surf1944
16 years ago
Iomai being acquired by vaccine maker Intercell
Tuesday May 13, 7:56 am ET
Iomai selling to Intercell for $189 million; deal will combine 2 vaccine franchises
GAITHERSBURG, Md. (AP) -- Biotechnology company Iomai Corp. said late Monday it is being bought by vaccine developer Intercell AG for about $189 million, as part of that company's effort to expand its late-stage pipeline.
The $6.60-per-share deal marks a 126 percent premium from Iomai's closing price of $2.92 Monday. The buyout will involve a stock-for-stock exchange for about 41 percent of Iomai's outstanding shares held by major shareholders for about 1.7 million Intercell shares. That represents about 4 percent of Vienna-based Intercell.
The remaining Iomai shares will be bought in a cash deal.
In a statement, Iomai said the deal will bring together Intercell's Japanese Encephalitis vaccine with Iomai's needle-free travelers' Diarrhea vaccine, expected to enter late-stage studies in the first half of 2009. Combined, both vaccines represent a market opportunity of about $1 billion annually, Iomai said.
Both companies boards of directors have approved the deal, which is expected to close before the end of the third quarter.
Merrill Lynch International acted as exclusive financial adviser to Intercell and Cowen and Co. provided a financial fairness opinion to Iomai's Board of Directors.
Intercell's stock is traded on the Vienna Stock Exchange.
surf1944
16 years ago
Iomai Receives HHS Approval to Begin Phase 2 Trial of H5N1 Influenza Adjuvant Patch
Tuesday April 15, 8:00 am ET
- Dose-Ranging Trial to Further Assess Feasibility of Dose-sparing and Single-Dose Vaccination Against H5N1 Flu -
GAITHERSBURG, Md., April 15 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced that it has received approval from the Department of Health and Human Services (HHS) to expand its program to develop an immunostimulant adjuvant patch for use with an injected H5N1 influenza vaccine. This decision was based upon positive clinical data generated in a 500-subject, Phase 1/2 study recently completed by Iomai.
Guided by data from this study, Iomai will begin a Phase 2 dose-ranging study designed to identify the optimum dose of antigen and adjuvant that can be used in a one-dose or two-dose regimen to enhance the immune response to a H5N1 influenza vaccine. As the majority of current approaches to pandemic influenza vaccines require two doses, given 3 or 4 weeks apart, a single-dose strategy would significantly simplify the logistics of a mass vaccination program.
Last month, Iomai announced the results of the first clinical trial of the patch when used with an injectable H5N1 influenza vaccine. That trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai adjuvant patch, was sufficient to provide an immune response considered protective in 73 percent of those tested, a statistically significant improvement over those who received the H5N1 influenza vaccine alone. A second dose of both vaccine and patch further enhanced immunogenicity; 100 percent of subjects who received two 45-microgram doses of vaccine and two Iomai patches had a measurable immune response, and 94 percent of these subjects had immune responses considered protective.
"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "Based on the data from this new Phase 2 study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase 3 trial. Our work would not be possible without the enthusiasm and commitment of HHS throughout the process."
This research is being funded under a $128 million contract awarded by HHS in January 2007. Of this amount, $14.5 million was targeted toward completion of the Phase 1/2 study. Using the results of this trial, Iomai is currently working with HHS to refine the clinical development plan and budget for the new Phase 2 trial going forward.
surf1944
16 years ago
Iomai Wins Department of Defense Grant to Develop a Stable, Patch-Based Anthrax Vaccine
Tuesday April 8, 8:30 am ET
- Grant to Cover Formulation Work, Stability Characterization of Dry-Patch Vaccine -
GAITHERSBURG, Md., April 8, 2008 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced it will receive a cost-reimbursement grant for up to $943,856 from the U.S. Army Medical Research and Materiel Command (USAMRMC) to perform preclinical work on a patch-based version of the anthrax vaccine.
Under the 1-year grant, Iomai scientists will use vaccine antigen developed by UK-based Avecia Biologics Ltd., applying Iomai's technology in an effort to formulate a dry version of antigen that can be combined with an Iomai adjuvant on a needle-free patch. Iomai will then evaluate the stability of the patch to determine whether it can be stored and shipped at room temperature.
