Researchers Rely on Evolving Technology to aid in the Fight Against Disease

NEW YORK, June 13, 2019 /PRNewswire/ — In 2016, a total of 56.9 million deaths were reported and of that number, 54% were due to the top 10 medical conditions. However, the two most common conditions were Ischaemic heart disease and stroke, which accounted for 15.2 million deaths in 2016 alone. Moreover, these two conditions have been the leading causes of global death in the past 15 years. Furthermore, other medical conditions such as chronic obstructive pulmonary disease, lower respiratory infections, Alzheimer’s, and lung cancers also accounted for millions of deaths collectively, according to the World Health Organization (WHO). The alarming number has prompted biotechnology and healthcare companies to develop new technology and medicine in order to help reduce the mortality rate. For instance, cancer deaths in the U.S. have declined by 27% in the past 25 years due to advancements in detection technology and treatment. Moreover, environmental changes have also played a large role in the decline of deaths. However, the majority of deaths in 2016 occurred in low-income countries where many people lack access to proper and adequate healthcare. While, predominantly, non-communicable diseases accounted for 71% of global deaths, ranging from 37% in low-income countries to 88% in high-income countries. And all but one of the 10 leading causes of deaths in high-income countries were non-communicable diseases. In terms of the absolute number of deaths, however, 78% of total non-communicable diseases occurred in low-and-middle-income countries, according to the WHO. Overall, the mortality rates are continuing to decline for certain medical ailments as companies continue to develop more effective treatments. And as a result, spending within the marketplace is increasing due to various investments as well as growing consumer spending. According to data compiled by Global Market Insights, the global biotechnology market is expected to surpass a value of USD 775 Billion by 2024. Additionally, the data forecasts the market to accelerate at a CAGR of 9.9%. Pressure BioSciences, Inc. (OTC: PBIO), AbbVie Inc. (NYSE: ABBV), Gilead Sciences, Inc. (NASDAQ: GILD), Bristol-Myers Squibb Company (NYSE: BMY), Pfizer Inc. (NYSE: PFE) 

Cancer is one of the large markets that many biotechnology companies predominantly target. In 2018, there were an estimated 1.73 million new cancer cases diagnosed and among the new group of diagnoses, 609,640 deaths are expected to occur, according to the American Cancer Society. Overall, the most common types of cancer diagnosed in men are prostate, lung, and colorectal while women are most commonly diagnosed with breast, lung, and colorectal cancer. And the decline in cancer mortality is largely due to steady reductions in smoking rates and advances in early detection and treatment. However, the American Cancer Society did note that not all populations are benefitting from the advancements. According to the most recent decade of available data from 2006 to 2015, the rate of new cancer cases fell by 2% per year in men and stayed the same for women. The cancer death rate from 2007 to 2014 had also declined by 1.4% per year in women and 1.8% per year in men. “This report also highlights our long-standing concerns about the underrepresentation of individuals from lower socioeconomic populations in cancer clinical trials and the access to treatment advances these trials may provide,” said Monica M. Bertagnolli, MD, FACS, FASCO, the President of the American Society of Clinical Oncology. “We must work to ensure every patient has access to cancer care that reflects their individual needs as well as the opportunity to participate in research and contribute to progress.”

Pressure BioSciences, Inc. (OTCQB: PBIO) yesterday announced that, “the Company’s patented pressure cycling technology (“PCT”) platform was prominently featured in 15 independent presentations at the annual conference of the American Society for Mass Spectrometry (“ASMS”), held from June 1-6, 2019 in Atlanta, GA. The presentations spanned wide ranging applications for PBI’s unique PCT platform in scientific studies, particularly their essential use in advancing knowledge and understanding in such areas as cancer research, protein function, molecular biology, and biomarker discovery.

