Phase I Clinical Trial

Phase I Clinical Trial of CM-7919

PRINCIPAL
INVESTIGATOR

Seoul Asan Medical Center

PERIOD

2004.02 ~ 2004.07: CM-7919 was administered for 4 weeks to each patients according to cohorts

PARTICIPANTS

15 patients with terminal cancer whose previous treatments such as surgical operation, chemotherapy and radiotherapy was 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

10 out of 15 patients (66.7% response rate) had decrease in tumor size (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 and SCC-Ag level
  2. Tumor necrosis and formation of fistula
  3. No serious side effects were observed
  4. Improvement of life quality without vomit or abdominal pain
  5. Showed positive results that CM-7919 works on various cancers and oral administration is one of the advantages of CM-7919, making the drug administration convenient
  6. Great therapeutic synergy when combined with conventional treatments
Phase 1 Clinical Trials Report
Exploratory study of tumor response

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, chemotherapy and radiotherapy), it is highly notable that 10 out of 15 patients experienced reduction in tumor size or stop in tumor growth. 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 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 CM-7919 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 worldwide does not cause reduction in tumor size when used alone but when the target therapy is used in combination with other 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 an advantage of this drug that cervical cancer patients experienced reduction in tumor marker and tumor necrosis following a dose of 15 mg/day with almost no adverse effects.

Stage 1-3 Case (Phase I at 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 CM-7919 5mg

Significant reduction in tumor size
Improvement in quality of life

Stage 1-2 Case (Phase I at 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 CM-7919 5mg

Reduction in tumor size,
Improvement in quality of life

Stage 1-1 Case (Phase I at 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 CM-7919 15mg

Significant reduction in malignant
tumor size
Disappearance of rhinorrhea

and bad smell
Quality of everyday life improved

Stage 3-1 Case (Phase I at 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 CM-7919 15 mg

Discontinued due to
dose-limiting toxic effect

(10mg tid > 5mg tid)

Stage 3-2 Case (Phase I at 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 CM-7919 15 mg

Discontinued due to
dose-limiting toxic effect

(10mg tid > 5mg tid)

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