The current anthrax vaccine licensed in the United States is given as a six-shot regimen over an 18-month course and must be refrigerated, complicating stockpiling efforts. Government funding for a second-generation vaccine was discontinued after problems emerged with the stability of that vaccine.
"The military has a clear need for an effective anthrax vaccine that can be stockpiled and shipped at room temperature, and we believe that Iomai has the scientific know-how and the manufacturing ability to meet that need," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "This grant further validates the Iomai approach of formulating vaccines and immunostimulants on stable dry patches, and our work under this grant will dovetail nicely with our ongoing clinical and preclinical programs."
The work on the Department of Defense grant will focus on Iomai's technology for drying proteins such as the anthrax vaccine so that they can be administered via a patch the size of an adhesive bandage. That technology is at the core of the company's vaccines for travelers' diarrhea and influenza as well as its immunostimulant adjuvant patches for pandemic influenza and seasonal flu in the elderly.
The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Government, and no official endorsement should be inferred.
surf1944
16 years ago
Iomai and Merck & Co., Inc. Evaluate Use of Iomai Immunostimulant Patch
Thursday April 3, 7:30 am ET
- Merck to Conduct Preclinical Proof-of-Principle Studies -
GAITHERSBURG, Md., April 3, 2008 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced that it has signed an agreement with Merck & Co., Inc. to conduct proof-of-principle preclinical studies evaluating the use of the Iomai needle-free immunostimulant patch.
Merck has first option to negotiate an exclusive license. These preclinical proof-of-principle studies will be conducted using an undisclosed Merck vaccine. Iomai recently announced results of a 500-person Phase 1/2 trial in which a clinically relevant adjuvant effect was observed when a version of the immunostimulant patch was administered in combination with an injected vaccine for pandemic influenza, and data from a prior European trial demonstrated the ability of the immunostimulant patch to boost the immune response of the elderly who receive an injected seasonal influenza vaccine.
"This agreement with Merck allows us to further evaluate the possible applications of our patch," said Stanley C. Erck, president and chief executive officer of Iomai. "Our immunostimulant patch has the potential to improve the immune response to a wide variety of vaccines, allowing for more effective vaccines, or vaccines that work at a lower dose."
The Iomai approach uses a potent adjuvant, applied to the skin through a patch that is affixed over the site of the injected vaccine. Once the patch is applied, the adjuvant passes into the skin, targeting cells called Langerhans cells. Those specialized skin cells carry the adjuvant into the lymph nodes, where it works to boost an individual's immune response to the vaccine. This proprietary approach is known as transcutaneous immunization (TCI).
Last year, the Department of Health and Human Services (DHHS) awarded Iomai a $128 million contract to fund the company's development of a dose-sparing patch for use with a pandemic influenza vaccine, and that contract is currently funding the Phase 1/2 pandemic influenza trial. The patch being used in that program is similar to the one that will be used in the Merck collaboration, with the same adjuvant and delivery system.
surf1944
16 years ago
Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels
Thursday March 20, 7:00 am ET
- HHS Now Reviewing Data to Determine Next Steps in $128 Million Contract -
GAITHERSBURG, Md., March 20 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced positive interim results from the 500-subject Phase 1/2 trial of its immunostimulant adjuvant patch used with an injected vaccine for H5N1 influenza. The trial met a key endpoint, demonstrating a clinically relevant adjuvant effect when the Iomai patch was used with a single dose of the 45-microgram H5N1 vaccine. The trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai patch, was sufficient to provide an immune response considered protective in 73 percent of those tested, a statistically significant improvement over those who received the H5N1 influenza vaccine alone.
This is one of the first trials to demonstrate that a single dose of pandemic influenza vaccine may meet the level of protection suggested in U.S. Food and Drug Administration guidance, which recommends that a pandemic vaccine achieve immune response levels considered protective in 70 percent or more of vaccine recipients. The trial was conducted under a $14.5 million contract with the U.S. Department of Health and Human Services (HHS) with the potential for an additional $114 million in follow-on funding. Iomai has shared the data with HHS and is now working with them to determine the next steps.
