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Vaccines for Clinical Development


Vaccines in Clinical Development
Vaccine R&D Pre-Clinical Phase I/II Phase IIb Phase III
dates reflect estimated completion date; TBD, to be determined
JRC-LAMP-vax
Allergy Immunotherapy
Q4 09 Q2 10 Q4 10 Q1 12
SRW-LAMP-vax
Allergy Immunotherapy
Q1 09 Q4 09 Q2 10 Q4 10 Q1 12
GRNVAC1/2
Cancer Immunotherapy
2009 TBD
Argotom-VAX
Therapeutic HIV
Q4 09 Q3 10 Q2 11 TBD

Additional information on each vaccine can be found below by following the link. Details about LAMP-vax Technology can be found on our Technology Page.

What Is The Clinical Trial Process?

Every therapeutic, diagnostic and medical device must be reviewed and approved by the Food & Drug Administration (FDA). Moving a product through the clincial trial process can seem like a daunting task, however, with skill and a professional relationship with the FDA, things can move along smoothly and within a reasonable budget.



JRC-LAMP-vax – An Immunotherapeutic Vaccine for Japanese Red Cedar Pollen

The field of allergy vaccines, in particular DNA allergy vaccines, represent one of the most attractive and significant market opportunities as well as one of the simplest targets (or families of targets). Researchers at the University of Singapore have demonstrated that a LAMP-based DNA vaccine induces a critical “re-training" response in the immune system, enabling it to recognize an allergen as an antigen and most importantly to convert an allergic reaction into an immune response. Our first products are for Japanese Red Cedar (JRC) and Short Ragweed (SRW).

ITI has developed a vaccine formulation that targets the major allergens and is preparing to meet with the FDA as part of the Company’s plan to initiate a clinical study. Additional information about the vaccine design and our technical approach can be found on our Technology Page.

SRW-LAMP-vax – An Immunotherapeutic Vaccine for Short Ragweed Pollen


Similar to the JRC vaccine, ITI plans to develop and evaluate an immunotherapeutic vaccine for short ragweed, the leading cause of hay fever in North America. Back to Top

GRNVAC1 – An Immunotherapeutic Vaccine for Cancer Targeting Telomerase

ITI issued a license to the Geron Corporation to incorporate LAMP technology into their therapeutic cancer vaccine, GRNVAC1 in 2006. They have already completed a published study in human prostate cancer patients and are now pursuing additional studies. According to Geron's website, www.geron.com their cancer vaccine program “is based on autologous dendritic cell delivery of the telomerase antigen to induce a cellular immune response. Geron is currently sponsoring a Phase II clinical trial of GRNVAC1 in patients with acute myelogenous leukemia (AML). Geron is also developing an allogeneic telomerase vaccine candidate (GRNVAC2) based on dendritic cells derived from human embryonic stem cells."

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Argotom-VAX– An Immunotherapeutic Vaccine for HIV

Argotom-VAX Therapeutic HIV is a collaborative project with Genoa Biotec (Sao Paulo, Brazil) and Johns Hopkins University; the vaccine is intended to treat HIV – infected individuals following ART treatment with the goal of extending the period of hypoviremia and reducing the dependency on HIV anti-viral drugs. Therapeutic vaccines for HIV are attractive because they can significantly improve the health of the patient while reducing their cost of care. In addition, we believe that the LAMP HIV vaccine would satisfy the FDA’s definition of experimental drugs intended to treat life threatening diseases, thereby enabling an expedited review and approval process. Although a valuable and repetitive therapy, it is important to note that due to the highly variable nature and the inherent biology of HIV, it is not a cure for those infected. Back to Top


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