2 Articles and News releases referenced by Asenio. One is from 1987 describing the promise offered by Dr. Carter and Ampligen along with the partnership with DuPont. The second describes the lawsuit with DuPont, with Dupont settling with HEM for 2.75 mil dollars (amazing) and DuPont giving HEM their stock back. The central claim of Dr. Carter in court was that DuPont screwed up by using plastic IV's compared to glass orignally used by Carter. I guess if this were true Ampligen would be a cure for AIDS. Sorry for the length of the post as the articles cam from a subscription service. I'm pissed at myself as I was following HEB on their run to 12 3/4 and was discouraged as when I did a subscription search on Ampligen I got 148 hits. I only looked at the recent ones which didn't discredit the company or the players. Damn missed a good opportunity
The Associated Press
June 5, 1987, Friday, PM cycle
SECTION: Domestic News
LENGTH: 487 words
HEADLINE: Researchers Say Drug Might Fight AIDS Infection
BYLINE: By MIKE OWEN, Associated Press Writer
DATELINE: PHILADELPHIA
BODY:
Researchers say they might have found a way to keep infection with the AIDS virus from developing into the deadly disease, but they caution more study is needed and questions remain unanswered.
The drug, Ampligen, showed in a pilot study that it could inhibit the virus and revive immune systems, researchers at Hahnemann University said Thursday at a news conference.
"We find no evidence to date that the AIDS virus escapes ... Ampligen," said Dr. William A. Carter, a co-developer of the drug and chairman of its manufacturer, HEM Research Inc. of Rockville, Md.
The key, researchers said, is the dual blow against the AIDS virus as well as a lack of side effects.
"It does both of the things you want an AIDS drug to do," said David H. Gillespie, one of the researchers involved in the pilot study.
About 70 percent of the patients with pre-AIDS condition are estimated to develop acquired immune deficiency syndrome within seven to 15 years after contracting the virus, the researchers said.
Ampligen, originally intended for cancer patients, is not available for widespread use, but if a new, six-month study gets good results, the drug could be approved for marketing by the end of the year, Carter said.
Researchers said the drug acts like a virus, stimulating the immune system to fight the AIDS virus. Carter said the drug works on handicapped immune systems "much like cardiac massage resuscitates a heart that is failing."
The pilot study, to be reported in the June 6 issue of the British medical journal Lancet, involved 10 patients: three with AIDS and seven with a pre-AIDS condition, either AIDS-related complex or lymphadenopathy syndrome.
Most of those who had not developed AIDS but were infected with the virus showed improvement during the seven- to 18-week study and still are doing well, the researchers said.
Among two of the three already suffering from AIDS, tumors decreased in size and patients regained energy, but the drug did not have permanent effect. One patient has died, and the other two are no longer on the drug.
The next step, researchers said, is a six-month study of 200 patients with pre-AIDS conditions at Hahnemann, George Washington University Medical Center in Washington and the Institute for Immunologic Disorders in Houston.
Half of the patients in the FDA-approved study will get placebos and half will get Ampligen, and neither patients nor researchers conducting the study will know who is getting which.
Among unresolved issues, researchers said, are whether the drug will wear off after continued use, whether it can hinder the infectiousness of the AIDS virus and whether someone can be weaned off it or expect always to need it, as in the case of diabetics requiring insulin injections.
Du Pont Co. of Wilmington, Del., has announced it bought a minority interest in HEM Research, and Carter said Du Pont could help expand the manufacturing.
Article #2
Copyright 1990 UMI Inc.;
Copyright Philadelphia Business Journal Inc. 1990;
Business Dateline;
Philadelphia Business Journal
July 23, 1990
SECTION: Vol 9; No 20; Sec 1; pg 11
LENGTH: 571 words
HEADLINE: Du Pont and Research Firm Settle Anti-AIDS Drug Suit
BYLINE: Michael W. Armstrong
DATELINE: Wilmington; DE; US
BODY:
E.I. du Pont de Nemours & Co. and HEM Research Inc. settled all litigation July 16 involving a failed joint venture between the two companies to develop an anti-AIDS drug, with the Wilmington-based chemical giant agreeing to pay HEM $ 2.75 million.
In addition, another lawsuit against HEM's chief scientist and founder, Dr. William A. Carter, was dropped by the plaintiff, Peter M. Frost.
Du Pont had provided HEM with funding and resources to conduct clinical trials of Ampligen on patients infected with human immunodeficiency virus (HIV) in 1988. But when preliminary results showed no difference between HEM's drug called Ampligen and a placebo, Du Pont said it was ending the joint venture. HEM halted the clinical trials in October 1988.
In April 1989, Du Pont filed suit in Delaware's Court of Chancery against HEM, which has offices in Tavernier, Fla., and Philadelphia, seeking more than $ 30 million. HEM countersued in U.S. District Court in Philadelphia.
Carter and other HEM officials were convinced the plastic packaging supplied by Du Pont had hurt the effectiveness of the Ampligen during the clinical trials. Prior to using plastic IV bags, HEM administered the drug from glass bottles.
"Everybody recognizes that . . . putting the product in plastic caused the trouble with the test," said E. Paul Charlap, HEM's chairman and chief executive officer.
A spokesman for Du Pont said the two companies had been negotiating toward a settlement for some time. Besides paying $ 2.75 million to HEM, Du Pont agreed to return 2.7 million shares of HEM stock to the private company and give up all of its rights to Ampligen.
HEM valued the total settlement at "substantially more" than $ 5 million.
Charlap, who was the co-founder of Savin Corp., said HEM has undergone a "remarkable turnaround" since he and a group of investors invested a reported $ 1.5 million in HEM in May 1989. "We heard (Ampligen) was nothing, and the company . . . was dead," he said. "Here we are again."
HEM has been talking with the Food and Drug Administration about granting new clinical trials for Ampligen for the treatment of HIV, Charlap said. The company is currently conducting clinical trials in the United States for the treatment of patients with chronic hepatitis B infection, cylomegalovirus and chronic fatigue syndrome.
The company has also obtained approval from Ireland's Ministry of Health to start investigative clinical trials of Ampligen to treat both pediatric and adult patients with AIDS-related immune disorders.
Neither Du Pont nor HEM has soured on future corporate partnerships. An arrangement with a larger drug company "absolutely is a necessity for us," Charlap said. "We don't have the ego to believe we can do what a major pharmaceutical company can."
Charlap would not speculate when HEM might sign an agreement with another drug company. "We have pushed away people," he said. "We've been too busy doing the science."
In the resolution of another piece of litigation, the suit filed against Carter in federal court in Philadelphia in May 1989 by Frost was dismissed at Frost's request. Frost, who lives in Houston, is infected with HIV. He had sued alleging securities fraud. No payment of any kind was made by Carter to Frost in connection with the dismissal.
HEM now employs about 50 people in Philadelphia and Florida and at its research-and-development center in Rockville, Md.
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