This decision will be based on three key factors:
- Test results obtained against specific cancer targets using GAP-107B8 and variants, and the observed behavior of the drug using the different routes of administration commonly found in the clinic for the cancer indications under investigation
- The absence of or deficiencies in current standard of care
- Any accelerated approval programs available for the selected cancer type
Tests to date have shown efficacy in treatment of a range of cancers. Bladder cancers using intravesical administration, and ovarian cancers using intraperitoneal administration are being assessed as potential first candidates for clinical trials. Both routes of administration are recognized as viable clinical delivery methods for the applicable cancer type.
PharmaGap's prime objective in the first half of this year is to select the single cancer target and clinical formulation of GAP-107B8 that will provide the Company with the best opportunity for successful completion of all regulatory requirements to be met in order to commence clinical trials in the first half of 2012.
Key activities underway to support this decision include in vitro and in vivo testing of GAP-107B8 at collaborator sites previously announced, as well as a range of in vitro testing at PharmaGap characterizing candidate dosage forms intended for use in in vivo tumour model studies and subsequent human trials.
Bioanalytical, pharmacokinetic, and toxicology profiling for both intraperitoneal (for ovarian) and intravesical (for bladder) delivery systems has commenced and will be ongoing through the first half of 2011, both internally and at contract research organizations.
Formulation work, which is underway, includes investigation into the effect of excipients to the core active pharmaceutical ingredient ("API") that is central to GAP-107B8's activity, as well as to investigation and development of the final dosage form of product for use in humans. This formulation work has as its principal objective the delivery of the most efficacious dose of GAP-107B8 to the site of the chosen cancer target, with maximum uptake of the drug into the tumour vasculature, while promoting stability and minimizing any potential side effects.
Also during this period discussions will continue with peptide manufacturers with cGMP production capabilities for GAP-107B8 with the objective of selecting a peptide manufacturer for production of GAP-107B8 for clinical use.
Following the selection of cancer target and determining the preferred route of administration of the dosage form for first clinical trials, the Company will proceed with the generation of all data required in order to meet the non-clinical regulatory requirements in Canada and the United States to apply for approval for the first clinical trial for GAP-107B8.
Dr. Ken Sokoll, Chief Operating Officer and Vice President Clinical Affairs, expressed confidence with the position of PharmaGap and the advancement of the program toward clinical trials: "The program to move our peptide into clinical trials is demanding but achievable. Each of the cancer types now being assessed has significant incidence and unsatisfactory treatment alternatives. It is exciting and rewarding to lead this program that holds promise of bringing to trials a potentially significant new treatment choice for patients" Dr. Sokoll said.