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Iomai Receives FDA Clearance for Study Comparing Novel Flu Vaccine Patch to Traditional Injectable Vaccine |
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12 Sep 2006 |
Phase 1 study to begin enrolling patients later this month, will assess safety, immunogenicity
GAITHERSBURG, MD, USA | Sep 11, 2006 | Iomai Corporation (Nasdaq: IOMI) announced today that it has received clearance from the U.S. Food and Drug Administration to launch a head-to-head trial comparing its needle-free, patch-based influenza vaccine with the traditional vaccine, delivered via intramuscular injection. The study will enroll up to 300 patients and begin later this month. The open-label Phase 1 study will track the safety of the vaccinations and measure the immune response to both forms of the vaccine in healthy adults.
“Iomai's needle-free influenza vaccine patch is simple and easy to use, and this comparison trial will help us assess how the vaccine compares to the usual injected vaccine in the clinic,” said Stanley C. Erck, President and Chief Executive Officer of Iomai. “Public health officials have said they plan to more than double the number of people who receive an annual flu vaccination, and we believe our patch can play a crucial role in attaining that goal.”
Patients in the trial will receive either a single dose of the injectable vaccine or wear the Iomai patch, about the size of an adhesive bandage. Volunteers will then be followed to assess the safety of the vaccination methods, and researchers will use blood tests to assess the immune response generated by each method.
The influenza vaccine patch uses Iomai's proprietary transcutaneous immunization (TCI) technology, which delivers vaccine to a group of antigen-presenting cells in the skin called Langerhans cells. Those cells, in turn, transport the vaccine to nearby lymph nodes to produce a sustained immune response.
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, enable 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 E. coli-related travelers' diarrhea. For more information on Iomai, please visit 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 make comparisons directly with injectable influenza vaccines, the attributes of Iomai's needle-free influenza vaccine, and the role of Iomai's needle-free flu vaccine 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 make definitive comparisons with injectable influenza vaccines; 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 influenza vaccines; that results in this and future clinical trials may fail to demonstrate our TCI technology is simple and easy to use; that Iomai's product candidates may not satisfy public health needs when marketed; 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, 2006 and its Annual Report on Form 10-K for the year ended December 31, 2005 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 www.sec.gov.
These statements speak only as of the date of this document, and Iomai undertakes no obligation to update or revise the statements.
Company Contacts:
Russell P. Wilson
Senior Vice President, Chief Financial Officer and General Counsel
Iomai Corporation
301-556-4478
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Brian Reid
WeissComm Partners, Inc.
703-402-3626
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SOURCE Iomai Corporation |
