HemaMax Therapies

Therapies under development for HemaMax™:

BLA Approval for Indications of Use Under Animal Rule CFR 601, subpart H:

Treatment of Hematopoietic Syndrome related to ARS as a result of exposure to Ionizing Radiation.

Follow on approval for other Indications of Use under a BLA are as follows:

Prevention of the hematological toxicity associated with cancer treatments, namely radiation and chemotherapy.  In this indication, it is anticipated that use of HemaMax will concomitantly provide anti-tumor effects over and above that of the primary therapy, in addition to preventing severe hematological toxicity generally caused by the cancer treatment. For this indication, HemaMax serves as a hematological adjuvant cancer therapy.

Treatment of the myelosuppression caused by cancer treatments, namely radiation and chemotherapy. 

For use in hematopoietic stem cell transplantation, currently used to treat lymphomas and leukemias.  It is anticipated that use of HemaMax along with a small number of HemaMax receptor positive hematopoietic stem cells can obviate the need for a conventional peripherally mobilized hematopoietic cellular transplant.

For use in the treatment of the bone marrow failure associated with aplastic anemia.

Current Profile

The preferred administration profile at the present time is SC. Other routes of administration such as IM and IP are under evaluation.

The anticipated dose for the product is 30 micrograms for a 70 kg person.

Generally it is expected that a single dose in humans will be sufficient to mitigate hematopoietic syndrome and increase survival.  The benefit of multiple dosing is under evaluation.