BRAIN TUMORS
GRANTS / FUNDING
Funding for Phase 1 & 2
In February 2019, a $6 million-dollar grant for the development of Berubicin from the National Centre for Research and Development in Poland was awarded for the continued development of Berubicin in adult and in pediatric population. Previous grants and development costs are estimated to be more than $15 million focused on developing Berubicin.
REGULATORY
Berubicin has previously received an Orphan Drug designation in the US, which provides seven years of marketing exclusivity.
DRUG DISCOVERY & DEVELOPMENT
Additional Indications
Reata Pharmaceutical (Nasdaq: RETA)
$3 Billion- dollar Nasdaq listed company, drug development - conducted Phase I clinical trials.
Houston Pharmaceuticals
Drug development
MD Anderson
Leading cancer research center in the world, drug discovery.
CNS Pharmaceuticals, Inc.
Drug development
WPD Pharmaceuticals
Co-development partner
CLINICAL DEVELOPMENT
Phase 1
Berubicin’s Phase I clinical trial conducted in 2009, the first time it was tested in humans, yielded very promising results with 44% of the patients showing a clinical response. In addition, Berubicin has shown evidence of improved overall survival in a patient population that currently has a dismal median survival rate of only 14.6 months from diagnosis. Berubicin is expected to begin Phase II clinical trials in the 2nd half of 2019.
INDICATIONS
Subsequent Studies
GBM.
OTHER INDICATIONS
Additional Indications
Berubicin may be developed to treat additional diseases, including pancreatic and ovarian cancers and lymphoma. Additionally, combination therapies that include Berubicin may be researched.