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KDDF-201410-10 The development of a global new oral drug to treat Chemotherapy Induced Neutropenia(CIN)(Hematological Diseases, Chemical) [03.04.2015]

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Development and Market Objectives

• Neutropenia is a common dose-limiting toxicity during the treatment with myelosuppressive cancer drugs. Chemotherapy-induced neutropenia (CIN) often leads to a dosing delay and/or reduction of dose resulting in the compromised chemotherapy. The current standard of care is a parental product (G-CSF), and it suffers from various side effects and limited use only in febrile neutropenia. Our goal is to develop an orally efficacious drug that can be generally applicable to both febrile and afebrile neutropenia with an excellent safety profile.

Unmet Medical Need & Target Patients

• A recent review reported that 16.8% out of 2,131 patients who received various chemotherapies experienced febrile CIN (J Oncol Pharm Pract 20 (3): 190, 2014). Another review reported that 10.7% out of 2,692 cancer patients experienced febrile CIN, and 29.3% experienced Grade 3-4 CIN (febrile and afebrile combined). (J Natl Compr Canc Netw. 6:109, 2008.)

• In the clinic, G-CSF injection is the standard of care to increase the numbers of neutrophils and to prevent infection. However, G-CSF products are expensive, inconvenient to use, indicated to only febrile neutropenia, and problematic due to several side effects/toxicities such as pain, fever, rash and splenic rupture, etc. Therefore, a new therapeutic agent that can overcome the various issues of current therapy, G-CSF, in terms of convenience, target patients, cost and safety is warranted.

Status

• The core battery of safety studies testing up to the maximum doses of 2000 mg/kg in the nonclinical animals did not raise any safety concern. A variety of nonclinical studies and Phase 2a study demonstrated the efficacy of EC-18 after oral administration. The mechanism of actions of EC-18 shows attenuation of chemotherapy-induced neutrophil extravasation from blood vessels. Phase 1 clinical study was successfully finished in US and Korea. Currently, phase 2 clinical trial is under preparation. In addition, various investigations including formulation optimization, absorption mechanism, DMPK, and toxicity are ongoing.

Intellectual Property

• Method for treating, controlling or mitigating neutropenia comprising administration of a monoacetyldiacylglycerol
• Methods for treating, controlling or mitigating neutropenia and other conditions, comprising 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 chemotherapeutic agents, such as lenalidomide and monoacetyldiacylglycerol

Competitive Advantages

Patient population: G-CSF is mostly indicated for febrile neutropenia whereas EC-18 can be used in both febrile and afebrile neutropenia (Grade 3-4). 

 

Route of administration: G-CSF is administered parentally whereas EC-18 is an oral drug.

 

Superior efficacy: G-CSF cannot be administered until 24 hours after the completion of chemotherapy whereas, EC-18 can be administered prior to the initiation of chemotherapy to effectively prevent neutropenia. 

 

Safety: Common side effects of G-CSF include pain, fever, rash and splenic rupture, whereas those were not found in EC-18 so far. 
 

Indication

Neutropenia

Research Period

Feb, 2015 ~ Sep, 2016

Company

Enzychem Lifesciences

Developmental Stage

Clinical phase 1

Additional Information

Contact Information

Contact
Address Company Name: Enzychem Lifesciences Corporation
WebSite Homepage: http://www.enzychem.com Contact Person: Yong-Hae Han, Ph.D., President/CTO
E-mail: yonghae.han@enzychem.com Contact: +82-2-6213-7105

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