OCALA, Fla., Aug. 02, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE American: HEB) recently demanded and received retractions and corrections in two cases of inaccurate reporting due to AI algorithms following the filing of an 8-K on July 22, 2019. The two stock news organizations, Sagient Research and StreetAccount, both misreported that the company was raising $70 million in an Equity Distribution Agreement when, actually, the company was simply renewing a prior EDA that was related to an ATM and making the requisite SEC filings to raise up to $4.5 million under the new EDA, the maximum permitted at this time. In fact, the ATM has not even been used in six months.
These two organizations, which have no relationship with Hemispherx, promptly delivered the corrections to their subscribers, as follows:
- Sagient Research — “Correction to Previous CustomWatch from July 23rd, 2019. This CustomWatch is not a new transaction. PlacementTracker previously recorded the transaction as $70,000,000 Commitment Amount. That amount is $4,508,244.”
- StreetAccount — “On 22-Jul we posted a comment which noted that Hemispherx Biopharma entered in new equity distribution with Maxim for up to $70M, but we did not include that the prospectus supplement had an aggregate offering price of up to $4.5M … We have corrected the original comment to reflect the correct aggregate offering price of up to $4.5M, not $70M … We apologize for the error [Emphasis added].”
“The value we are building at Hemispherx Biopharma is based upon five ongoing clinical trials, and it’s unfortunate that these computer-driven reports mischaracterized our SEC filings and possibly affected the trading in our common stock,” said CEO Thomas K. Equels. “We are seeing steady and significant progress in the five trials studying our drug Ampligen, especially in combination with pembrolizumab in the field of immuno-oncology.”
Ampligen is currently being evaluated in five investigator-sponsored clinical trials, as follows:
- Recurrent Ovarian Cancer — A 45-patient, Phase 2 clinical trial combining Ampligen, cisplatin and pembrolizumab. This trial is being conducted at the University of Pittsburgh Medical Center by Dr. R. Edwards. The first patient was treated on June 11, 2019 and treatment of patients is underway. See ClinicalTrials.gov.
- Colorectal Cancer Metastatic to the Liver — A 12-patient, Phase 2a clinical trial combining Ampligen, Intron A and celecoxib. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. P. Boland. To date, seven subjects have been enrolled and completed treatment, and the trial is progressing well. Data from this trial is expected in 2020. See ClinicalTrials.gov.
- Metastatic Triple-Negative Breast Cancer — A 6-patient, open-label clinical trial combining Ampligen, Intron A, celecoxib and pembrolizumab. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. M. Opyrchal. Patients have been enrolled and are in early treatment. See ClinicalTrials.gov.
- Recurrent Ovarian Cancer — A Phase 1/2 clinical trial of intraperitoneal chemo-immunotherapy in recurrent ovarian cancer. This trial is being conducted at the University of Pittsburgh Medical Center by Dr. R. Edwards. Eleven patients in the Phase 1 portion have been enrolled; 10 have completed treatment and one is undergoing treatment and evaluation. An interim report from Dr. Edwards' team was received and they are drafting a manuscript on the biological and clinical outcomes from the Phase 1 portion of the trial. See ClinicalTrials.gov.
- Prostate Cancer — A 60-patient, Phase 2 randomized, three-arm clinical trial of aspirin and Ampligen with or without Intron A compared with no drug treatment in patients with prostate cancer before undergoing radical prostatectomy. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. G. Chatta. IRB and FDA approval have been received. Roswell expects first enrollment in the immediate future. See ClinicalTrials.gov.
In addition, Hemispherx has an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands for pancreatic cancer at Erasmus Medical Center that has been ongoing for two years. The team at Erasmus is making progress under the supervision of Prof. Casper van Eijck, MD, a world-renowned specialist in this dreaded malignancy, and Diba Latifi, MD. The Dutch government has approved and extended the therapeutic program for an additional year. Early progress was reported in a published abstract from Erasmus. The abstract was part of a larger original report covering a variety of medical topics, which can be found here. The last patients to be enrolled prior to a planned paper are nearing the end of treatment. The company believes that the survival data to date has been very positive, and the paper is expected in 2020.
Hemispherx also has an Expanded Access Program for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States and an Early Access Program for ME/CFS in Europe. Hemispherx is conducting AMP-511, wherein the FDA has authorized compassionate care for up to 100 subjects. Further, Hemispherx is preparing a manuscript for publication clearly identifying a subset with a high response rate to Ampligen. See: ClinicalTrials.gov.
Go here for Hemispherx’s current corporate update.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, Hemispherx believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. These and other potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. Among other things, no assurance can be given as to whether the ongoing or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities of the Cancer Centers sponsoring these trials. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.