Hemispherx Biopharma (NYSEAMERICAN: HEB) issued a press release this morning, announcing overwhelmingly positive results from a Phase 1 study. In the study, the company is assessing Ampligen as a potential option for patients with ovarian cancer. Here’s what’s going on:
HEB Stock Is Worth A Look After This Data
In a press release issued early this morning, Hemispherx Biopharma announced that the University of Pittsburgh Medical Center, or UPMC, has issued a final report with regard to the safety of using Ampligen. In particular, the report surrounded the use of Ampligen in combination therapy for the treatment of recurrent ovarian cancer.
The data came from a Phase 1 clinical trial under which patients received cisplatin and Ampligen with Intron A and celecoxib. Leading the charge in the study were Drs. Robert Edwards, Anda Vlad and Brian Orr.
According to their report, HEB said that Ampligen proved to be well tolerated on an intraperitoneal basis and as a combination therapy.
Importantly, the positive Phase 1 results led to the initiation of a Phase 2 clinical study in ovarian cancer at UPMC. In the Phase 2 trial, stage 4 ovarian cancer patients will be treated with a combination of Ampligen, cisplatin and pembrolizumab.
The study is planned to enroll 45 patients and is designed to assess the combinational synergy with checkpoint blockade therapy where Ampligen is administered by injection into the peritoneal cavity where the tumor is located. More information on the trial is available here.
In a statement, Thomas K. Equels, CEO at HEB, had the following to offer:
The positive results regarding the safety and survival using Ampligen, as evidenced in these first stage 4 patients treated in the Phase 1 study, are extremely encouraging in our quest to expand horizons in immuno-oncology, facilitating a path toward greater efficacy for checkpoint blockade therapies.
The results are consistent with foundational research Hemispherx obtained in animals, as well as in clinical trials in humans with melanoma and renal cell carcinoma, where Hemispherx Chief Medical Officer Dr. David Strayer was the Principal Investigator, that support the impact Ampligen has in making the tumor more susceptible to host immunosurveillance and more susceptible to destruction by a host immune response in the presence or absence of additional immune or chemotherapeutic agents.
Dr. Orr wrote the following in the Phase 1 report:
This concludes that these drugs can be given in this combination with no major toxicities noted and no evidence of added toxicity when adding the immunomodulators to cisplatin as most of the grade 3 toxicities listed above are common with cisplatin.
Dr. Edwards wrote:
The Phase 1 study, in addition to generating excellent safety data, has also produced positive survival data with regard to the stage 4 ovarian cancer patients participating in the recently completed recurrent Ovarian Cancer Phase 1 Study.
This News Is Significant
The positive data released this morning is a significant step in the right direction. After all, it is crucial evidence that will lead to further study of the drug and more importantly, assist in the potential approval of the Ampligen in oncology indications down the road.
It’s important to keep in mind that oncology indications will give HEB access to a massive market opportunity. While Ampligen is being assessed across a wide array of cancer types, even in just the ovarian cancer indication, Grand View Research expects for the market to grow to be worth around four and a half billion dollars annually by the year 2022.
Think about it, we’re talking about a company with a market cap of around $5 million. Even capturing a small percentage of a $4.5 billion market opportunity would be a substantial increase in value for HEB and its investors. The bottom line here is that the news takes Hemispherx Biopharma one step further down the path of developing what could prove to be a blockbuster treatment option.
The Bottom Line
The bottom line here is that HEB is onto something big here with Ampligen. The company became the first company to earn approval for the ME/CFS indication globally when it received regulatory approval to market the drug in Argentina. Now, Hemispherx is working on larger opportunities in a much larger market, and doing so with great success. All in all, this is a compelling story that could prove to be overwhelmingly valuable in the long run!
Don’t Miss The Next Big Story!
Join our mailing list below to receive free updates!
CNA Finance, parent company to Alpha Stock News, has a monetary relationship with Hemispherx BioPharma.