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Advances in Biotechnology May Offer Cancer Patients Renewed Hope

NEW YORK, Sept. 10, 2019 /PRNewswire/ -- The biotechnology market is currently one of the largest industries in the world. Biotechnology is defined as technology that is used to modify or upgrade the biological system, in order to improve human welfare. However, despite being the largest sector globally, there are still various segments that haven't been fully tapped into, presenting opportunities for a plethora of companies. In more technologically advanced nations, researchers have developed techniques and procedures that can completely cure or slow down the spread of specific ailments such as cancer or HIV. Notably, processes within the industry include microbiology, genetic engineering, biochemistry, among many others. And while there are many various types of medical conditions, the market is seeing a large spur of demand for therapeutic and diagnostic solutions such as red biotechnology, recombinant technology, and DNA sequencing. Overall, the presence of a multitude of companies focusing on regenerative therapies is expected to drive the biotechnology industry further forward. Moreover, some companies are also integrating advanced tech such as artificial intelligence and machine learning to more effectively combat individual medical cases. Furthermore, medical institutions are continually releasing new data to help improve the efficiency of medical technology. According to data compiled by Grand View Research, the global biotechnology market is expected to reach USD 727.1 Billion by 2025 while exhibiting a CAGR of 7.4%. Pressure BioSciences, Inc. (OTC: PBIO), Abbott Laboratories (NYSE: ABT), Gilead Sciences, Inc. (NASDAQ: GILD), AbbVie Inc. (NYSE: ABBV), Bristol-Myers Squibb Company (NYSE: BMY)

The cancer treatment market is one of the biggest segments of the biotechnology industry. According to the National Cancer Institute, it was estimated that 1.73 million in the U.S. were affected by cancer in 2018. Additionally, the report also suggested that 609,640 people passed away due to cancer. Overall, cancer research has accelerated over the past several decades. And typically, most cancer patients undergo various types of therapies such as chemotherapy or radiotherapy. Generally, these therapies use stimulants such as anti-cancer drugs or radiation to eradicate cancerous cells. However, the acceleration of the cancer technology market has introduced new procedures such as personalized treatments. Notably, formalin-fixed paraffin-embedded (FFPE) has become a crucial part of cancer research in labs nowadays. FFPE is a form of preservation and preparation for biopsy specimens that aid in the examination, experimental research, and diagnostic/drug development, according to Biochain. A tissue sample is first preserved by fixing it in formaldehyde to preserve the proteins and vital structures within the tissue. The tissues are frequently used in immunohistochemistry (IHC). The information provided from IHC can aid doctors in looking for signs of diseases such as cancer or Alzheimer's disease. As the cancer treatment industry continues to advance, medical researchers are continuing to develop treatments and therapies that will effectively eliminate or limit the condition in patients. And with the number of cases emerging around the world, the biotechnology market is primed to witnessed substantial growth. "I see major advances in saving lives from cancer in the next 10 years by eliminating cancer health disparities. By implementing our research findings and changing how we organize the care to patients, we can reduce and eliminate cancer health disparities," according to Karen M. Freund, M.D., M.P.H., Tufts Medical. " We have shown through research that providing additional support to vulnerable patients and to their physicians, to provide education, support, and address the unique barriers they face, we can provide all patients the best care and best hope for a cure."

Pressure BioSciences, Inc. (OTCQB: PBIO) announced breaking news this morning that, "today the publication of two scientific journal articles, led by independent teams of scientists in China and Australia, reporting excellent results with PBI's Pressure Cycling Technology ("PCT") platform in processing preserved formalin-fixed paraffin-embedded ("FFPE") and fresh frozen biopsy tissue samples for discovery and elucidation of cancer biomarkers and potentially for use in clinical diagnostics based upon these markers. The Chinese team from Westlake University (Hangzhou, China) purchased their first two PCT platforms in 2017 and subsequently purchased four additional PCT systems. The Australian Proteome of Human Cancer ("ProCan") team bought their first PCT system in 2016 and have subsequently added five more PCT platforms.

