SBI Pharmaceuticals Co., Ltd., (Head office: Minato-ku, Tokyo; Representative Director & President: Yoshitaka Kitao), a subsidiary of SBI Holdings, Inc., engaged in the research and development of pharmaceuticals and medical devices regarding 5-aminolevulinic acid (5-ALA) (*), announces that it has initiated a Phase III clinical study (ASTROPIC study; jRCT2021250012) and successfully enrolled the first patient.
Overview of the ASTROPIC study
| Item | Description |
| Objective | To evaluate the efficacy and safety of photodynamic diagnosis (PDD) using ALAGLIO® Oral 1.5g (5-ALA Hydrochloride) during tumor debulking surgery in patients with ovarian, fallopian tube, and peritoneal cancer. |
| Design | Multicenter, open-label trial |
| Primary Endpoint | Sensitivity of biopsy specimens under PDD and conventional observations |
The development of ALAGLIO® for ovarian cancer is being advanced in collaboration with Nippon Kayaku Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President: Shigeyuki Kawamura), the authorized distributor.
PDD using 5-ALA enables the detection of tumor lesions that are difficult to identify with conventional visual methods. By applying PDD during surgery for patients with ovarian cancer and related conditions, it is expected to enhance the completeness of tumor resection.
SBI Pharmaceuticals remains committed to advancing research and development to support healthier and more fulfilling lives. The company continues to strive to make ALAGLIO® a valuable tool for both patients and healthcare professionals involved in the treatment of ovarian cancer.
* 5-ALA is an amino acid produced in the mitochondria of the body. When taken up by cancer cells, its major metabolite, protoporphyrin IX, accumulates. Upon exposure to excitation light, protoporphyrin IX emits fluorescence from the cancer cells. This property has led to the practical use of 5-ALA hydrochloride as an intraoperative diagnostic agent for non-muscle invasive bladder cancer and malignant glioma.
About Ovarian Cancer:
Ovarian cancer ranks as the 9th most common cancer among women in Japan and is reported to be the leading cause of death among malignant tumors of the female reproductive system. Improving treatment outcomes for advanced cases remains a critical challenge. Complete tumor resection through surgery is considered one of the most important prognostic factors in the treatment of advanced ovarian cancer.
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For further information:
SBI Pharmaceuticals Co., Ltd.
E-mail: info_ala@sbigroup.co.jp
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