Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Biological Products

(Cell therapy products) JW CreaGene Corporation
  • Registration Date 2017-03-09
  • Hit 3763

Company Information

1. Name

JW CreaGene Corporation

2. Website Address

www.creagene.com

3. Location

2F, Jungang Induspia V,137, Sagimakgol-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea, 13202

4. Contacts

Tel: +82-31-737-3300

Fax: +82-31-737-3301

Pharmaceutical Product Information

1. Brand Name

CreaVax-RCC®

2. Active Ingredient

Autologous Dendritic Cells

3. Indication

Metastatic Renal Cell Carcinoma

4. Information

CreaVax-RCC® , autologous dendritic cell based cancer vaccine, produced from patient’s peripheral blood mononuclear cells (PBMC) by differentiating into dendritic cells after sensitizing with tumor lysate and KLH(Keyhole Limpet Hemocyanin). Once CreaVax-RCC® are injected, the equipped DCs move to the regional lymph nodes to modulate immune response such as induction of cancer-specific cytotoxic T lymphocytes (CTL) to kill tumor cells. CreaVax-RCC® have received tentative approval (2007) and product manufacture license as export product (2013) from MFDS.

[Application]

5x107 cells (1 vial of CreaVax-RCC Inj.) are to be administered 4 times at the interval of once every 2 weeks (The duration of administration may be adjusted in accordance with the decision of the physician)

[Publication]

1. Phase I/II Study of immunotherapy using autologous tumor lysate-pulsed dendritic cells patients with metastatic renal cell carcinoma. Clin. Cancer Immunol. 125:257-67, 2007

5. Images

Attached File

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