FFPE preserved tissue samples are an invaluable resource for retrospective studies of disease progression and response to therapy, because the disease outcome associated with the tissue and patient's treatment history are known. Effective studies on these sample sets can accelerate discoveries of new therapies, drugs, and preventive strategies. FFPE has been long-established as the most common technique worldwide for the preservation of tissues for later study. Archival repositories exist that contain a total of millions to a billion or more FFPE tissue samples. However, the analysis of FFPE samples has historically been problematic. FFPE preservation techniques were designed for permanence and stability – hence it is challenging to reverse this fixation and to liberate and extract the important biomolecules relevant as cancer biomarkers. Significantly, both publications cited here, together with other publications (See PBI Website), now report excellent results using the PCT sample preparation platform for comprehensive and reliable extraction and presentation of important proteins for analysis, from both FFPE and fresh frozen tissue samples.

Mr. Richard T. Schumacher, President and CEO of Pressure BioSciences, commented: "It is estimated (Nature volume 448, pages 959–962, 23 August 2007) that well over one billion archival FFPE tissue samples exist in pathology and other laboratories worldwide. We believe there are millions of new FFPE tissue samples processed and stored each year. These samples offer the promise of unveiling invaluable information that can lead to the development of new treatments, cures, and preventive measures for cancer and many other diseases. However, up to now, it has been very difficult to extract this information from biomolecules in FFPE samples."

Ms. Roxana McCloskey, Director of Marketing and Sales at PBI, said: "We believe that our PCT platform is establishing itself as the method of choice for the superior extraction of potential biomarkers and their presentation for the effective proteomic analyses that will propel the growth of this huge market. We expect this exciting, now proven application of our PCT Platform for protein biomarker discovery in fresh frozen and FFPE biopsy samples to manifest itself in increased sales as soon as the second half of 2019."

The global cancer biomarkers market alone is expected to exceed more than US $157 Billion by 2022 (MarketWatch January 8, 2019).

In their publication High-throughput proteomic analysis of FFPE tissue samples facilitates tumor stratification, Professor Tiannan Guo, Laboratory Director at Westlake University, explained: "We developed the PCT-SWATH/DIA method of coupling pressure cycling technology for sample preparation with a high throughput mass spectrometry workflow, to analyze FFPE tissue proteomes. We showed that our workflow is a robust and reproducible proteomic method to analyze FFPE tissues from both bulk tissue and tiny biopsy samples as well as sectioned tissue slices."

Dr. Guo continued, "We believe that the vast reservoirs of historical FFPE tissue samples accumulated in biobanks worldwide offer enormous potential using our methods for biomarker discovery, by leveraging the practicality and superiority of PBI's PCT sample preparation platform for maximizing the diversity and abundance of results from FFPE samples (over even fresh frozen samples), followed by mass spectrometry analysis in the PCT-SWATH/DIA workflow."

Professor Phil Robinson, Co-Director of ProCan, stated: "The key to clinical application of tissue-based proteomics is to adapt to the practical requirements of clinical workflow. Our results from FFPE tissues following PCT sample preparation are consistent with other reports showing that high quality data can be generated and that the scale and scope of quantifiable proteins is comparable to that obtained from fresh frozen tissues."

Professor Robinson continued: "After samples are collected, tissue lysis and digestion protocols must be rapid, efficient, reproducible and broadly applicable to tissues of different kinds and from different source laboratories. In addition, the methodology should be adaptable for integration of robotics to facilitate high throughput where possible. ProCan has instituted the use of pressure cycling technology (PBI Barocyclers) to achieve consistent and superior lysis and digestion of tissue samples." (Addressing the challenges of high-throughput cancer tissue proteomics for clinical application: ProCan®).

