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KDDF-201606-08 Global Phase 2 clinical development of a first-in-class, new oral drug for the treatment of Chemotherapy Induced Neutropenia(Hematological Diseases, Chemical) [2019-07-29]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

This study is to aim at global Phase II clinical development of EC-18 in the treatment of CIN, which then pursues its development as a first-in-class oral drug since the efficacy, safety and tolerability of EC-18 were proved throughout both nonclinical studies and Phase I clinical trials in Korea and US.  
 

Unmet Medical Need & Target Patients

Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses of the chemotherapy that can be tolerated.
- Weycker D et al. reported that among the 2,131 patients who received myelosuppressive chemotherapy, those who experienced febrile neutropenia (FN) episodes accounted for 16.8% (Weycker D et al. J Oncol Pharm Pract 2014 20(3):190-8)
- Crawford et al. reported that among 2962 cancer patients who received chemotherapy treatment, those who experienced severe neutropenia episodes including FN and Grade 3/4 neutropenia were 29.3% (Crawford J et al. J Natl Compr Canc Netw 2008 6(2):109-18) 

 

Limitations of the use of recombinant human granulocyte colony stimulating factor (G-CSF) in treatment of neutropenia
- Use of G-CSF is restricted in afebrile neutropenia episodes although it is preferably indicated to febrile neutropenia.
- G-CSF is recommended to administer via daily subcutaneous injection, producing inconvenience and high cost.
- Use of G-CSF has been concerned due to its AEs including chronic pain, fever, skin rash, and the enlargement and rupture of spleen and avoided in patients with certain conditions such as bone marrow malignancy

 

Taken together, safer and more efficacious drugs for neutropenia are demanded. EC-18 distinct from G-CSF in mechanism could be a first-in-class drug with great advantages of safety and efficacy. Moreover, its oral application could be a plus.

Status

Preclinical proof of principle and concepts of EC-18 in the treatment of CIN were studied in vitro and in vivo, summarized as follows:


- The mechanism of action of EC-18 shows attenuation of chemotherapy-induced neutrophil extravasation from blood vessels.
- The co-administration of anti-cancer drugs and EC-18 resulted in reduction of neutropenia in rodents.
- The efficacy of EC-18 on CIN in humans was demonstrated in a pilot study, which showed that the combination therapy of chemotherapeutic agents and EC-18 alleviated neutropenia in patents with pancreatic cancers as compared to placebo.
- In the core battery of nonclinical safety studies, EC-18 2000 mg/kg was observed with no test drug-related toxic events and safety concerns.

 

The Phase 1 clinical trials of EC-18 with health volunteers were successfully completed in Korea and US.
Currently, the Phase 2 clinical trials of EC-18 initiate in Korea and US.
In addition, investigations of formulation optimization, absorption mechanism, DMPK and advanced toxicological studies have been performed in parallel.

Intellectual Property

Total 17 patent registrations/applications are briefly represented as follows:


- Methods for treating, controlling or mitigating neutropenia by monotherapy and other conditions that include administration of a monoacetyldiacylglycerol simultaneously, sequentially or in combination with a granulocyte colony stimulating factor (G-CSF)
- Methods for treating, controlling or mitigating neutropenia and/or thrombocytopenia, in patients receiving a chemotherapeutic agents, lenalidomide and monoacetyldiacylglycerol
 

Competitive Advantages

EC-18 can be used in both febrile and Grade 3/4 afebrile neutropenia while G-CSF is mostly indicated for febrile neutropenia.
EC-18 can be administered prior to the initiation of chemotherapy in order to effectively prevent neutropenia whereas an injection of G-CSF is only given after 24 h post-chemotherapy.
Common side effects and AEs of GCSF include pain, fever, skin rash and spleen enlargement or rupture whereas those have not been yet found with EC-18.     
 

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