Roxana McCloskey, PBI’s Global Director of Sales & Marketing, commented: “The number of PCT-related presentations at the 2019 ASMS conference significantly exceeded prior PBI records for a scientific meeting. We are gratified that the use of our PCT platform continues to expand to new investigators and laboratories worldwide, and that its use has shown great promise in critical areas of human health, such as cancer. We believe the presentations at this prestigious annual meeting clearly show the increasing potential for the PCT platform in diagnostics and discovery, which we believe could eventually lead to the routine use of the PCT platform in precision medicine, a rapidly expanding market that is expected to reach $217 billion by 2028 (BIS Research, 2019).”

PCT-related presentations delivered at the 2019 ASMS meeting were primarily in the following key areas.

Cancer Research: Nine presentations focused on the importance of PBI’s PCT platform in the study of cancers.Of these, three described the development and use of a novel, streamlined, sample preparation protocol and system featuring PBI’s Barocycler 2320EXT instrument and proprietary MicroTubes as the link between two widely used techniques: laser microdissection and mass spectrometry. In this new suggested system, precise small sections of cells are cut from suspected tumor tissue slices while being viewed under a microscope. Once cut from the biopsy tissue, the slices of interest fall directly into PBI’s MicroTubes, are processed by PCT and are then analyzed by mass spectrometry. Data show that the PCT platform has the potential to accelerate and strengthen protein analysis, improve cancer characterization, and provide clinically relevant information for diagnosis and treatment guidance in a timely manner. Findings also highlighted the necessity for the development of new methods and equipment for better identification of gynecologic cancers specifically, and cancer biomarkers in general.

Researchers from China and Australia reported on advancements in their cancer diagnostic programs. These large studies of thousands of cancer samples rely critically on PBI’s PCT platform to rapidly and reproducibly extract proteins from tumor tissues for analysis by mass spectrometry.

The PCT platform was also used in studies to better understand underlying racial disparities in cancer. Such studies may provide improved early detection and thus more effective treatment options to minorities.

Biomarker Discovery: Several presentations reported results from studies that used the PCT platform for basic research and discovery of unique cancer biomarkers. Discovery of new biomarkers for early diagnosis, cancer subtyping, progression, and underlying pathway dysfunction is vital to help improve clinical outcomes. In addition to cancer biomarker discovery, a presentation reported the use of the PCT platform to help reveal unique biomarkers due to exposure to chemicals in the environment such as benzene. This is the second report of using PBI technology to monitor the effects of environmental pollutants.

Protein and Molecular Biology Studies: The PCT platform continues to be used for basic but important proteomic research. The proteome consists of all the proteins made or modified by an organism. Studies presented of proteins, using PBI’s high pressure PCT system, included the use of pressure to accelerate enzymatic reactions for molecular biology and other applications, and for muscle tissue studies.

Richard T. Schumacher, President and CEO of PBI, said: “We are thrilled with both the number and caliber of presentations made at the annual ASMS conference highlighting the advantages of the PCT platform. Well-known research groups from both academia and industry, including key opinion leaders in proteomics and cancer diagnostics, presented data at the conference strongly supporting the use of the PCT platform in multiple areas of scientific research. These researchers were from highly respected labs and institutions worldwide, including: Johns Hopkins University, Fred Hutchinson Cancer Center, John P. Murtha Cancer Center, the Inova Schar Cancer Institute, Westlake University (China), Children’s Medical Research Institute (Sydney, AU), the ETH Zurich, PPD Madison, Pfizer, and SCIEX.”

Dr. Bradford Young, Sr. VP and Chief CommercialOfficer of PBI, said: “By 2025, the combined projected market sizes forcancer research, biomarker discovery, proteomics, and molecular biology isexpected to be in excess of $200 billion.The global proteomics market alone is projected to be in excess of $40 billionby 2025 (Zion Market Research, 2019). We believe the unique value provided by our PCT platform for samplepreparation and biomarker discovery as shown in the 15 presentations at this year’s ASMSConference will help generate awareness and demand for our platforms in these very largeand growing markets.”

