Phase I Clinical Trial

Phase I Clinical Trial of TetraAs.

PRINCIPAL
INVESTIGATOR
(CONDUCTING PHASE 1)

Seoul Asan Medical Center

PERIOD OF
CLINICAL TRIAL

2004.02~2004.07: Medication of TetraAs for 4 weeks each to the patients accordingly

PARTICIPANTS

* 15 patients with terminal cancer to whose the cancer treatments such as surgical operation, chemotherapy and radiotherapy had previously been unsuccessful
– 4 patients with cervical cancer
– 4 patients with transitional cell carcinoma
– 5 patients with head and neck cancer
– 1 patient with gastric cancer
– 1 patient with colon cancer

RESULTS

Ten out of 15 patients (66.7%) had a decreased tumor (or tumor stopped growing) and most participants experienced an improvement in their quality of life due to pain reduction

  1. Decrease in size of tumor, decrease in SCC-Ag level
  2. Tumor necrosis and formation of fistula
  3. No serious side effects were observed
  4. Improvement of life quality without vomit and abdominal pain (stomachache)
  5. Applicable to various cancers and oral administration the most convenient mode of drug delivery
  6. Great synergic effect in combination cancer therapy with conventional treatments

Stage 1-3 Clinical Trial Case (Asan Medical Center)

PATIENT

1-3 stage / 40 years / Female / Cervical Cancer

CASE REVIEW

23_clinical_0726_01

2004/02/23

68.9(SSC Ag)

23_clinical_0726_02

2004/03/30

29.8(SSC Ag)

Three doses of TetraAs 5mg

Significant reduction in tumor size
Improvement in quality of life

Stage 1-2 Clinical Trial Case (Asan Medical Center)

PATIENT

1-2 stage / 66 years / Female / Cervical Cancer

CASE REVIEW

23_clinical_0726_03

2004/02/23

34(SSC Ag)

23_clinical_0726_04

2004/04/24

25.3(SSC Ag)

23_clinical_0726_05

2004/06/22

17.5(SSC Ag)

Three doses of TetraAs 5mg

Reduction in tumor size,
Improvement in quality of life

Stage 1-1 Clinical Trial Case (Asan Medical Center)

PATIENT

1-1 stage / 53 years / Male / Nasopharyngeal Cancer

CASE REVIEW

23_clinical_0726_06

2004/02/23

23_clinical_0726_07

2004/03/26

23_clinical_0726_08

2004/04/24

Three doses of TetraAs 15mg

Significant reduction in malignant
tumor size Disappearance of rhinorrhea
and bad smell Daily life is possible

Stage 3-1 Clinical Trial Case (Asan Medical Center)

PATIENT

3-1 stage / 43 years / Female / Cervical Cancer

CASE REVIEW

23_clinical_0726_09
23_clinical_0726_10
23_clinical_0726_11
23_clinical_0726_12

Three doses of TetraAs 15 mg

Discontinued due to
dose-limiting toxic effect

(10mg 3Times / 5mg 3Times)

Stage 3-2 Clinical Trial Case (Asan Medical Center)

PATIENT

3-2 stage / 31 years / Male / Tongue Cancer

CASE REVIEW

23_clinical_0726_13
23_clinical_0726_14
23_clinical_0726_15
23_clinical_0726_16

Three doses of TetraAs 15 mg

Discontinued due to
dose-limiting toxic effect

(10mg 3Times / 5mg 3Times)

Report of Phase 1 Clinical Trial
Exploratory study of tumor response (Conclusion of Clinical Trials)

In this clinical trial, no adverse drug reactions were observed. Especially considering the fact that this clinical trial was conducted on 15 patients with terminal cancer whose previous treatments had been largely unsuccessful (including surgical operations, anti-cancer chemotherapy and radiotherapy), it is noteworthy that 10 out of 15 patients saw their cancer tumor size reduced and found that the progress of their cancer was stalled, as a result of their treatment with TetrAs. There was also a significant decrease in the tumor marker (SCC Ag) in 2 cases of cervical cancer (in case of R-01, decreased to 29.8 from 68.9 and R-02, decreased to 17.5 from 34).

During the clinical trial it was found that the drug blocks the vessels distributed around the tumor, which cause fistulization and tumor necrosis. Since one of mechanisms of this drug is anti-angiogenesis, which was confirmed in laboratory experiments and animal testing, the therapeutic benefits of this drug are possibly due to the drug’s effect on blood vessels. Currently, the so-called target therapy being developed globally does not cause a reduction in tumor size when used alone but when the target therapy is used in combination with other anti-cancer drugs, it increases the response rate of cancer treatment and extends the life of patients. Therefore, the drug under investigation should be approved for the next clinical trial phase to be used alone or in combination with other conventional treatment.

It is considered a merit of this drug that in patients with cervical cancer, a reduction in tumor marker and tumor necrosis was shown following a dose of 15 mg/day with almost no adverse effects.

Search