Canji, Inc. 
Telephone: (619) 597-0177 
9.3 Case Report Forms (CRT): Computerized CRF's will be provided by Canji, Inc 
10.0 DRUG PREPARATION, FORMULATION, AND AVAILABILITY 
10. 1 The study drug, ACN53, will be prepared and provided by Canji, Inc., San Diego, CA. 
10.2. Pharmaceutical data, including formulation, manufacturing, and potency is 
described in Appendix E. 
11.0 RESPONSE CRITERIA 
Tumor response to ACN53 is not a primary objective of this study. However, 
observations of antitumor activity will be collected. 
11.1 Standard criteria will be formally employed to classify the antitumor responses 
observed in patients with measurable disease in the liver. Measurable disease will 
consist of bidimensionally measurable liver lesions with perpendicular diameters of 
> 1 cm x > 1 cm. 
11.2 Definitions: 
11.2.1 Complete Response (CR): 
CR will consist of complete disappearance of all evidence of disease 
lasting for > 28 days. 
1 1 .2.2 Partial Response (PR): 
PR will consist of a 50% or greater reduction in the sum of the products 
of the perpendicular diameters of all measurable lesions lasting for > 28 
days. Every individual lesion need not regress for classification as PR. 
However, progression (as defined in 12.4) of any individual lesion or the 
appearance of new measurable lesions negates the classification as PR, 
and may constitute a mixed response (see 12.1.6). 
11.2.3 Minor Response (MR) : 
MR will consist of a 25-50% reduction in the sum of the products of the 
perpendicular diameters of all measurable lesions lasting for > 28 days. 
Every individual lesion need not regress for classification as MR. 
However, progression (as defined in 12.4) of any individual lesion or the 
appearance of new measurable lesions negates the classification as MR 
and may constitute a mixed response (see 12.1.6). 
1 1 .2.4 Stable Disease (SD): 
SD is defined as neither response (CR, PR, MR) or progression (PD). 
11.2.5 Progression (PD): 
[ 688 ] 
Recombinant DNA Research, Volume 20 
