ST Pharm, registered a global phase I of STP1002

Recruitment of subjects started in the US from August

A US clinical trial of a new oral colon cancer treatment drug being developed by ST Pharm is on track.

 

One out of three local clinical trial institutions that announced their entry this year began recruiting subjects, taking the first step toward commercialization.

 

According to clinicaltrials.gov operated by the National Institutes of Health (NIH) on the 14th, ST Pharm recently registered a new global phase I clinical trial plan related to the new chemical synthesis drug 'STP1002'.

 

This test is the first FIH (first-in-human) clinical trial to administer the world's first oral colon cancer treatment 'STP1002' by ST Pharm to humans.

 

The purpose is to confirm the maximum tolerated dose (MTD) of STP1002 in 30 adult patients with advanced solid cancer, and to confirm safety, tolerability, and pharmacokinetics (PK) characteristics.

 

The primary efficacy evaluation criterion is dose-limiting toxicity(DLT) and severe adverse events that may be associated with test drug administration.

 

As secondary efficacy endpoints, treatment emergent adverse event (TEAE) occurred during the treatment period and plasma concentration after oral administration of STP1002 are evaluated.

 

ST Pharm's 'STP1002' was approved by the US Food and Drug Administration (FDA) in December last year for Phase I Clinical Trial Plan (IND).

 

In June of this year, three institutions, including the University of Southern California, the University of Colorado, Denver, and Northwestern University, began clinical trials.

 

Last month, CU Denver was the first to start administering test drugs to subjects.

 

Registered subjects are classified into 5 cohorts, taking the prescribed dose of STP1002 for 21 days once a day and following a schedule with a 7-day withdrawal period.

 

The plan is to complete all schedules related to phase I clinical trial such as recruiting subjects, taking test drugs, and analyzing results by next July.

 

Animal test results of STP1002 (Source: ST Pharm IR)

ST Pharm derived STP1002 through a two-year joint research with the Korea Research Institute of Chemical Technology from 2014.

 

It is a candidate substance for a synthetic new drug that inhibits the growth of cancer cells by inhibiting the enzyme Tankyrase.

 

ST Pharm expects that STP1002 will have a therapeutic effect on colon cancer patients who are resistant to Erbitux, an existing colorectal cancer treatment, or have a mutant genotype such as K-RAS and N-RAS.

 

According to ST Pharm, as a result of a 4-week repetitive preclinical toxicity test on an animal model transplanted with cancer cells derived from colon cancer, STP1002 was not associated with significant toxicity and side effects.

 

It showed differentiation compared to anticancer drugs.

 

In the efficacy evaluation, the response rate of Tumor Growth Inhibition (TGI) was 49-70% and excellent tumor suppression effect was proved.

 

ST Pharm is developing 'STP1002' as an oral drug that is taken once a day.

 

Given that existing colon cancer treatments such as Erbitux and Avastin are IV formulations, it is evaluated that they have the potential to replace the $1.9 billion colon cancer treatment market based on convenience of use if they are successfully commercialized.

 

After securing colon cancer as the first indication, it plans to expand the indications to non-small cell lung cancer, breast cancer, and liver cancer through combination with drugs of other mechanisms, such as immuno-anticancer drugs.

 

ST Pharm is implementing an Innovative Virtual R&D strategy with low cost and high efficiency while actively utilizing internal and external networks such as Dong-A ST, the Korea Research Institute of Chemical Technology, and Asan Medical Center in Seoul.

 

Currently, it is carrying out new drug tasks such as non-alcoholic steatohepatitis (NASH) treatment, influenza treatment, viral infection treatment such as polio, and oral anticoagulant.

 

In addition to the colon cancer treatment 'STP1002', AIDS treatment 'STP0404' is about to enter clinical trials as Phase I Investigational Medicinal Product Dossier(IMPD) in France was approved at the end of April.

 

When the French local clinical trial of STP0404 begins in earnest, a total of two global clinical trials will be conducted simultaneously.