The only FDA-approved vaccine in the United States for the avian influenza H5N1 virus requires two 90-microgram doses, administered 28 days apart, to achieve hemagglutinin inhibition (HI) titers equal to or greater than 40 in 44 percent of vaccinated individuals.
"During an influenza pandemic, public health officials will face two large hurdles. The first is the possibility of limited vaccine stocks. The second is the logistic difficulty of administering two vaccinations over a period of several weeks to all individuals in the face of a pandemic. This new research clearly indicates that a single dose of vaccine in combination with an Iomai patch could provide a significant level of protection, achieve protective levels more rapidly, and increase compliance," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "This is a major breakthrough and could provide public health officials with an important solution for this looming problem."
The trial tested three different dose levels of Solvay Biologicals, B.V. (Netherlands) egg-derived H5N1 influenza vaccine, the adjuvant patch and placebo to determine which combinations would be most effective in a two-immunization regimen, administered 21 days apart. Data showed that 92 percent of the 50 subjects vaccinated a single time with the 45-microgram dose in combination with the Iomai patch had an immune response. Seventy-three percent of those subjects achieved an HI titer of greater than 40, which is considered protective, offering the potential to eliminate the need for a second vaccination. About 49 percent of those who received the vaccine alone, without a patch, had an immune response considered protective after the first dose, and the 24 percentage point difference between the patch and no-patch groups was statistically significant (p<0.0001). A second dose of both vaccine and patch further enhanced immunogenicity; 100 percent of subjects who received two 45-microgram doses of vaccine and two Iomai patches had a measurable immune response, and 94 percent of subjects had immune responses considered protective.
No treatment-related serious adverse events were reported.
With further testing, the patch has the potential to be used in conjunction with other injected pandemic influenza vaccines. It has been shown to be suitable for ambient temperature shipping and handling, and has at least a 2-year storage shelf life, making the product ideal for stockpiling and rapid distribution. The patch is easily applied and acts like an adhesive bandage placed at the site of the injection.
"This data also confirms our general approach of using an adjuvant patch to improve the immune response to injected vaccines and the ability of our adjuvant to safely and effectively stimulate robust immune responses via the skin," said Gregory Glenn, Iomai's Chief Scientific Officer. "We continue to explore ways to bring this approach to other applications in the high-value field of vaccine adjuvants."
surf1944
16 years ago
Iomai Announces Year-End 2007 Financial Results and Business Progress
Thursday March 6, 8:00 am ET
Conference Call at 1:30 p.m. Eastern Time Today
GAITHERSBURG, Md., March 6 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today reported financial results and corporate progress for the full year ended December 31, 2007.
"In the past few months, we have further demonstrated that Iomai's vaccine and immunostimulant patches can be safely and effectively self-applied," said Stanley C. Erck, president and chief executive officer of Iomai. "This lays the foundation for a revolution in the way vaccination is approached. Rather than shots at a doctor's office or travel clinic, we believe we have a platform that makes possible a vaccine that could be mailed to consumers and self-applied."
"2007 was a groundbreaking year for Iomai, with the positive results from the Phase 2 field study of our travelers' diarrhea vaccine and the $128 million government contract to fund the development of our adjuvant patch for pandemic influenza," continued Mr. Erck. "This year, we hope to build on those achievements by pursuing a partnering deal, announcing results from the Phase 1/2 trial of our adjuvant patch for pandemic influenza and preparing to conduct a pivotal Phase 3 trial for our travelers' diarrhea vaccine in 2009."
Full-Year and Fourth Quarter 2007 Financial Results
For the full year ended Dec. 31, 2007, Iomai reported a net loss available to common stockholders of $28.3 million, or $1.16 per share, compared to a net loss of $32.3 million, or $2.03 per share, for the year ended Dec. 31, 2006. The lower net loss per share in 2007 was attributable to increased revenues principally under our Department of Health and Human Services ("DHHS") contract, which was awarded in January 2007 and the increased number of shares outstanding as a result of our $30.2 million private placement completed on March 2, 2007. For the fourth quarter of 2007, Iomai's net loss was $6.2 million, or $0.24 loss per share, compared to a net loss in the fourth quarter of 2006 of $9.9 million, or $0.53 loss per share. As of Dec. 31, 2007, Iomai had common stock outstanding of 25,588,673 shares.
