BioSenic focuses on two therapeutic areas: control of innate immunity and tissue repair, for a return to normal function. Their common challenge: the control of inflammation.
In the field of immunity, BioSenic owns, through its subsidiary Medsenic, Arscimed® : an innovative drug to treat autoimmune diseases at the source of the immune cascade. Arscimed® is proposed for three applications: a treatment used in Phase II for cGVHD (Chronic Graft versus Host Disease), an application for Systemic Lupus Erythematosus, and another for Systemic Sclerosis. Today, a Phase III in cGvHD is being prepared with an oral treatment: ArsciCor
BioSenic has also developed an innovative allogeneic product, ALLOB, which currently targets a bone indication and offers the possibility of extending the product portfolio to other bone defects.
ArsciMed® is an innovative intravenous drug to treat autoimmune diseases at the source of the immune cascade. Arscimed® is proposed for three applications: a treatment used in Phase II for cGVHD, an application in Systemic Lupus Erythematosus, and another in Systemic Sclerosis. Today, a Phase III trial in cGVHD is being prepared with an oral treatment: ArsciCor.
Arsenic trioxide GMP obtained by de novo synthesis from the basic chemical elements has been included in a formulation that can be administered orally. This formulation is original and protected by international patents and an exclusive license and extended marketing rights for in particular the indication Chronic Graft versus Host Disease, which is BioSenic's main pathological target. The particular advantage of this formulation is its oral use, a major benefit for clinicians and patients. This formulation has the characteristics of rapid gastrointestinal solubilization, optimal bioavailability comparable to the intravenous formulation, and bioequivalence that has recently been proven in a very rare condition, acute promyelocytic leukemia.
cGvHD - Chronic Graft versus Host Disease - is a complex autoimmune reaction that develops following bone marrow transplants or more precisely allogeneic hematopoietic stem cells, with a frequency of 30-60%. It affects about 16,000 people in the European Union and 20,000 in the United States and Canada, which places it under the name of Orphan Disease.
After transplantation, the immunocompetent cells contained in the graft often trigger an immune reaction against the recipient - the so-called "host". They consider the recipient's own antigens as foreign and try to destroy them. The donor's T-cells thus attack the recipient's tissues and organs. This phenomenon is observed even between donors and recipients who are immunologically very close and remains a major obstacle to therapeutic transplants in hemato-oncology.
Acute cGvHD occurs in the weeks following transplantation. After a certain period of time, the reaction changes in nature and presents characteristics of an autoimmune disease. It becomes chronic, with a worsening that is often uncontrolled by conventional immunosuppressive treatments, with a poor prognosis, making cGvHD potentially fatal. Hence the urgent need for new therapeutic approaches.
After a positive Phase II study, BioSenic is finalizing the preparation of a Phase III randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral arsenic trioxide (OATO) as a first-line treatment. The oral formulation, known as OATO - or ArsciCor for autoimmune applications - has the characteristics of rapid gastrointestinal solubilization, optimal bioavailability comparable to the intravenous formulation, and a high level of safety.
A positive FDA PreIND has been issued to initiate a Phase III clinical trial in this disease.
BioSenic is also conducting preclinical research on several lines:
- a next generation of regenerative products, including products composed of combined cell matrices for major bone defects and maxillofacial applications.
- an innovative formulation based on Arsenic Trioxide - ArsciCop - to be developed in several other rare autoimmune diseases
Warning: ATO and OATO are products under study and are not yet available for sale. This website is not intended to provide medical advice or to be a substitute for professional medical care. Consult a physician or medical provider for information about your diagnosis or situation
ALLOB is an allogeneic differentiated osteoblast product with regenerative properties for the treatment of bone diseases. It is derived from bone marrow stem cells grown ex vivo. The term "allogeneic" means that the cells are taken from a healthy donor, as opposed to the "autologous" approach in which the cells are taken from the patient. ALLOB is currently in two Phase I/IIA proof-of-concept trials for the treatment of delayed healing fractures and spinal fusion procedures.
ALLOB received orphan drug designation for osteonecrosis from the EMA in July 2013 and from the FDA in January 2014. The product also received orphan drug designation from the EMEA and the FDA for osteogenesis imperfecta (glass bone disease). ALLOB has been classified as a tissue-engineered product (not combined) by the EMEA under the ATMP 1394/2007EC regulation.
Warning: ALLOB is a product under study and is not yet available for sale. This website is not intended to provide medical advice or to be a substitute for professional medical care. Consult a physician or medical provider for information regarding your diagnosis or situation.
Indication for bone cell therapy products.
BioSenic's bone cell therapy products are currently in clinical trials for one indication.
A delayed healing fracture is defined as a fracture that has not healed within a period of time considered normal after the initial fracture (i.e., 3 to 4 months) and is at risk of not healing. Traditional treatments for a severe nonunion fracture (i.e. bone grafting) involve extensive surgery and the risk of severe complications. Because of these risks, orthopedic surgeons often take a wait-and-see approach to treating delayed healing fractures, sometimes for several months, which delays the patient's return to a normal life and generates high socio-economic costs.
ALLOB has the potential to become a first-line treatment for delayed healing fractures thanks to its minimally invasive administration, which avoids the need for major surgery.