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October 1, 2013

Formula Pharmaceuticals announces the initiation of a pilot trial of FPI-01 in patients with Multiple Myeloma following autologous stem cell transplantation at Memorial Sloan Kettering Cancer Center.

Berwyn, PA – October 1, 2013 – Formula Pharmaceuticals Inc., an oncology-focused biopharmaceutical company developing novel therapeutics that target both cancer stem cells (CSCs) and various minimal residual disease settings, announced today the initiation of a pilot trial of FPI-01 in patients with Multiple Myeloma following autologous stem cell transplantation (ASCT) at Memorial Sloan Kettering Cancer Center (MSKCC).

Autologous stem cell transplant (ASCT) is a treatment for multiple myeloma in which some of a patient’s stem cells are removed before chemotherapy and returned to the patient to help re-establish the patient’s immune system after chemotherapy. However, in some patients, the myeloma returns quickly thereafter, or does not respond well to this treatment.

The purpose of this study is to evaluate a vaccine that targets the Wilms’ Tumor 1 (WT1) protein in patients with multiple myeloma who will be having ASCT. WT1 is a protein involved in normal development, but can fuel cancer growth when it is abnormal. In recent studies conducted at MSKCC, researchers found that the WT1 protein is overexpressed on myeloma cells. The WT1 vaccine will be given after the transplant in order to stimulate the patient’s immune system, with the objective to kill any remaining myeloma cells. Patients will also receive Montanide ISA 51 VG (a component of the vaccine) and GM-CSF (another drug) to help enhance the immune response.

MSKCC’s Principal Investigator of this phase-1 clinical trial is Dr. Guenther Koehne. Further information is available through http://clinicaltrials.gov and MSKCC’s website: http://www.mskcc.org/cancer-care/trial/12-288.

About Formula Pharmaceuticals

Formula Pharmaceuticals, Inc. is a privately-held, oncology drug development company advancing novel medicines to address areas of unmet therapeutic need in cancer. Formula’s lead product candidate, FPI-01, is a first-in-class immunotherapeutic in clinical development for the maintenance of first-remission in acute myeloid leukemia (AML) and other cancers. Building upon deep industry expertise in identifying, licensing and developing novel medical approaches, Formula's focus is on accelerating future life-saving cancer therapies.

Founded in late 2009 by Dr. Geerlings and Dr. Giorgio Mosconi, Formula has assembled a world-class scientific, clinical development and business team well positioned to maximize the clinical and commercial value of promising drug candidates through excellence in drug development and strategic partnering.
For more information, visit www.formulapharma.com.

Media Contact:
Mike Beyer
Sam Brown Inc.
(312) 961-2502
beyer@sambrown.com