About Pressure BioSciences, Inc: Pressure BioSciences, Inc. (OTCQB: PBIO) is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities have emerged in the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired, patented technology from BaroFold, Inc. (the “BaroFold” technology) to allow entry into the bio-pharma contract services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (“UST”) platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.”

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AbbVie Inc. (NYSE: ABBV) is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. AbbVie recently presented data from the CLL14 trial, the first randomized clinical trial to examine stopping an oral-based, chemotherapy-free combination after 12 months in previously untreated patients with CLL and coexisting medical conditions. The results demonstrate that venetoclax plus obinutuzumab prolonged progression-free survival (PFS) and achieved higher rates of complete response and minimal residual disease (MRD)-negativity compared to a commonly used standard of care obinutuzumab plus chlorambucil. “Conducting CLL14 was another collaborative and bold attempt to continue pushing the boundaries of treatment in CLL,” said Mohamed Zaki, M.D., Ph.D., Vice President, Global Head of Hematology Development, AbbVie. “The combination of venetoclax plus obinutuzumab significantly prolonged progression-free survival and patients maintained that benefit after stopping treatment. After the recent approval in the U.S., we look forward to continue working with health authorities worldwide as we aim to bring venetoclax plus obinutuzumab to patients with previously untreated CLL.”

Gilead Sciences, Inc. (NASDAQ: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Kite, a Gilead Company, recently announced findings from two new analyses from the ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma. These results include a two-year sub-population analysis of efficacy and safety in ZUMA-1 patients (registrational Cohorts 1 and 2) by age, as well as preliminary data from a separate safety management study of patients receiving early steroid intervention for cytokine release syndrome (CRS) and neurologic events. The results were presented today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting May 31st – June 4th, in Chicago. “Longer-term data from ZUMA-1 have shown more than half of patients were still alive two years after treatment with Yescarta,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We are committed to further defining the clinical profile of Yescarta, including evaluation of new safety management protocols to further enhance patient care and help move the cell therapy field forward.”

Bristol-Myers Squibb Company (NYSE: BMY) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Company recently announced updated results from studies evaluating Opdivo (nivolumab) and Yervoy (ipilimumab), alone or in combination, in patients with advanced or metastatic melanoma. These analyses (Abstracts #9533, #9568 and #9551) were featured on Monday, June 3 at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago. An analysis exploring long-term quality of life (QoL) and symptom burden in the Phase 3 CheckMate -067 study found that QoL was maintained during the treatment-free interval (TFI) – the period where a patient is off study treatment and free of subsequent therapy – in patients with previously untreated unresectable or metastatic melanoma following discontinuation of therapy with Opdivo or Opdivoplus Yervoy. Patient reported outcome (PRO) scores were maintained from last on-treatment visit to follow-up 1 (30 days after the last dose) or follow-up 2 (84 days after follow-up 1) for patients who discontinued treatment. PRO scores remained stable beyond follow-up 2 for the EQ-5D-3L (measures of mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which were collected at survival follow-up visits every three months in the first year and then every six months. “These latest results provide further support for the long-term scientific rationale for combining Opdivo and Yervoy for the treatment of advanced melanoma,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We will continue to evaluate the combination in these patients, as it also provides us with a wealth of valuable scientific information on the impact of immuno-oncology therapy in this population.”

Pfizer Inc. (NYSE: PFE) applies science and our global resources to bring therapies to people that extend and significantly improve their lives. Pfizer Inc. recently announced positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ^® (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with XELJANZ XR 11 mg QD compared to XELJANZ XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score (DAS28-4[ESR]) from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. The study results will be presented during a late-breaking oral session at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (15 June). “The results of ORAL Shift provide important information on the use of XELJANZ XR as monotherapy after methotrexate withdrawal, which is significant as some people living with rheumatoid arthritis are unable or unwilling to use methotrexate,” said Stanley Cohen, MD, Metroplex Clinical Research Center, Dallas, TX. “From a clinical perspective, these results give physicians data to help inform the decision to take appropriate patients off methotrexate.”

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