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Hemispherx Biopharma’s well-funded to take promising cancer drug Ampligen through clinical trials

CEO Thomas K Equels says it’s time for the company to seek out big pharma partners who share its 'excitement and enthusiasm' for Ampligen’s potential

A patient screening for breast cancer
The Orlando, Florida-based biotech is studying Ampligen to treat multiple cancers including breast and ovarian cancers

Hemispherx Biopharma Inc (NYSEAMERICAN:HEB) revealed Thursday that it has boosted its cash pile impressively through May to shoulder a series of trials evaluating the company's promising cancer drug Ampligen at major cancer research hospitals.

The Orlando, Florida-based biotech said stockholders participated in a rights offering to raise $5.3 million. Therefore, as of March 31, Hemispherx had cash and cash equivalents of $4.9 million, compared with $1.8 million as of December 31, 2018.

READ: Hemispherx Biopharma says FDA authorizes study using aspirin and flagship drug ampligen to treat prostate cancer

"When our management team began three years ago, Hemispherx identified four significant steps we needed to take to make our company a success,” said Hemispherx CEO Thomas K Equels. “First, raise the funds necessary to produce our drug candidate, Ampligen, for use in immuno-oncology clinical trials and other programs. Second, produce adequate supplies of Ampligen to conduct such trials. Third, initiate multiple immuno-oncology clinical trials. We have now accomplished each of these steps and are using Ampligen to treat cancers in clinical trials.”

Seeking big pharma partnerships

Equels says “now is the time” for the company to seek out big pharma partners who share the company’s “excitement and enthusiasm” for the potential of Ampligen.

“We believe that success in these trials will create the environment for that goal,” said Equels. “Accomplishing success in R&D is based on such progress."

Hemispherx recently announced significant progress in multiple Ampligen-plus-checkpoint-blockade immuno-oncology programs.

Multiple trials underway

It has been a busy spell for the company with the following trials underway:

  • Initiated a 45-patient clinical study in ovarian cancer at University of Pittsburgh Medical Center combining Ampligen, cisplatin and pembrolizumab, data expected by 2021.
  • Initiated a 12-patient clinical study in colorectal cancer at Roswell Park Comprehensive Cancer Center combining Ampligen, Intron A, and celecoxib, data expected by 2020.
  • Initiated a six-patient clinical study in triple negative breast cancer at Roswell Park Comprehensive Cancer Center combining with Ampligen, Intron A, celecoxib and pembrolizumab, data expected by 2020.
  • Extended the Early Access Program (EAP) at the Erasmus Medical Center in the Netherlands using Ampligen in the treatment of patients with pancreatic cancer. The EAP is approved by the Dutch Health Inspectorate until March 9, 2020 to treat pancreatic cancer patients diagnosed with any stage of the serious disease. Patients receive Ampligen as a maintenance therapy after completing standard care. 
  • An additional round of comprehensive pre-clinical animal pancreatic cancer studies were initiated at the University of Nebraska to reconfirm the successful results seen in the initial animal studies.
  • Received an interim report on a recurrent Ovarian Cancer Phase 1/2 study of intraperitoneal chemo-immunotherapy at University of Pittsburgh Medical Center.
  • The Phase 2 study of neoadjuvant conditioning of prostate cancer using Ampligen as a component of chemokine modulation at Roswell Park Comprehensive Cancer Center has received authorization to proceed by the FDA.

Research and development manufacturing-related expenses for the first quarter were $0.93 million, an 8% increase compared with $0.86 million for the first quarter of 2018. The increase was due to Ampligen related stability testing and maintenance.

The net loss from continuing operations for the first quarter was $3.36 million, or $0.07 per share, compared with $2.71 million, or $0.07 per share, for the same period a year ago.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive

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