Personalize Etoposide Chemotherapy Toward Small Cell Lung Cancer (SCLC) With Maximizing Effectiveness and Minimizing Risk Via Assay Single Nucleotide Polymorphisms (SNPs) of Relative Etoposide Targets, Topoisomerase II and CYP4503A4

Trial Information

Personalize Etoposide Chemotherapy Toward Small Cell Lung Cancer (SCLC) With Maximizing Effectiveness and Minimizing Risk Via Assay Single Nucleotide Polymorphisms (SNPs) of Relative Etoposide Targets, Topoisomerase II and CYP4503A4

Targeted SCLC chemotherapy with VP-16 and personalized patient-specific biomarkers (SNPs)

We obtained the IND 78,420 Exemption Letter from FDA like as Drug Sponsor on 04/29/2009. In
future, any IND is not required to conduct our further relative clinical studies. // We
obtained the NCI Investigator ID 49256 from NCI like as Clinical Investigator on 01/08/2012.
// We obtained DHHS and IRB approval document: Federal-wide Assurance (FWA) for the
Protection of Human Subjects for Institutions within the United States (FWA: 00015357). So
we can develop our further relative clinical studies in USA.

Our Further Retrospect Clinical Study will use Combined Chemotherapy on ETOPOSIDE INJECTION
plus CISPLATIN INJECTION to treat Small Cell Lung Cancer (SCLC) patients, and will try to
look for the relationship between the ETOPOSIDE INJECTION therapeutic efficacy and the
Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE INJECTION
Adverse Drug Reaction and the CYP4503A4 SNP Genotyping, based on precisely sequencing drug
targets' genes.

The treatment option must be ETOPOSIDE INJECTION plus CISPLATIN INJECTION, but the the
specific SCLC patients, who had used the ETOPOSIDE INJECTION plus CISPLATIN INJECTION until
right now, have had to survive over 2 years.

According to Etoposide Injection Directions, the Etoposide efficacy target may be
Topoisomerase II and the Etoposide metabolism target should be relative to CYP4503A4. // We
hope to discover the Topoisomerase II SNP Genotypes which could be more relative to higher
therapeutic efficacies, and the CYP4503A4 SNP Genotypes which could be more relative to
lower Adverse Drug Reactions.

We will assay Single Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target
(Topoisomerase II) which are relative to maximizing effectiveness, and will assay Single
Nucleotide Polymorphisms (SNPs) of Etoposide (VP-16) drug target (CYP4503A4) which are
relative to minimizing risk in the specific SCLC patients who are surviving after 2 years
used Combined Chemotherapy on ETOPOSIDE INJECTION plus CISPLATIN INJECTION, based on
precisely sequencing drug targets' genes.

In the Retrospect Stage, every patient's Combined Chemotherapy Plan must use the same
Oncology Drugs' Combination - ETOPOSIDE INJECTION plus CISPLATIN INJECTION as the patient
used at all times since 2 years ago until right now. // In the Retrospect Stage, all of SCLC
patients msut be used the same Combined Chemotherapy Plan or Oncology Drugs' Combination -
ETOPOSIDE INJECTION plus CISPLATIN INJECTION. // In the Retrospect Stage, the Combined
Chemotherapy Plan or Oncology Drugs' Combination must the ETOPOSIDE INJECTION plus CISPLATIN
INJECTION. // All of oncology drugs must be approved by USA FDA and must be sold on USA
market legally. // The dosages about all of oncology drugs must abide by their labeling in
USA. // All of Adverse Drug Reactions for all of oncology drugs in our clinical studies must
be provided most suitable and professional symptomatic treatments.

We need use the SCLC patients' tissue or humoral specimens to assay the Topoisomerase II SNP
Genotypes and the CYP4503A4 SNP Genotypes with precisely sequencing drug targets' genes in
USA.