The Company reported revenues of $10.7 million for the year ended Dec. 31, 2007, compared to $1.5 million in the year ended Dec. 31, 2006. The increase in revenue in 2007 was principally from the reimbursement of expenses incurred under the DHHS contract. Iomai reported revenues of approximately $3.3 million in the fourth quarter of 2007, compared to approximately $40,000 in the fourth quarter of 2006.
Total operating expenses were $39.8 million in 2007, compared to operating expenses of $33.9 million in 2006. The increase in operating expenses was primarily due to five major factors associated with supporting our development programs: (1) higher payroll and stock compensation costs associated with a 28% increase in full-time employee equivalents, (2) higher facility costs associated with leasing additional space, (3) increased animal study costs associated with work performed under our DHHS contract, (4) higher contract manufacturing costs associated with procuring and finishing the pandemic flu vaccine for the clinical trial under the DHHS contract, and (5) higher consulting costs associated with market studies for our product candidates. These increased costs were partially offset by lower development costs for our skin preparation system.
Total operating costs for the fourth quarter of 2007 were $9.6 million as compared to $10.1 million for the fourth quarter of 2006. The decrease in operating expenses was primarily due to decreased in year-to-year clinical trial costs for Iomai's needle-free travelers' diarrhea vaccine and decreased contract manufacturing expenses.
As of Dec. 31, 2007, Iomai had unrestricted cash and cash equivalents and marketable securities of $15.5 million compared to $22.0 million on Sept. 30, 2007.
Iomai expects to be able to fund its capital expenditures and operations with its current working capital and reimbursement of expenses under our existing government grants and contracts into the third quarter of 2008.
Conference Call Details
To access the live conference call on Thursday, March 6 at 1:30 p.m. Eastern Time via phone, please dial 866-578-5784 from the United States and Canada or 617-213-8056 internationally. The conference ID is 87233725. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through March 10 and may be accessed by dialing 888-286-8010 from the United States and Canada or 617-801-6888 internationally. The replay passcode is 74369365.
To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the Company's website at http://www.iomai.com. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary. The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at http://www.earnings.com, Thomson's individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (http://www.streetevents.com), a password-protected event management site.
surf1944
16 years ago
Iomai Study Shows Self-Applied Travelers' Diarrhea Vaccine Patch Comparable to Clinician-Applied Vaccine Patch
Tuesday February 12, 8:30 am ET
GAITHERSBURG, Md., Feb. 12 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced the interim results of a study that showed that the second dose of the two-dose regimen for its novel, patch-based travelers' diarrhea vaccine yields a robust immune response when self-applied by subjects outside of a clinical setting.
The 160-subject study, part of an extensive Phase 2 program for the vaccine, measured the immune response to the vaccine patch, which is approximately the size and shape of an adhesive bandage. Four groups were evaluated: two groups received both doses of the vaccine from a medical professional and two other groups of volunteers administered the second vaccine patch themselves. All groups had robust responses to the vaccine, and a statistical analysis of immune parameters following vaccination showed no significant differences between treatment groups at any time point.
"These results confirm our belief that the Iomai patch can be effectively used by patients without a health care provider present, removing the need for a second trip to a travel clinic," said Stanley C. Erck, Iomai's president and chief executive officer. "Our research has shown that self-application of the second dose further enhances the market potential of this product."
As with past studies of the vaccine, no serious vaccine-related adverse events were reported.
Iomai is completing its Phase 2 program and plans to conduct a Phase 3 efficacy study during summer of 2009, when the travelers' diarrhea season in Latin America is at its peak. Based on the results of the self-application study, Iomai is evaluating the feasibility of including self-administration of the second vaccine dose in that Phase 3 study. The data also suggests the possibility of self-administration of other Iomai vaccines, such as the needle-free influenza vaccine, which remains a priority for the company.
