulder, J.J. Wheler, A. Tsimberidou, J.B. Durand, R. Khan, M. Johansen, P. Yang, R.A. Newman and R. Kurzrock. Investigational New Drugs, June, 2014. PMID: 24919855

May, 2014
Additional testing of PBI-05204 against patient derived tumors is being conducted at Rational Therapeutics (San Diego, CA). The purpose of the research is to determine relative activity of PBI's lead drug against pancreatic cancer for which very few active drugs exist. In addition, the relative activity of PBI-05204 in combination with standard of care cancer chemotherapeutic agents is also being examined. Initial results are encouraging.

January 2014
Publication: BDNF Mediates Neuroprotection against Oxygen-Glucose Deprivation by the Cardiac Glycoside Oleandrin. Michael J. Van Kanegan, Dong Ning He, Denise E. Dunn, Peiying Yang, Robert A. Newman, Anne E. West and Donald C. Lo. The Journal of Neuroscience, 15 January 2014, 34(3): 963-968; doi: 10.1523/JNEUROSCI.2700-13.2014.

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January 2014
Presentation Abstract: PBI-05204, a supercritical CO2 extract of Nerium oleander, inhibits the growth of human pancreatic cancer in a Panc-1 orthotopic model by down-regulation of PI3k/mTOR pathways. Dr. Robert A. Newman, our Chief Science Officer will be presenting at the Beaujon Conference in Paris, France, on February 13-15.

April 2013
Presentation Abstract: PBI-05204, a supercritical CO2 extract of Nerium oleander, inhibits the growth of human pancreatic cancer in a Panc-1 orthotopic model by down-regulation of PI3k/mTOR pathways. Yong Pan, Sun-Jin Kim, Patrea Rhea, Carrie Cartwright, Ho Jeong Lee, Crandell Addington, Mihai Gagea, Robert A. Newman, Peiying Yang. UT MD Anderson Cancer Ctr., Houston, TX. AACR Annual Meeting 2013.

Abstract

POSTER (When open please zoom-in to see the details)

Ex-Vivo Programmed Cell Death in Human Tumor Samples Produced by Exposure to PBI-05204 - Results

November 2012
Publication: Nerium oleander derived cardiac glycoside oleandrin is a novel inhibitor of HIV infectivity. Singh S, Shenoy S, Nehete PN, Yang P, Nehete B, Fontenot D, Yang G, Newman RA, Sastry KJ. Fitoterapia, November 2012. PMID: 23127567

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October 2012
Publication: Cellular location and expression of Na+, K+-ATPase α subunits affect the anti-proliferative activity of oleandrin. Yang, P., Cartwright, C., Efuet, E., Hamilton, S. R., Wistuba, I. I., Menter, D., Addington, C., Shureqi, I. and Newman, R. A. (2012). Mol. Carcinog. doi: 10.1002/mc.21968. PMID: 23073998

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Publication: Digoxin and ouabain induce the efflux of cholesterol via liver X receptor signalling and the synthesis of ATP in cardiomyocytes. Campia I, Sala V, Kopecka J, Leo C, Mitro N, Costamagna C, Caruso D, Pescarmona G, Crepaldi T, Ghigo D, Bosia A, Riganti C. Biochem. J. (2012) 447, 301–311 (Printed in Great Britain) doi:10.1042/BJ20120200. PMID: 22845468

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Data: Evidence of downregulation of cholesterol and triglyceride with administration of an extract of Nerium Oleander. File

July 2012
Research Article: Cardiac glycosides exert anticancer effects by inducing immunogenic cell death. Menger L, Vacchelli E, Adjemian S, Martins I, Ma Y, Shen S, Yamazaki T, Sukkurwala AQ, Michaud M, Mignot G, Schlemmer F, Sulpice E, Locher C, Gidrol X, Ghiringhelli F, Modjtahedi N, Galluzzi L, André F, Zitvogel L, Kepp O, Kroemer G. Source INSERM, U848, F-94805 Villejuif, France. PMID: 22814852

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January 2012

Phoenix Biotechnology executes a seventh amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center.

December 2011
Phoenix Biotechnology enters into a research agreement with Rational Therapeutics, Inc. to conduct examination of antitumor effects of PBI-05204 on human tumor biopsy samples (an 'in vitro' Phase II study).

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November 2011
Publication: In vitro and in vivo neuroprotective activity of the cardiac glycoside oleandrin from Nerium oleander in brain slice-based stroke models. Dunn DE, He DN, Yang P, Johansen M, Newman RA, Lo DC. J Neurochem. 2011 Nov;119(4):805-14. PMID: 21950737

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August 2011
Phoenix executes a Sponsored Research Agreement with Duke University for in vivo research in animal models to study prevention of ischemic stroke using PBI-05204.

June 2011
ASCO annual meeting poster presentation along with an oral format with discussion of clinical trial results of PBI-05204.

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June 2011
Phoenix Biotechnology executes a sixth amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center.

May 2011
Phase I Clinical Trial of PBI-05204 successfully completed at M. D. Anderson Cancer Center.

July 2010
Phoenix raises >$3,000,000 from angel investors.

September 2010
Phoenix Biotechnology executes a fifth amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center.

June 2010
Publication: Human tumor cell sensitivity to oleandrin is dependent on relative expression of Na+, K+ -ATPase subunits. Lin Y, Ho DH, Newman RA. J Exp Ther Oncol. 2010;8(4):271-86. PMID: 21222360

April 2010
Phoenix Biotechnology executes a fourth amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center.

November 2009
Society of Integrative Oncology (SIO) International Conference- comprehensive poster presentation with discussion.

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August 2009
Phoenix Biotechnology executes a third amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center.

