In a clinical study, we observed a linear relationship between BriaVax TM exposure and the rising levels of CD40L (CD40 ligand) in a subject with a strong anti-tumor effect (please see the publication in the Clinical Trial section). CD40L is a protein that is expressed on components of the immune system including activated T cells, B cells, platelets, monocytic cells, natural killer (NK) cells, mast cells, and basophils. CD40L is known as one of the strongest stimulants of the immune system resulting in dendritic cell maturation, and rising serum levels of CD4+, CD8+, and NK cells, ., immune cells known for their anti-tumor activities. Additionally, the CD40/CD40L pathway is critical for the development of protective anti-tumor activity by providing a key initial step in the development of humoral (B cell/antibody-mediated) immunity. However, CD40L has also shown immune-suppressive activity in some tumor models. By higher expression of CD40/CD40L levels, tumors have been able to avoid both T cell and antigen-presenting cell (APC) compartments, and to establish an immunosuppressive tumor microenvironment.
Infusion-Related Reactions: Serious and sometimes life-threatening infusion-related reactions characterized by one or more of the following symptoms can occur with DOXIL ® : flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. The majority of infusion-related events occurred during the first infusion. Ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment is available for immediate use prior to initiation of DOXIL ® . Initiate DOXIL ® infusions at a rate of 1 mg/min and increase rate as tolerated. In the event of an infusion-related reaction, temporarily stop the drug until resolution then resume at a reduced infusion rate. Discontinue DOXIL ® infusion for serious or life-threatening infusion-related reactions.