Last year, the company presented data from a Phase 2 field trial of the travelers' vaccine at the Interscience Conference on Antimicrobial Agents and Chemotherapy that demonstrated people who received the vaccine before traveling to Mexico or Guatemala were significantly less likely to report clinically significant diarrhea. Of the 59 individuals who received the vaccine, only three suffered moderate or severe diarrhea, while 23 of the 111 who received a placebo suffered moderate or severe diarrhea, a 75 percent reduction (p=0.007). One of the 59 volunteers in the vaccine group reported severe diarrhea, compared with 12 of the 111 in the placebo group, an 84 percent reduction (p=0.033).
About Travelers' Diarrhea
This year, approximately 55 million international travelers will visit countries where bacteria that cause travelers' diarrhea are endemic, particularly Africa, Asia and Latin America, and about 20 million of those travelers will develop travelers' diarrhea.
A recently completed market study suggested that there is a large market for an effective travelers' diarrhea vaccine, potentially exceeding $750 million annually. If approved, the Iomai vaccine would be the first vaccine for travelers' diarrhea available in the United States.
surf1944
16 years ago
Iomai CEO to Speak at BIO CEO & Investor Forum on Feb. 12
Wednesday February 6, 8:30 am ET
GAITHERSBURG, Md., Feb. 6 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced that Stanley C. Erck, the company's president and chief executive officer, will present at the 10th Annual BIO CEO & Investor Conference in New York City on Tuesday, Feb. 12. Mr. Erck's presentation will begin at 2 p.m. Eastern Time in the in New Amsterdam Suite of the Waldorf-Astoria.
http://biz.yahoo.com/prnews/080206/aqw076.html?.v=35
surf1944
17 years ago
Iomai Patch-Based Vaccine Cut Rate of Travelers' Diarrhea by 75 Percent in Phase 2 Field Study
Statistically Significant Data Detailed at a Late-Breaking Presentation at ICAAC Meeting
CHICAGO and GAITHERSBURG, Md., Sept. 18 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced that travelers who received the company's patch-based travelers' diarrhea vaccine were significantly less likely to be sickened as compared with travelers who receive a placebo, according to research presented today by Chief Scientific Officer Gregory Glenn, M.D. at a late-breaker presentation during the 'Vaccines and Pediatric Infections' session of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy being held in Chicago.
'We have demonstrated that vaccinated travelers can dramatically cut their risk of diarrhea by using our needle-free patch,' said Dr. Glenn, Iomai's founder. 'Those who received the Iomai vaccination were much less likely to get sick, and those who were sickened had far milder illness than those who received a placebo. These are clinically significant results that suggest that the patch vaccine will address the most significant unmet need for travel medicine: prophylaxis for travelers' diarrhea.'
The study found that of the 59 individuals who received the novel, patch-based vaccine, only three suffered moderate or severe diarrhea, while 23 of the 111 who received a placebo suffered moderate or severe diarrhea, a 75 percent reduction (p=0.007). One of the 59 volunteers in the vaccine group reported severe diarrhea, compared with 12 of the 111 in the placebo group, an 84 percent reduction (p=0.033).
'The results presented at ICAAC are the most robust ever shown in the prevention of travelers' diarrhea, and they suggest we may be near a turning point in the prevention of this common, often-serious disease,' said Herbert L. DuPont, M.D., professor and director of the Center for Infectious Diseases at The University of Texas School of Public Health and the principal investigator on the trial. 'If Phase 3 trials for the vaccine validate these results, those of us in travel medicine will have an excellent new weapon in our arsenal.'
The research was conducted in collaboration with researchers from the Johns Hopkins Bloomberg School of Public Health and the University of Texas School of Public Health.
Iomai plans to begin a Phase 3 program for the needle-free vaccine patch vaccine in 2008.
'We are moving this product ahead as quickly as possible,' said Chief Executive Officer Stanley C. Erck. 'This is a pressing, unmet medical need. Travelers' diarrhea is the most common travel ailment in the world, yet there are no effective vaccines available for the condition. A recently completed market study suggests that there is a $750 million market for effective protection against travelers' diarrhea, an opportunity that we are well-positioned to target.'
About the Phase 2 Trek Study
The Trek Study followed 170 travelers to Mexico and Guatemala. Each volunteer received either two doses of the Iomai vaccine patch or a placebo, 2 to 3 weeks apart, with the last dose administered a week before travel. Travelers kept detailed diaries and received in-country checkups. The study met its primary endpoints, which were designed to evaluate the safety of the vaccine and the incidence of enterotoxigenic E. coli (ETEC) bacteria -- the most common cause of travelers' diarrhea. No vaccine-related serious adverse events were reported.
