- Trial to Assess Safety and Dose-Sparing Capability of Iomai Adjuvant
GAITHERSBURG, Md., Sept. 6 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced that it has begun dosing in a Phase 1/2 study that will assess the safety and dose-sparing capability of the company's immunostimulant patch when used in combination with an injected H5N1 influenza vaccine.
The Iomai patch, which contains a powerful immune-stimulating adjuvant, is used in conjunction with an injected influenza vaccine and may generate an immune response with small amounts of vaccine antigen. If successful, Iomai's approach may expand the pandemic influenza vaccine supply in the event of an influenza pandemic. This clinical trial is funded through an advanced development contract from the U.S. Department of Health and Human Services.
"This is the first human trial of the Iomai immunostimulant patch for use with a pandemic-like influenza vaccine, and the results of this study will give us crucial information about the ability of the patch to extend the vaccine supply in the event of a pandemic," said Stanley C. Erck, president and chief executive officer of Iomai. "Our patch is designed to solve the pressing problem of inadequate pandemic vaccine stocks, and we believe the results of this trial will validate our unique and flexible dose-sparing approach."
The study will enroll as many as 500 subjects, who will receive either a placebo injection or one of three dosages of pandemic influenza vaccine. Patients will receive a booster shot of placebo or vaccine 21 days later. Of these patients, approximately one-third will receive no immunostimulant patch, one-third will receive a patch only with the booster shot, and one-third will receive a patch with both vaccine injections. Subjects will be followed for safety, and immune responses to the pandemic vaccine will be evaluated.
Existing pandemic influenza vaccine manufacturing capacity is limited presently, and research to date suggests that the amount of vaccine antigen required to generate a protective effect is far higher than the amount of vaccine needed for protection from seasonal influenza. While development of adjuvants -- compounds that increase the body's immune response to vaccines - has accelerated in recent years, existing efforts have focused on combining adjuvant with antigen in a single shot. Iomai is unique in developing a patch- based adjuvant that may be used with any manufacturer's vaccine.
About Iomai Corporation
Iomai Corporation discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent travelers' diarrhea. For more information on Iomai, please visit http://www.iomai.com.
Some matters discussed in this press release constitute "forward-looking statements" that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Such forward-looking statements include statements about the timing and size of enrollment of volunteers for the trial described in this press release, Iomai's ability to obtain information from this trial sufficient to assess the safety and dose-sparing capability of its immunostimulant patch, ability of Iomai's immunostimulant patch to extend the pandemic flu vaccine supply, attributes of Iomai's immunostimulant patch to be used with any manufacturer's vaccine, and the role of Iomai's immunostimulant patch in attaining public health immunization goals. Applicable risks and uncertainties include, among others, that Iomai may not be able to enroll sufficient numbers of patients in this and future clinical trials; that the timing of clinical trials is dependent on sufficient coordination and cooperation with third-party clinical research organizations; that the results in the trial described in this press release may not provide the needed information necessary to assess the safety and dose-sparing capability of Iomai's immunostimulant patch; that future clinical trials may not replicate results sought in the trial described in this press release; that Iomai may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials or to market any product candidates for its immunostimulant patch; that results in this and future clinical trials may fail to demonstrate Iomai's immunostimulant patch is a unique and flexible dose-sparing approach; that Iomai's product candidates may not satisfy public health needs when development is complete; that development costs may exceed expectations; that Iomai may fail to adequately protect its intellectual property or may be determined to infringe on the intellectual property of others; and the risks identified under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the three months ended June 30, 2007 and its Annual Report on Form 10-K for the year ended December 31, 2006 and filed with the Securities and Exchange Commission. Iomai cautions investors and others not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read the Company's filings for a discussion of these and other risks and uncertainties which are filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.
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