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Nosocomial Infections

Phages vs. Nosocomial Infections Phage Biotech Ltd. develops and produces bacteriophages anti-bacterials which destroy antibiotic-resistant bacterial concentrations rapidly, safely and effectively. Nosocomial Infections. Nosocomial infections result from treatment in a hospital, but are

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Nosocomial Infections

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  1. Phages vs. Nosocomial InfectionsPhage Biotech Ltd. develops and produces bacteriophages anti-bacterials which destroy antibiotic-resistant bacterial concentrations rapidly, safely and effectively

  2. Nosocomial Infections Nosocomial infections result from treatment in a hospital, but are secondary to the patient's original condition. Such hospital-acquired infections are even more alarming in the 21st. century as antibiotic resistance spreads. Reasons: • Hospitals house large numbers of people who are sick and whose immune system are often in a weakened state • Increased use of outpatient treatment means that people who are in the hospital are sicker on average • Medical staff move from patient to patient, providing a way for pathogens to spread • Many medical procedures bypass the body's natural protective barriers • Routine use of anti-microbial agents in hospitals creates selection pressure for the emergence of resistant strains

  3. Epidemiolgy • In the US and Europe, an estimated 5-10% of patients are expected to develop an infection during their hospital stay. The four main types of infections that occur within the hospital setting are urinary tract infections, hospital acquired pneumonia, surgical site infections and blood-stream infections, accounting for approximately 35%, 15%, 14% and 10% respectively. (Datamonitor) • Over 15% of which result in death • Annual costs in the US exceed $11 billion • Nosocomial infections contribute to over 100,000 deaths in the US

  4. מהעתונות: • "חיידק VREהתפרץ באיכילוב; 20 חולים הושמו בבידוד". YNET 28.01.05 • "שלושה חולים בשיבא ועוד שלושה ילדים בשניידר נדבקו בחיידק VRE העמיד בפני אנטיביוטיקה". YNET 30.01.05 • "סגירת הפגייה של הדסה הר הצופים לקבלת פגים חדשים, בגלל זיהום חמור שהתגלה אצל תשעה פגים ששהו בה בשבוע שעבר". YNET 17.4.05 • "בבית החולים הדסה, תקף בחודש האחרון חיידק מסוכן VRE לפחות 5 חולים". WALLA 3.2.06 • "לאחרונה התגלתה עלייה חדה בבידודו של חיידק VRE בבתי החולים ובבתי האבות, שפיתח עמידות נגד טיפול אנטיביוטי". NRG 7.4.06 • "חמישה פגים מהמחלקה לטיפול נמרץ ביילוד בבית החולים נהריה התגלו כנשאים של חיידק VRE עמיד לאנטיביוטיקה". NRG 23.5.06

  5. Hospital “Super Bugs” • MRSA • VRE • Pseudomonas aeruginosa • Clostridium • Klebsiela • Acinetobacter • E.coli • Proteus

  6. Market Trends • Antibiotic-resistance is accelerating and expanding • Antibiotics market is stagnating • Last ethical antibiotics expire and Pharma is dumping off its antibiotic operations • No alternative anti-bacterials in pipeline • Conventional sanitation accelerates hospital-acquired bacteria • Increase in nosocomial infections, mortality, and costs • Shift toward ecological methods in microbial control

  7. Phage Technology • Bacteriophages are ubiquitous bacterial viruses that can only attach to, replicate in, and in the process, kill specific bacteria • Phage Biotech's proprietary process enables the rapid production of high-volume, highly concentrated bacteriophage suspensions for de-contamination and treatment

  8. Head Genetic Material Tail Phage Structure Phage Biotech Ltd. – Business Plan

  9. Phage Function Bacteriophage attaches to target bacterial cell and injects the genetic material Phage replicates Bacterial cell disintegrates, and new phages released to infect other bacterial cells Phage Biotech Ltd. – Business Plan

  10. Phages thrive in the presence of bacteria, and die out in their absence Phages action is specific, and does not harm vital micro flora Phages may be used both preventively, and in the treatment of ongoing infections Phages present the only viable alternative and, potentially, the last resort for the treatment of antibiotic-resistant infections Phage-bacteria co-evolution provides for an inexhaustible reservoir of virulent phages The Phage Advantage

  11. The Product • A liquid suspension (10^8 PFU) of purified lytic bacteriophages with strain-specific or polyvalent anti-bacterial activity. • Application by surface spraying 1L/1,000 SQM. • Reduction of bacterial titer by several logs in hours.

  12. The Benefits Patients Benefits: Hospitalized patients and the community will benefit from a reduced exposure to common hospital-acquired infections. Hospitals Benefits: • Less sanitation and treatment costs • less closures, quarantines, evacuations • Less costly control and preventive measures • Less operational costs • less liability lawsuits • Less adverse publicity and an improved reputation

  13. The Market • Therapeutics: phage medicines will gradually replace ineffective antibiotics in the $150 billion anti-bacterials market. • Sanitation: phage de-contaminants are critically needed for the $70 billion hospitals sanitation market.

  14. Alternatives • Antibiotics – ineffective, banned or restricted • Vaccines - few, expensive and often impractical • Sanitation – Selective pressure favoring “Super Bugs” • Probiotics - partial preventive measures

  15. Management • Asher Wilf – Founder and CEO • Ph.D. Sergey Bujanover – Director, Chief Scientist (Microbiology, Virology) • Prof. Natalia N. Voroshilova, M.D. (Immunopreparat) – Scientific Advisor (Phage Therapy) Scientific Advisory Board • Prof. Gerald Cohen (Tel Aviv University) – Scientific Advisor (Microbiology, Phages, Drug targeting, Antibacterials) • Prof. Alik Honigman (Hebrew University) – Scientific Advisor (Microbiology Phages, Virology, Genetical engineering) • Prof. Ethan Rubinstein, M.D.(Shiba-Tel Hashomer Medical Center) – Scientific Advisor (Infectious diseases). • Prof. Zeev Handzel, M.D. (Kaplan Hospital) – Scientific Advisor (Immunology and Pediatrics). • Prof. Stephen T. Abedon (OSU) – Scientific Advisor (Microbiology, Phage Ecology) Strategic collaboration: Immunopreparat, Ufa, Russia

  16. The Core Technology Phage Biotech Ltd. has developed a proprietary cost-effective process enabling low-end, high volume applications such as feed additives, as well as an efficient pharmaceutical grade purification process (US Patent No. US/IL03/01041). Technology Features • Low cost production infrastructure and equipment • Non-fermentation, low volume, high titer process • Optimal process control • No contamination Additional IP assets: • Phages collections • Proprietary formulations • Wild phages isolation and matching algorithms

  17. Regulation • The first ever landmark FDA approval has been granted in August 2006 to a Listeria phages food additive. • An EPA approval for the same product as a surface decontaminant has been granted. • An approval for similar products targeting E.coli and Salmonella is imminent.

  18. The Model • Setting up a dedicated clinical phage lab • Isolating phages in-situ and acquisition from collections • Setting up cultures and phages libraries • Selecting virulent phages against clinical isolates • Producing purified lysates

  19. Products and services • Bacterial decontamination products and services for hospitals • Phage Medicines • Phage Therapy Treatments • Contract R&D • Contract Production • Outlicensing

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