Of the few vaccinated patients who were sickened, the diarrhea lasted only half a day on average, while those in the placebo group endured two days of illness and more than twice as many loose stools. Although not statistically significant, the frequency of new-onset irritable bowel syndrome, a long-term consequence of travelers' diarrhea, was three times greater in placebo than vaccine recipients.
Iomai's vaccine uses an ETEC toxin delivered via a skin patch using the company's novel transcutaneous immunization (TCI) technology. ETEC causes illness through the toxins it produces, including one known as heat-labile toxin or LT. Iomai's unique patch-based vaccine enables the safe administration of this potent immunogen into the skin to stimulate the immune response.
About Travelers' Diarrhea
This year, approximately 55 million international travelers will visit countries where bacteria that cause travelers' diarrhea are endemic, particularly Africa, Asia and Latin America, and about 20 million of those travelers will develop travelers' diarrhea.
A recently completed market study suggested that there is a large market for an effective travelers' diarrhea vaccine, potentially exceeding $750 million annually. If approved, the Iomai vaccine would be the first vaccine for travelers' diarrhea available in the United States.
ETEC's impact goes beyond travelers. The World Health Organization estimates that children in the developing world suffer 210 million episodes of diarrhea caused by ETEC annually, causing 380,000 deaths each year.
surf1944
17 years ago
Iomai Launches Phase 1/2 Safety Study of Dose-Sparing Patch for Use With Pandemic Influenza Vaccine
- Trial to Assess Safety and Dose-Sparing Capability of Iomai Adjuvant Patch -
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.
SOURCE Iomai Corporation
Source: PR Newswire (September 6, 2007 - 7:30 AM EST)
surf1944
17 years ago
Iomai Announces Data from Phase 2 Field Study of Travelers' Diarrhea Vaccine Accepted for Presentation at ICAAC
GAITHERSBURG, Md., Aug. 23 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced that the abstract detailing efficacy and safety results from its double-blind Phase 2 field study of a patch-based vaccine for travelers' diarrhea has been accepted as a 'late breaker' presentation at Interscience Conference on Antimicrobials and Chemotherapy (ICAAC), to be held in Chicago Sept. 17 to 20.
The abstract, 'Transcutaneous Immunization with the Heat Labile Toxin (LT) of Enterotoxigenic Escherichia coli (ETEC) Protects in a Phase 2 Field Trial in Travelers to Guatemala and Mexico,' will be presented by Gregory Glenn, M.D., Iomai's chief scientific officer, on Tuesday, Sept. 18, during the session on 'Vaccines and Pediatric Infections.' The session will be held from 1:30 to 4 p.m.
About Travelers' Diarrhea
This year, approximately 55 million international travelers will visit countries where bacteria that cause travelers' diarrhea are endemic, particularly Africa, Asia and Latin America, and about 20 million of those travelers will develop travelers' diarrhea.
Travelers' diarrhea (TD) is caused by ingestion of pathogens in contaminated food and water. Of the 54 million travelers to endemic areas, an estimated 17 million will contract TD, making it one of the most common illnesses in travelers. Symptoms last for 3 to 5 days, and 55 percent of subjects who become ill have more than six stools daily, with an average of 18 total stools per episode. TD is often accompanied by nausea, vomiting and cramping and can result in severe dehydration, mimicking the symptoms of cholera. Although generally self-limited, TD is often accompanied by prostration and can require hospitalization, often in settings where health care is inadequate. Additionally, 10 to 30 percent of travelers who contract diarrhea also develop a more chronic condition, irritable bowel syndrome.
surf1944
17 years ago
Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers' Diarrhea Patch Vaccine
GAITHERSBURG, Md., Aug. 9 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced that interim results from a Phase 1 safety and immunogenicity trial of its patch-based vaccine for travelers' diarrhea found that all subjects who received the vaccine -- 19 elderly and 17 adult participants -- mounted an immune response, demonstrating that even elderly subjects with weaker immune systems respond to the vaccine.
