Before
the FDA will approve a drug, the sponsoring company must conduct several
clinical studies. The studies are done in phases to determine what
the side effects of the drug are and how effective it is in treating
the disease. The earliest studies (pre-clinical, meaning in the lab
before they are given to people) are to determine if the drug works
in the way it was thought to work. The pre-clinical phase looks at
the safety of the drug before it is given to anyone. Phase I trials
evaluate the safety of the new therapy in a small number of human subjects.
Phase II trials investigate the new therapy's safety in a larger group
of humans and will determine the most effective dose and duration.
BiovaxID™ is currently undergoing Phase III clinical trials,
which is the last part of the clinical development process. In these
studies, a large number of patients are treated with the dose regimen
that was identified in the earlier trials in order to prove that
the new medication is both safe and effective for its intended therapy.
When the clinical trials are complete, these data will be submitted
to the FDA for review. When the FDA has completed its review and
makes a determination that the safety and efficacy have been satisfactorily
proven, it approves the new drug.
For more information, please visit our page on BiovaxID™ Immunotherapy
Vaccine for Non-Hodgkin's Lymphoma
To find answers to the most frequently asked questions on Non-Hodgkin's
Lymphoma, please visit our Non-Hodgkin's
Lymphoma FAQ or our Physician's
Information Section on BiovaxID™
BiovaxID™ Phase
III Trial Enrollment Questions: 1-877-654-6052
Clinical Site Locations
Florida
Cancer and Blood Disease Center
521 N. Lecanto Highway
Lecanto, FL 34461
Principal Investigator: Gustavo Fonseca, M.D.
Study Coordinator: Joyce Winder, RN
Phone: 352-746-0707
R. Lee Moffitt Cancer Center
12902 Magnolia Ave.
MRC 4 East Room 4072 H
Tampa, FL 33612-9497
Principal Investigator: Gregoire Bergier, MD
Study Coordinator: Stacy Moss
Phone: 813-745-8391
Georgia
Emory University
Winship Cancer Institute
1365C Clifton Road NE
#3006
Atlanta, GA 30322
Principal Investigator: Christopher Flowers, MD
Study Coordinator: Courtney Johnson
Phone: 404-778-3575
Hawaii
Hawaii Pacific Health Research Institute
55 Merchant St.
Honolulu, HI 96813
Principal Investigator: Ian Okazaki, M.D.
Study Coordinator: Lori Keith
Phone: 808-547-5925
Illinois
Robert H. Lurie Comprehensive Cancer Center
Northwestern University
676 N. St. Clair, Suite 850
Chicago, IL 60611
Principal Investigator: Jane Winter, M.D.
Study Coordinator: David Patton, CCRC
Phone: 312-695-4538
Massachusetts
New England Medical Center
Tufts University School of Medicine
750 Washington St.
Boston, MA 02111
Principal Investigator: Andreas Klein, M.D.
Study Coordinator: Jamie Hill
Phone: 617-636-4998
Mississippi
North Mississippi Hematology and Oncology Associates
990 South Madison
Tupelo, MS 38801
Principal Investigator: Christopher Croot, MD
Study Coordinator: Marthe Thomas
Phone: 662-844-9166
New York
NYU School of Medicine
NYU Cancer Institute
550 First Avenue
New York, NY 10016
Principle Investigator: Franco Muggia, M.D.
Study Coordinator: Andrea Downey RN
Phone: 212-263-5466
Westchester Oncology and Hematology
19 Bradhurst Ave
Hawthorne, NY, 10532
Principle Investigator: Tauseef Ahmed, MD
Study Coordinator: Judy Laumuanpuii, MD
Phone: 914- 594-4000 ext 111
North Carolina
Duke Comprehensive Cancer Center
Morris Building
Durham, NC 27710
Principal Investigator: Jon Gockerman, M.D.
Study Coordinator: Sue Roth
Phone: 919-681-4769
Pennsylvania
Hospitals of the University of Pennsylvania
3400 Spruce Street
16 Penn Tower
Philadelphia, PA 19104
Principal Investigator: Steven Schuster, M.D.
Study Coordinator: Brenda Horn
Phone: 215-617 1812
Texas
M.D. Anderson Cancer CenterNew
University of Texas
1515 Holcombe Boulevard
Houston, TX 77030
Principal Investigator: Sattva Neelapu, M.D.
Study Coordinator: Kim Hartig
Phone: 713-792-4249
Washington
Puget Sound Cancer Centers
1560 N. 115 th Street
Suite G-16
Seattle, WA 98133
Principal Investigator: David Dong, M.D.
Study Coordinator: Karen Zapata, RN
Phone: 206-365-8252
Sites Outside the US:
Please call us at 1-877-654 6052 for information about clinical sites in Russia and the Ukraine.
