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Onselex Executive Summary

관리자 2023-10-09 21:45:32 Views 954

Onselex is a pioneer biotechnology company developing a novel class of drugs based on nanoparticle delivery to treat cancer and neurological diseases. Onselex developed new drugs built upon advanced nanoparticle encapsulation technology. Targeted administration of certain oncology medications based on its proprietary nanoparticle technology will reduce adverse reactions arising from the toxicity of oncology medications by more than 95 percent—compared to typical standard chemotherapy treatments—thereby significantly reducing cancer patients' suffering and effectively increasing the likelihood of complete recovery. 

 

Company promotional video link (bottom web page):

https://onselex.com/en/sub/sub04_01.php?boardid=newsen&mode=view&idx=7

 

Onselex’s focus on nanoparticle delivery, anti-cancer drug candidates, and cellular targets provides a platform for developing potent therapeutics whose mode of action directly impacts critical oncologic cell functions. Much in vitro and in vivo research supports Onselex’s strategy of creating an entirely new family of drugs based on Nanoparticle-Loaded drugs (ONX-1006), using Paclitaxel. Extensive studies conducted and published at renowned universities such as MIT and corroborated by independent laboratories with the National Cancer Institute and other academic institutions around the world published many research papers that Nanoparticle-Loaded drugs have demonstrated their effectiveness in delivering anti-cancer drugs into every tumor if the nanoparticle drugs can overcome the nanoparticle manufacturing and toxicity issues

 

Despite many advances in medicine, pancreatic cancer remains elusive with limited treatment options with very poor prognosis at 75% mortality within a year and 90% within 5 years.  Pancreatic cancer is often diagnosed in late stages with metastasis.  The cancer therapeutic community has for decades sought to cure pancreatic cancer with many robust therapeutic attempts but most failed to achieve successful efficacy.  However, Onselex's ONX-1006 impressive pre-clinical data suggest successful pancreatic treatment is finally within reach.  The current pancreatic cancer therapies are folfirinox and Abraxane. The pancreatic cancer drug, 125 mg/m2 of Abraxane in combination with Gemcitabine (1,000mg) is the effective therapy available which prolongs life only on average of about 1.8 months. In the xenograft efficacy test, our ONX-1006 achieved a statistically far superior and significant anticancer effect (3x+) compared to Abraxane's existing pancreatic cancer drug. Based on these data, Onselex projects ONX-1006 will reduce the pancreatic cancer death rate more than 70% with very minimum or no side effects.



Outstanding ONX-1006 Efficacy and Toxicity Results:

Our Nanoparticle ONX-1006 GLP toxicology data shows that it can be safely administered to cancer patients over 20x current chemotherapy drug (Paclitaxel, PTX) dose without any harmful side effects. The lethal Paclitaxel dosage to rat is ~12 mg/kg. The single IV dose rat GLP toxicity study indicated that ONX-1006 (PTX 500mg/kg) Approximate Lethal Dose (ALD) is 40x-50x current PTX lethal dosage to rats, without any harmful side effects.   The current PTX maximum tolerated dose (MTD) for dogs is PTX 8.25 mg/kg but ONX-1006 is safe even at PTX 25 mg/kg+ or 3x the MTD.  Due to their severe toxicity, Taxol-based chemotherapy drugs do not have a No Observed Adverse Effect Level (NOAEL).  However, ONX-1006 achieved remarkable NOAEL value at every GLP test with Rats and Beagle dogs, including ONX-1006 Thirteen-Week Repeated IV (Once a Week, Total 13 Times) Dose Toxicity/a 4-Week Recovery and TK Study.   These NOAEL data show that the ONX-1006 is very safe and would not cause ‘any’ harmful side effects when it is administered to humans. Essentially, a patient can carry out normal daily activities during the cancer treatment.  All the GLP test/study reports, as well as the protocols, are available upon request.

 

Five ONX-1006 xenograft studies were completed at Korean FDA certified test sites.  Both test sites, Dt&C and Chemon, reported statistically positive results, significantly reducing and suppressing the tumor size with ONX-1006.  AsPC-1 Pancreatic cancer cell and PANC-1 Pancreatic cancer cell lines were used for the xenograft tests. The impressive results are published on our company website.  Experts believe ONX-1006's groundbreaking non-toxicity and efficacy results should correlate with more than 95% in future human clinical trials. Pancreatic cancer is a difficult and insurmountable cancer (75% mortality rate in 1 year). Therefore, the company's ONX-1006 treatment will be a paradigm shift in anticancer treatment.

 

In the past 30 years, many companies (over 20+) attempted to develop such nanomedicine in Oncology. However, every company and drug candidate failed due to safety/toxicity, efficacy, and manufacturing problems. Nonetheless, ONX-1006 achieved groundbreaking milestone events and overcame those problems. ONX-1006 achieved these excellent efficacy and toxicological results in addition to mass nanoparticle manufacturing. We already produced 15kg of ONX-1006 in inventory (enough for 30,000 IV injections).

 

Recently we have completed all the necessary preclinical testing.  The company made tremendous progress, and we are about to embark on a groundbreaking journey to carry on the pancreatic cancer trial program. We will produce 300-400 vial bottles with saline 10 ml and ONX-1006 (PTX 100 mg) for Human clinical trials. 

 

The first Phase I/II trial will be a relatively short program due to the devastating aspect of the disease and its abysmal prognosis. A total of 8-24 Stage IV Pancreatic cancer patients will be administered ONX-1006 weekly dose for 3-12 months. 



Bong Soo Kim, Onselex +82-2-2138-2072 

info@onselex.com  

SOURCE Onselex Inc.  

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