The trial was designed to compare the number of elderly subjects (65 and older) who seroconverted -- developed antibodies to the vaccine's active ingredient -- with the number of adult participants (aged 18 to 40) who seroconverted. Because the immune system is often less powerful in older people, many vaccines do not work as well in the elderly. However, all subjects who received the Iomai patch, regardless of age, seroconverted with IgG antibodies. Moreover, 18 of 19 elderly subjects and 15 of 17 adult subjects also seroconverted with IgA antibodies. The study was conducted in Belfast, Ireland, and subjects received two patches, 21 days apart, containing 'heat labile' toxin, or LT, and were followed for 42 days. No treatment- related serious adverse effects were reported.
'The results of this trial further confirm that we can effectively deliver the active ingredient in our patch-based vaccine for travelers' diarrhea to adults of all ages, and based on this data, the Iomai travelers' diarrhea vaccine could be expected to extend coverage to this important at-risk segment of the traveling population,' said Gregory M. Glenn, M.D., senior vice president and chief scientific officer of Iomai. 'These results, coupled with the remarkable findings from our field study that we announced last week, provide additional evidence of the significant potential for Iomai's transcutaneous immunization (TCI) approach.'
Iomai last week announced that a Phase 2 field trial of the vaccine found that healthy adults who traveled to Guatemala and Mexico and were vaccinated with the Iomai patch were 75 percent less likely to suffer moderate or severe travelers' diarrhea. With the high seroconversion rates in the elderly, the interim results from this new study suggest that the protective effect of Iomai's travelers' diarrhea vaccine may apply to all adults, not just young adults. Iomai will look to confirm this in its Phase 3 trials for its travelers' diarrhea vaccine, which the company intends to launch in 2008.
The study was designed to evaluate the safety of the travelers' diarrhea vaccine patch in the elderly and it met this primary endpoint. The secondary objective included evaluation of immunogenicity of the vaccine in the elderly compared with young adults. Iomai plans to submit the study data from the trial for publication as soon as possible.
ABOUT TRAVELERS' DIARRHEA
This year, approximately 55 million international travelers will visit countries where bacteria that cause travelers' diarrhea are endemic, particularly Africa, Asia and Latin America, and about 20 million of those travelers will develop travelers' diarrhea.
ETEC, the most common cause of travelers' diarrhea, represents just under half of all cases of travelers' diarrhea for international travelers to areas where ETEC is common. A recently completed market study suggested that there is a large market for an effective ETEC vaccine, potentially exceeding $500 million annually. If approved, the Iomai vaccine would be the first vaccine for travelers' diarrhea available in the United States.
ETEC's impact goes beyond travelers. The World Health Organization estimates that children in the developing world suffer 210 million episodes of diarrhea caused by ETEC annually, causing 380,000 deaths each year.
BRIG_88
17 years ago
Iomai to Present at BIO CEO & Investor Conference
Last update: 2/9/2007 8:30:00 AM
GAITHERSBURG, Md., Feb 09, 2007 /PRNewswire-FirstCall via COMTEX/ -- Iomai Corporation (IOMI) today announced that Stanley C. Erck, the company's president and chief executive officer, will speak at the 9th Annual BIO CEO & Investor Conference on Tuesday, February 13 at 9:45 a.m. Eastern Time. In addition, Mr. Erck will take part in a panel discussion, "The Pandemic Panic," taking place Monday, February 12 at 9:30 a.m.
In his presentation, Erck will give an overview of the $128 million government contract for the study of a dose-sparing patch for use with a pandemic influenza vaccine, awarded to Iomai last month, as well as details on the company's three clinical patch-based vaccine programs.
The conference is being held at the Waldorf-Astoria Hotel in New York.
Iomai last month announced that it would receive a contract from the Department of Health and Human Services (DHHS) to fund the company's development of a dose-sparing patch for use with a pandemic influenza vaccine. If the product is developed through licensure, the total cost reimbursed by DHHS, plus the fixed fee, is estimated to be $128 million.
To access the live audio webcast or the subsequent archived recording, log on to the Investor Relations section on the Overview page of the Iomai website at . Please connect to Iomai's website several minutes prior to the start of the live webcast to ensure adequate time for any software downloads that may be necessary.
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