From Bench to Bedside—An Example of an In Situ Hydrogel in In Vivo Applications - In-Situ Gelling Polymers: For Biomedical Applications - page 212

Regel +
Paclitaxel

Non-Clinical
studies

OncoGel

Safety
evaluation

Tissue
studies

In combination
with surgery

Spinal cord

Rat

Animal
model
studies

Brain

OncoGel as an anti-cancer
therapeutic drug.

Pig In combination

withTMZ

Pancreas In combination

with radiation

Phase -
tumor
lesions.

Phase 2a-Esophageal
cancer(RT+Oncogel)

Termination
(Esophageal
cancer)

Phase 2b-Esophageal
cancer(CT+Oncogel)

Clinical Trials on Humans

Scheme 1 Flowchart of the development of Oncogel

therapies. Thus complimentary cancer based cellular mechanisms can be targeted
by combining Oncogel with systemic chemotherapy or surgeries. Moreover, pacli-
taxel's anti-neoplastic and radiosensitization activities can be exploited by com-
bining Oncogel with radiotherapy to increase efficacy of the cancer therapy [ 9 ,
10 ]. The development of Oncogel is highlighted in Scheme 1 .

2 Non-clinical Safety and Efficacy Evaluation

Several non-clinical studies were performed to explore Oncogel's anti-cancer activ-
ity and evaluate its biomedical applications. These included establishing its safety
and tolerability Vis-a-Vis systemic administration of Paclitaxel and illustrating its
localization within and around the tumor site. Emphasis was also laid on proving its
efficacy as a standalone treatment and its tolerability in combination therapy [ 5 ].

2.1 Safety Studies

Before targeting the primary cancer cells with Oncogel, it was necessary to estab-
lish local tolerability of the system in normal tissue. Various studies were con-
ducted on rats, dogs, pigs to evaluate the safety of Oncogel when delivered to the
following tissues: skin (subcutaneous injection), central nervous system (CNS),