DiffGAM
ImmuCell Announces Positive Preliminary Results From Clinical Trial of DiffGAM
PORTLAND, Maine--(BW HealthWire)--March 28, 2000--ImmuCell Corporation (NASDAQ:ICCC) today announced positive preliminary results from its clinical trial of DiffGAM bovine anti-Clostridium difficile immunoglobulins in the treatment of Clostridium difficile associated diarrhea ("CDAD"). In this multi-center, open label, Phase I/II study, the prospective statistical endpoint for success was met, resulting in early termination in the `Primary CDAD' arm of the study (i.e. patients with their first diagnosed CDAD episode). Ten of 12 evaluable patients met the clinical endpoint of diarrhea reduction during the treatment phase of the study. In addition, the milk immunoglobulin product was well tolerated.
In the `Relapse' arm of the study (i.e. patients with at least one previously diagnosed and treated episode of CDAD), 7 patients have been enrolled to date. Subject to the availability of funding, this arm of the study will continue to enroll patients until 22 evaluable patients have been enrolled or the prospective statistical endpoint is reached.
The current study evaluated DiffGAM as a stand-alone therapy rather than as an adjunct to the current treatment standard (antibiotics such as metronidazole or vancomycin). The Company believes that by providing an effective alternative to antibiotic therapy, the chance of relapse could be reduced. It is widely believed that the overuse of broad spectrum antibiotics can lead to the development of antibiotic-resistant organisms. CDAD effects over 1 million individuals per year in the United States.
"We believe that this product could provide an important benefit to patients by arming doctors with an effective alternative to antibiotics in the care of this debilitating disease," commented Dr. Joseph H. Crabb, vice president and chief scientific officer.
The Company demonstrated the effectiveness of its patented colonic delivery technology in a July 1997 bioavailability study. The intellectual property underlying DiffGAM is the subject of one additional patent issued to the Company and two patents licensed by the Company.
ImmuCell's milk antibody product development effort has been supported by approximately $1,900,000 in research grant funding from the National Institutes of Health since 1991. Additional, partner-funded studies will be required before an application for licensure could be submitted to the FDA for review. The Company is hopeful that these clinical results are sufficient to attract a corporate partner to continue clinical development, regulatory oversight, and marketing of the product. If the product is successfully developed and achieves marketplace acceptance, the Company hopes to benefit from milestone payments, royalties on sales and a product supply agreement.
This press release contains "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company's expectations as to DiffGAM's potential efficacy, the Company's ability to enter into a partnering agreement, estimates of the market size and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's products, competition within the Company's anticipated product markets, the uncertainty of product development, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.
ImmuCell Corporation is a biotechnology company striving to build shareholder value by commercializing proprietary technologies and helping dairy and beef producers and their veterinarians manage disease and reproduction in their herds. In addition, the Company has demonstrated preliminary efficacy in an open label, Phase I/II efficacy study of DiffGAM, a human application of its milk-derived passive antibody technology for use as an alternative to antibiotics in the treatment and/or prevention of Clostridium difficile-associated diarrhea. ImmuCell is also marketing Crypto-Scan(R), a novel drinking-water test that detects the presence of Cryptosporidium in drinking-water supplies worldwide