Publication: Oleandrin-mediated inhibition of human tumor cell proliferation: importance of Na,K-ATPase alpha subunits as drug targets. Yang P, Menter DG, Cartwright C, Chan D, Dixon S, Suraokar M, Mendoza G, Llansa N, Newman RA. Mol Cancer Ther. 2009 Aug;8(8):2319-28. PMID: 19671733

May 2009
Update on Phase I trial of PBI-05204: ASCO annual meeting poster presentation with discussion.

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February 2009
Phoenix Biotechnology executes a Sponsored Research Agreement with Duke University for in vitro research in neurological disorders using PBI-05204 and certain discrete fractions of the whole extract.

September 2008
Phoenix Biotechnology executes a second amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center.

Publication: Determinants of human and mouse melanoma cell sensitivities to oleandrin. Lin Y, Dubinsky WP, Ho DH, Felix E, Newman RA. J Exp Ther Oncol. 2008;7(3):195-205. PMID: 19066128

July 2008
Phoenix raises >$3,000,000 from angel investors.

February 2008
Publication: Cardiac glycosides as novel cancer therapeutic agents. Newman RA, Yang P, Pawlus AD, Block KI. Mol Interv. 2008 Feb;8(1):36-49. Review. PMID: 18332483

December, 2007
Publication: Autophagic cell death of human pancreatic tumor cells mediated by oleandrin, a lipid-soluble cardiac glycoside. Newman RA, Kondo Y, Yokoyama T, Dixon S, Cartwright C, Chan D, Johansen M, Yang P. Integr. Cancer Ther. 2007 Dec;6(4):354-64. PMID: 18048883

October 2007
Phoenix executes an amendment to its Sponsored Research Agreement with M. D. Anderson Cancer Center

August 2007
USFDA approves Phoenix IND 73,624 application to conduct a Phase I Trial with PBI-05204, a patented supercritical extract of Nerium oleander, in patients with advanced cancer.

June 2007
Phoenix enters into contract with Quintiles, Inc. to act as Clinical Research Organization for "An Open Label Phase I Trial of PBI-05204 in Advanced Cancer Patients" to be conducted at M. D. Anderson Cancer Center.

December 2006
Phoenix Biotechnology, Inc. executes a share exchange agreement with Nerium Biotechnology, Inc. by which Nerium Biotechnology acquires all the Latin American operations of Phoenix.

July 2006
Publication: Oleandrin-mediated oxidative stress in human melanoma cells. Newman RA, Yang P, Hittelman WN, Lu T, Ho DH, Ni D, Chan D, Vijjeswarapu M, Cartwright C, Dixon S, Felix E, Addington C. J Exp Ther Oncol. 2006;5(3):167-81. PMID: 16528968

June 2005
Focus on Health: Oleander plant shows promise as cancer-fighter.
Wednesday, June 22, 2005
By Dr. Karen Johnson / KHOU 11 News - Houston

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April 2005
Phoenix raises >$5,000,000 from angel investors

October 2004
Phoenix executes a Sponsored Research Agreement with Univ. Texas M. D. Anderson Cancer Center for research into the pharmacology and anticancer effects of Nerium oleander.

2004
Phoenix Biotechnology is designated a "Super Star" by the San Antonio Technology Accelerator Initiative.

August 2003
Phoenix Biotechnology acquires the assets of Anvirlat, Inc., a Nevada corporation, conducting pharmaceutical research in Central America on the therapeutic effects of plant extracts for patients suffering from neoplastic disease.

April 2003
Phoenix Biotechnology raises >$1,000,000 from angel investors

March 2003
Phoenix Biotechnology, Inc. is formed as a Texas corporation

2000 - 2002
Initial publications of pharmacology studies of Nerium oleander conducted at Univ. Texas M. D. Anderson Cancer Center include:

LC/MS/MS analyses of an oleander extract for cancer treatment. Wang X, Plomley JB, Newman RA, Cisneros A. Anal Chem. 2000 Aug 1;72(15):3547-52. PMID: 10952541

Oleandrin suppresses activation of nuclear transcription factor-kappaB, activator protein-1, and c-Jun NH2-terminal kinase. Manna SK, Sah NK, Newman RA, Cisneros A, Aggarwal BB. Cancer Res. 2000 Jul 15;60(14):3838-47. PMID: 10919658

Cardiac glycosides stimulate Ca2+ increases and apoptosis in androgen-independent, metastatic human prostate adenocarcinoma cells. McConkey DJ, Lin Y, Nutt LK, Ozel HZ, Newman RA. Cancer Res. 2000 Jul 15;60(14):3807-12. PMID: 10919654

Anvirzel, an extract of Nerium oleander, induces cell death in human but not murine cancer cells. Pathak S, Multani AS, Narayan S, Kumar V, Newman RA. Anticancer Drugs. 2000  Jul;11(6):455-63. PMID: 11001386

Inhibition of export of fibroblast growth factor-2 (FGF-2) from the prostate cancer cell lines PC3 and DU145 by Anvirzel and its cardiac glycoside component, oleandrin. Smith JA, Madden T, Vijjeswarapu M, Newman RA. Biochem Pharmacol. 2001 Aug 15;62(4):469-72. PMID: 11448457

Composition and preliminary pharmacology studies with Anvirzel: An extract of Nerium oleander. Newman RA, Cisneros A, Felix E, Vijjeswarapu M, Lin Y, Yang P, and Azadi P. J. Herbal Pharmacotherapy. 2001 1(3):1-16

Murine pharmacokinetics and metabolism of oleandrin, a cytotoxic component of Nerium oleander. Ni D, Madden TL, Johansen M, Felix E, Ho DH, Newman RA. J Exp Ther Oncol. 2002 Sep-Oct;2(5):278-85. PMID: 12416031