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Exploring Opportunities in Niche Therapies – Human Cytomegalovirus (HCMV) Infections

April 2018 | 42 pages | ID: E8B329B9FB7EN
ProGrow Pharma Partners

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The spectrum of diseases caused by Human Cytomegalovirus (HCMV) is diverse.Most CMV infections are “silent,” where the infected people exhibit no signs or symptoms posing no serious problems, but this infection can become a cause of morbidity /mortality in immunocompromised patients and new-borns where the immunity barrier is low .Two major areas where prevention or better treatment of CMV infection is urgently required worldwide is in Transplant (organ, bone marrow) and Congenital CMV infection . In the US alone approximately 5,000 U.S. infants develop permanent problems due to CMV, some of them severe, including deafness, blindness, and mental retardation. CMV is among the most common infections following solid-organ transplantation and hematopoietic stem cell transplant procedures, causing disease, transplant complications. Drugs with new MOA and vaccines need to be developed soon to meet the unmet needs for CMV infections. Approximately 70,000 allogeneic HCT procedures are performed annually worldwide. Currently there is no marketed CMV vaccine for these patients. In this report we discuss the recently approved therapies for CMV infections, other drugs and vaccines in the pipeline and the challenges associated with the development and commercialization
1. EXECUTIVE SUMMARY

2. DISEASE OVERVIEW

a. Biology- Human CMV (HCMV)
  Congenital and Neonatal HCMV Infection
  HIV
  Solid Organ Transplant (SOT)
  Hematopoietic Stem Cell Transplantation (HSCT)
b. Diagnosis
  Laboratory Tests
  Imaging
c. Epidemiology

3. UNMET NEED

a. Congenital CMV Infection – No Prophylactic Vaccine yet!
b. Why is this Opportunity not on the “Wish List” of Major Pharma Companies?

4. MARKET OPPORTUNITY

5. TREATMENT PARADIGM FOR HCMV INFECTIONS IN TRANSPLANT AND NEWBORN

a. Antiviral Therapies
  Ganciclovir (9-[(1,3-dihydroxy-2-propoxy)methyl]guanine)
  Valganciclovir (Valcyte)
  Foscarnet/Foscavir
  Cidofovir/Vistide
  Letermovir/PREVYMIS
  HCMV-Specific Hyperimmune Globulin
b. Clinical Pipeline – Small Molecules
  Maribavir – Phase III – Shire/Viropharm
  Intravenous brincidofovir (IV BCV, Ph1)- Chimerix
  ATA230- Atara Therapeutics- Phase I/II
  ANPs- Therapeutic Systems Research Laboratorie Inc (Pre-Lead)
c. Clinical Pipeline – Vaccines
  Triplex and PepVex
  CyMVectin (PC / Phase I)
  HB-101: Phase II


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