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KOMINOX

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  1. 1 Phase II Clinical Trial on 14 metastatic cancers, including Brain metastases and Lung cancer(PJ Code: PAX-1-003)go
  2. 2 Phase II Clinical Trial on Glioblastoma Brain Cancer (GBM) (PJ Code: PAX-1-002)go
> Phase II Clinical Trial on 14 metastatic cancers, including Brain metastases and Lung cancer(PJ Code: PAX-1-003)

RATIONALE

· Currently available cytotoxic anticancer drugs primarily target mature cancer cells. They do not target cancer stem cells, which are the progenitors of highly proliferating cancer cells. Hence, currently available drugs are limited in controlling the spread of metastatic and recurrent cancers in mammals with immune systems (Karmanos paper, Capacity of cancer stem cells).
· Cancer stem cells eventually lead to malignant metastatic cancers. Cancer stem cells must be eliminated to effectively treat metastatic cancers.
· KOMIPHARM’S research indicates that cancer stem cells are responsible in nearly all cases of metastatic cancer pathologies. The new drug (PAX-1) being developed by KOMIPHARM eliminates 99% of cancer stem cells that lead to metastatic cancer (Karmanos paper, Capacity of cancer stem cells).
· Currently available treatments for brain-related cancers have a low Blood Brain Barrier (BBB) transit rate, and thus have limited efficacy. There are also limited effective treatment options for lung cancers.
· KOMIPHARM’S PAX-1 has a high 98% Blood Brain Barrier (BBB) transit rate and remains active in the brain for 72 hours to eliminate cancer stem cells. PAX-1 has also been shown to be effective in treating lung cancer, by targeting and eliminating metastatic lung cancer stem cells.
















Current Status of the 14 Metastatic cancers clinical trials

· As of August 2019, the FDA are reviewing the clinical basket trial application on 14 metastatic cancers in which 240 participants will be divided into 5 cohorts to test KOMIPHARM’S PAX-1.
· The 14 types of metastatic cancers being researched are: non-small cell lung carcinoma, lymph non-small cell lung carcinoma, metastatic breast cancer, metastatic soft-tissue cancer, metastatic osteosarcoma, metastatic gastric cancer, metastatic renal cancer, metastatic ovarian cancer, metastatic bladder cancer, metastatic cervical cancer, metastatic endometrial cancer, metastatic head and neck cancer, metastatic prostate cancer and malignant melanoma.
· The clinical trial is expected to commence in the second half of 2019 (prospective), where nanotechnological methods will be used to verify the extent of cancer stem cell eradication by the new drug. We are expecting highly successful results for this study, consistent with successful results of previous clinical trials.
















> Phase II Clinical Trial on Glioblastoma Brain Cancer (GBM) (PJ Code: PAX-1-002)

RATIONALE

· The World Health Organization (WHO) classifies GBM cancer as a Grade 4 malignant cancer, which is the fastest growing and most dangerous category.
· GBM is a cancer that occurs in the brain and cancer cells are attached to neurons. As neurons cannot be directly operated on, cancer cells remain there even after surgery and treatment.
· Mammals have a Blood Brain Barrier (BBB) which limits the absorption of many drugs entering the brain. Temozolomide (TMZ), which is the current standard treatment used in GBM only has a 20-30% BBB transition rate, limiting its efficacy.
· KOMIPHARM’S PAX-1 has a 98% BBB transition rate due to its special Arsenic based molecular structure (MDS Pharma USA study).
· PAX-1 has demonstrated excellent selective cancer cell eliminating capabilities in the interim results, and can greatly improve outcomes in GBM patients unresponsive to TMZ
· PAX-1’s efficacy will be tested against 10 most prevalent GBM cell line types. The results are measured using nanotechnological methods, and PAX-1’s killing effects have been observed in all runs so far. 4 of the tests done have shown especially promising results with a high cancer cell sensitivity to PAX-1
· Therefore, there is a high likelihood of PAX-1 becoming the standard treatment for glioblastoma brain cancer (GBM) in the future




















About the Clinical Trial on GBM cancer

· The GBM clinical trial is conducted in collaboration between the Prince of Wales Private Hospital (Sydney, Australia) and Scientia Clinical Research · The study is being led by world-renowned neurosurgeons Dr. Charlie Teo and Dr. Michael Sughrue, working together with 3 other acclaimed specialists from Scientia Clinical Research
· The sample size is projected to be 80 patients aged 18-70, both male and female. 40 patients are newly diagnosed with GBM, and the other 40 are those who have relapsed or recurrent GBM cancer following surgery. The clinical trial is projected to submit an Orphan Drug Designation (ODD) application with the FDA during the study, and the sample size may increase with the FDA’s marketing authorisation
· The prognosis is a high probability of cure, so the results of this study are highly anticipated in the medical community
· GBM cancer affects 19,000 people a year in the USA alone, but it is still considered a relatively uncommon disease. PAX-1 is eligible to receive government incentives as an Orphan drug for treatment of this debilitating disease
· KOMIPHARM has completed construction of its GMP accredited manufacturing facility and equipment
· Therefore, following commercial manufacturing approval, KOMIPHARM expects a smooth transition to recruitment, supply and sales to countries around the world