About Westlake Institute for Advanced Study (now Westlake University)

Westlake Institute for Advanced Study ("WIAS") is a non-profit research institute dedicated to the advancement of natural sciences and the frontiers of engineering disciplines. Located in the beautiful Cloud Town of Xihu District, Hangzhou, China, WIAS strives to represent the scientific strength of China, to influence the nation's future, and to promote inclusive development and progress. WIAS, now grown into Westlake University, aims at establishing a top-level research-oriented global university. At WIAS, scientific knowledge and technological advancement are utilized to have a real-life impact on the world and to benefit human beings. Leading talent with innovative spirit and capabilities are trained to become the driving force of China's development.

About ProCan

The Australian Cancer Research Center Foundation International Centre for the Proteome of Cancer ("ProCan") is located in newly renovated laboratory facilities at the Children's Medical Research Center ("CMRI") near Sydney, Australia. The goal of ProCan is to analyze over 70,000 cancer samples from all over the world over the next 5 years, with over 10,000 samples completed to date. This will enable a better understanding of cancer, as well as provide a means of personalized precision diagnosis and treatment, giving clinicians the information needed to decide on the best option for each individual patient. CMRI is an official collaborator of the US National Cancer Institute's Cancer Moonshot initiative, with a key objective to accelerate what would normally take ten years of cancer research to completion in five years.

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., CBD Oil 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.

Abbott Laboratories (NYSE: ABT) is a global healthcare leader that helps people live more fully at all stages of life. Abbott recently announced the company had received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease. The MitraClip device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood (known as mitral regurgitation, or MR), restoring the heart's ability to pump oxygenated blood more efficiently. To date, MitraClip has helped treat more than 80,000 people worldwide suffering from both primary and secondary MR and is supported by the industry's most extensive body of clinical evidence, including the recent results of the landmark COAPT™ Trial published in The New England Journal of Medicine in September 2018. "We are continually innovating the MitraClip technology based on the experience of the physicians implanting the device so we can truly help them improve the lives of their patients," said Neil Moat, M.D., Chief Medical Officer of Abbott's structural heart business. "With the fourth generation of MitraClip, we set out to build a system that would help physicians individualize the therapy to each patient and deliver even more features that can treat both primary and secondary mitral regurgitation."

Gilead Sciences, Inc. (NASDAQ: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead Sciences, Inc. Galapagos NV recently announced the closing of the global research and development collaboration agreement signed on July 14th, 2019. Galapagos discovers and develops small molecule medicines with novel modes of action, three of which show promising patient results and are currently in late-stage development in multiple diseases. "We are excited to close this unique agreement, which will generate both long-term strategic value and mutual, immediate benefits," said Daniel O'Day, Chairman and Chief Executive Officer of Gilead. "The collaboration reflects Gilead's intent to grow our innovation network through diverse and creative partnerships."

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 announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline. An Independent Data Monitoring Committee (IDMC) recommended terminating MERU due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at a pre-planned interim analysis. Results from the MERU trial will be presented at a future medical meeting and/or published in a peer-reviewed medical journal. "Small-cell lung cancer continues to be one of the most difficult-to-treat cancers where there is a significant need for transformative therapies. We are disappointed with this outcome for the patients who suffer from this disease," said Margaret Foley, M.D., Vice President, Global Head of solid tumor development, AbbVie. "We remain committed to researching and developing other therapies with the potential to transform care for patients with small-cell lung cancer and other malignancies."

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 that the Phase 3 CheckMate -548 trial evaluating the addition of Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone did not meet one of its primary endpoints, progression-free survival (PFS), in patients with newly diagnosed glioblastoma multiforme (GBM) that is O6-methylguanine-DNA methyltransferase (MGMT)-methylated. The data monitoring committee recommended that the trial continue as planned to allow the other primary endpoint, overall survival (OS), to mature. The company remains blinded to all study data. "Though CheckMate -548 did not show statistically significant improvement in progression-free survival, we are continuing to evaluate the benefit the addition of Opdivo to the standard of care treatment regimen may bring to patients suffering from GBM, an extremely aggressive and difficult disease to treat. We look forward to seeing the overall survival data when they are available," said Fouad Namouni, M.D., Head, Oncology Development, Bristol-Myers Squibb. "We are grateful to the patients, caregivers and investigators participating in this trial who make this research possible."

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