Replies to post #15431 on Marker Therapeutics Inc (MRKR)

[lasers]

$TPIV Clinical Trial NCT02593227

https://clinicaltrials.gov/ct2/show/study/NCT02593227#contacts

Detailed Description:

Triple negative breast cancers (TNBCs) occur in approximately 20-25% of all patients with breast cancer and are associated with a poor prognosis. Patients with TNBCs derive no benefit from targeted therapies. Excluding those patients who demonstrate a pathologic complete response following neoadjuvant chemotherapy, which is a minor fraction (i.e. 15%), overall survival is only 45% at 7 years.

Following standard of care, there are windows of opportunity to further and safely treat patients to prevent recurrence. Stimulating the immune system to produce T cells immunity specific for tumor antigens may significantly delay recurrence and cure patients.

The proposed vaccine is intended to induce T cells to survey for the reemergence of TNBCs and to prevent recurrence in the adjuvant setting. The vaccine strategy is antigen-specific and targets the Folate Receptor Alpha (FRa). FRa is an ideal target because of its limited expression in the healthy tissues and it high expression in 86% of TNBCs. Studies have shown that it is a biologically important marker that is associated with poorer clinical outcome and is retained in metastatic lesions.

The FRa vaccine include a pool of 5 peptides that are immunogenic epitopes and safely generate tissue-surveying CD4 T cell immune responses in patients tested in a recently completed phase I clinical trial.

[apostrophe]

re:"$TPIV 80 person study will be to compare TPIV200 vs Chemotherapy Drug: Cyclophosphamide "

cyclophosphamide, Cytoxan (cont.)

SIDE EFFECTS: Side effects of cyclophosphamide include:
hair loss, vomiting, diarrhea, mouth sores, weight loss, sterility, and jaundice.

Cyclophosphamide causes kidney failure, and it also may affect the heart and lungs. Cyclophosphamide suppresses production of blood cells from the bone marrow, including white blood cells (leukopenia), red blood cells (anemia) and platelets (thrombocytopenia). Leukopenia reduces the ability of the body to fight infection, thrombocytopenia impairs the ability of blood to clot, and anemia reduces the ability of blood to carry oxygen. Cyclophosphamide suppresses the immune system which may result in serious and sometimes fatal infections. Severe allergic reactions also may occur. Cyclophosphamide may cause inflammation of the urinary bladder with bleeding (hemorrhagic cystitis). This can result in lower abdominal pain from the bladder, problems urinating due to blood clots, and anemia due to loss of blood. "

http://www.medicinenet.com/cyclophosphamide/page2.htm

[Rkmatters]

That isn't exactly accurate. You may want to look at the arms again. All patients will be on TPIV200; either low or high dosage. It isn't to compare itself to the chemo drug. Instead it is meant to compare whether the vaccine low or high dosage works better or worse with or without the chemo drug. Patients in the last trial were on this same chemo drug. It will be interesting to see if patients even need to be on chemotherapy. This study will test that.