In July this year, Flagship Pioneering (FP) hatched package cell therapy Xinrui Sigilon Therapeutics Inc. (NASDAQ: SGTX) received the US FDA notification, suspended its patients with moderate or severe hemophilia for moderate or severe hemophilia Clinical trials of I / II.
The discontinuation of this test was due to a "a common treatment complication" in a patient. Prior to this, SIGILON has submitted a serious adverse event (SAE) report to the FDA and other regulators and suspend registration processes.
SIGILON launched in 2017 Robert Langer and Daniel Anderson laboratory in MIT. It is reported that SIGILON is listed in Nasdaque in December last year, and the market value is once more than 1 billion US dollars. At present, the company’s market value is only $ 122 million. And after the price of $ 18 in 18 US dollars, SIGILON is only slightly above $ 3.5 after the price of $ 48.
Robert Langer and MIT Daniel Anderson Laboratory research results based on Moderna Important Behind: SIGILON established the SIGILDED LIVING Therapeutics? (SLTX) technology platform, the engineering cell package is implanted into the patient. Its technical purpose is to protect the influence of the cells from the human immune system and prevent side effects. Therefore, some investors expressed concern for the test caused by complications due to complications.
Recently, SIGILON announced that after a patient in clinical study of only three people reported a serious adverse incident, the patient received laparoscopic surgery specified by the researcher to remove the implanted sphere. After inspection, it was determined that the sphere placed in the patient was already fibrilized, and the cells in the sphere no longer have vitality.
The patient accepted the highest dose in three individuals receiving the treatment, and there was a factor VIII antibody after the spherical implantation, which may be the cause of the patient to face uncontrolled bleeding risks.
Although the company surveyed the patient’s fibrotic sphere, all three patients participating in the SIG-001 test will continue to follow up in accordance with the research agreement. These findings may have an impact on the time of Patients in the I / II clinical trial of the SIG-005 I-type Polycharant Storage (MPS-1).
"Guaranteed patient safety is our primary task, we are collecting information to understand these observations," said Dr. Rogerio Vivaldi, President and CEO of Sigilon, "We will work closely with FDA, other regulators and company consultants to determine these Observation results on our project. "
Figure | Color scanning electron micrograph of blood clots (Source: The New York Times)
Hemophilia is a hereditary disease due to the lack of certain coagulation factors in the blood. The main manifestation of this disease is that it is difficult for blood and blood, and traditional therapy is long-term infusion condensation factor VIII.
Sigilon developed SIG-001 Hemophilia Type Tytopathic, by encapsulating cells that produce coagulation factor VIII into a semi-permeable protective film and implanted into a patient, while producing Caggered Factor VIII (FVIII) Free from an immune system attack and prevent scar tissue around it.
The SIGILON product line is mainly for three types of disease treatment: rare blood disease, lysosome disease and endocrine and other chronic diseases. It is to be explained that SIG-001 is the only major candidate drug that the company enters the clinical stage. If the test cannot be recovered, then SIGILON’s main push line will become two lysosomes that are currently undergoing clinical test. therapy.
Figure SIGILON R & D line (Source: SIGILON)
It is still unclear whether treatment has led to this adverse reaction incident, and the company spokesperson Brandon Hagen refused to express comments after the press release. SIGILON said in its published message, the results will be reviewed and evaluated in the SIG-001 Security Review Committee on next month.
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