Hemispherx Biopharma Inc (NYSE American:HEB) late on Monday revealed it has made considerable headway in advancing the development of its flagship cancer drug candidate Ampligen as it announced its financial results for 2018.
High on its list of achievements in 2018 was the signing of an agreement with Roswell Park Comprehensive Cancer Center in Buffalo, New York to evaluate Ampligen together with checkpoint inhibitors in the fight against bladder cancer, melanoma and renal cell carcinoma.
The Ocala, Florida drug maker also expanded its production to provide a supply of Ampligen for clinical and expanded access programs in the US, Canada, Europe and a commercial program in Argentina.
As of the close of 2018, two trials evaluating Ampligen were underway at a pair of major cancer research centers to test in humans whether Ampligen can be used to change the tumor microenvironment and increase the effectiveness of cancer immunotherapy like checkpoint blockade.
The first is a Phase 2A study treating patients with colorectal cancer that has spread to the liver at Roswell Park Comprehensive Cancer Center. The second is a Phase ½ study to test Ampligen as a combination therapy with chemo-immunotherapy for patients with recurrent ovarian cancer at the University of Pittsburgh Medical Center.
Looking ahead to other clinical trials in the US, Hemispherx is also working with the University of Pittsburgh Medical Center, Roswell Park's Comprehensive Cancer Center and the University of Nebraska Medical Center— to study Ampligen in pre-clinical and clinical studies for the treatment of nine cancer types: renal cell carcinoma, melanoma, non-small cell lung cancer, ovarian, breast, colorectal, urothelial, prostate and pancreatic cancer.
On top of this, the Florida company is also supplying Ampligen to an Expanded Access program in Europe at the Erasmus Medical Center in the Netherlands, which is treating pancreatic cancer patients with Ampligen.
Financial results in focus
The company’s research and development expenses in 2018 came to $4.78 million compared with $4.098 million in 2017.
In other news, its net loss from continuing operations amounted to $9.81 million, or $0.22 per share, against $8.259 million, or $0.29 per share, in 2017. The increase in the loss stemmed partly from manufacturing expenses for the 16,000 vials of Ampligen filled and finished in 2018.
As of December, Hemispherx had cash and cash equivalents of $1.825 million.
Hemispherx’s two key drugs are Ampligen, which fights both cancer and chronic fatigue syndrome, and the FDA-approved drug Alferon N Injection, a treatment for genital warts.
Hemispherx shares closed up 1.88% to finish at $0.16 on Monday.
Contact Ellen Kelleher at [email protected]