Avant Immunotherapeutics

The following are excerpts, highlighted in red, from the final legislation and/or conference report which contain National Academies' studies. (Pound signs [##] between passages denote the deletion of unrelated text.)

HR1298 Hyde (R-Ill.) 5/21/03
Enrolled (finally passed both houses)

To provide assistance to foreign countries to combat HIV/AIDS, tuberculosis, and malaria, and for other purposes.
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE. --This Act may be cited as the "United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003".

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SEC. 101. DEVELOPMENT OF A COMPREHENSIVE, FIVE-YEAR, GLOBAL STRATEGY.

(a) STRATEGY. --The President shall establish a comprehensive, integrated, five-year strategy to combat global HIV/AIDS that strengthens the capacity of the United States to be an effective leader of the international campaign against HIV/AIDS. Such strategy shall maintain sufficient flexibility and remain responsive to the ever-changing nature of the HIV/AIDS pandemic and shall--

(1) include specific objectives, multisectoral approaches, and specific strategies to treat individuals infected with HIV/AIDS and to prevent the further spread of HIV infections, with a particular focus on the needs of families with children (including the prevention of mother-to-child transmission), women, young people, and children (such as unaccompanied minor children and orphans);

(2) as part of the strategy, implement a tiered approach to direct delivery of care and treatment through a system based on central facilities augmented by expanding circles of local delivery of care and treatment through local systems and capacity;

(3) assign priorities for relevant executive branch agencies;

(4) provide that the reduction of HIV/AIDS behavioral risks shall be a priority of all prevention efforts in terms of funding, educational messages, and activities by promoting abstinence from sexual activity and substance abuse, encouraging monogamy and faithfulness, promoting the effective use of condoms, and eradicating prostitution, the sex trade, rape, sexual assault and sexual exploitation of women and children;

(5) improve coordination and reduce duplication among relevant executive branch agencies, foreign governments, and international organizations;

(6) project general levels of resources needed to achieve the stated objectives;

(7) expand public-private partnerships and the leveraging of resources;

(8) maximize United States capabilities in the areas of technical assistance and training and research, including vaccine research;

(9) establish priorities for the distribution of resources based on factors such as the size and demographics of the population with HIV/AIDS, tuberculosis, and malaria and the needs of that population and the existing infrastructure or funding levels that may exist to cure, treat, and prevent HIV/AIDS, tuberculosis, and malaria; and

(10) include initiatives describing how the President will maximize the leverage of private sector dollars in reduction and treatment of HIV/AIDS, tuberculosis, and malaria.

(b) REPORT.--

(1) IN GENERAL.-- Not later than 270 days after the date of enactment of this Act, the President shall submit to the appropriate congressional committees a report setting forth the strategy described in subsection (a).

(2) REPORT CONTENTS.--The report required by paragraph (1) shall include a discussion of the elements described in paragraph (3) and may include a discussion of additional elements relevant to the strategy described in subsection (a). Such discussion may include an explanation as to why a particular element described in paragraph (3) is not relevant to such strategy.

(3) REPORT ELEMENTS.--The elements referred to in paragraph (2) are the following:

(A) The objectives, general and specific, of the strategy.

(B) A description of the criteria for determining success of the strategy.

(C) A description of the manner in which the strategy will address the fundamental elements of prevention and education, care, and treatment (including increasing access to pharmaceuticals and to vaccines), the promotion of abstinence, monogamy, avoidance of substance abuse, and use of condoms, research (including incentives for vaccine development and new protocols), training of health care workers, the development of health care infrastructure and delivery systems, and avoidance of substance abuse.

(D) A description of the manner in which the strategy will promote the development and implementation of national and community-based multisectoral strategies and programs, including those designed to enhance leadership capacity particularly at the community level.

(E) A description of the specific strategies developed to meet the unique needs of women, including the empowerment of women in interpersonal situations, young people and children, including those orphaned by HIV/AIDS and those who are victims of the sex trade, rape, sexual abuse, assault, and exploitation.

(F) A description of the specific strategies developed to encourage men to be responsible in their sexual behavior, child rearing and to respect women including the reduction of sexual violence and coercion.

(G) A description of the specific strategies developed to increase women's access to employment opportunities, income, productive resources, and microfinance programs.

(H) A description of the programs to be undertaken to maximize United States contributions in the areas of technical assistance, training (particularly of health care workers and community-based leaders in affected sectors), and research, including the promotion of research on vaccines and microbicides.

(I) An identification of the relevant executive branch agencies that will be involved and the assignment of priorities to those agencies.

(J) A description of the role of each relevant executive branch agency and the types of programs that the agency will be undertaking.

(K) A description of the mechanisms that will be utilized to coordinate the efforts of the relevant executive branch agencies, to avoid duplication of efforts, to enhance on-site coordination efforts, and to ensure that each agency undertakes programs primarily in those areas where the agency has the greatest expertise, technical capabilities, and potential for success.

(L) A description of the mechanisms that will be utilized to ensure greater coordination between the United States and foreign governments and international organizations including the Global Fund, UNAIDS, international financial institutions, and private sector organizations.

(M) The level of resources that will be needed on an annual basis and the manner in which those resources would generally be allocated among the relevant executive branch agencies.

(N) A description of the mechanisms to be established for monitoring and evaluating programs, promoting successful models, and for terminating unsuccessful programs.

(O) A description of the manner in which private, nongovernmental entities will factor into the United States Government-led effort and a description of the type of partnerships that will be created to maximize the capabilities of these private sector entities and to leverage resources.

(P) A description of the ways in which United States leadership will be used to enhance the overall international response to the HIV/AIDS pandemic and particularly to heighten the engagement of the member states of the G-8 and to strengthen key financial and coordination mechanisms such as the Global Fund and UNAIDS.

(Q) A description of the manner in which the United States strategy for combating HIV/AIDS relates to and supports other United States assistance strategies in developing countries.

(R) A description of the programs to be carried out under the strategy that are specifically targeted at women and girls to educate them about the spread of HIV/AIDS.

(S) A description of efforts being made to address the unique needs of families with children with respect to HIV/AIDS, including efforts to preserve the family unit.

(T) An analysis of the emigration of critically important medical and public health personnel, including physicians, nurses, and supervisors from sub-Saharan African countries that are acutely impacted by HIV/AIDS, including a description of the causes, effects, and the impact on the stability of health infrastructures, as well as a summary of incentives and programs that the United States could provide, in concert with other private and public sector partners and international organizations, to stabilize health institutions by encouraging critical personnel to remain in their home countries.

(U) A description of the specific strategies developed to promote sustainability of HIV/AIDS pharmaceuticals (including antiretrovirals) and the effects of drug resistance on HIV/AIDS patients.

(V) A description of the specific strategies to ensure that the extraordinary benefit of HIV/AIDS pharmaceuticals (especially antiretrovirals) are not diminished through the illegal counterfeiting of pharmaceuticals and black market sales of such pharmaceuticals.

(W) An analysis of the prevalence of Human Papilloma Virus (HPV) in sub-Saharan Africa and the impact that condom usage has upon the spread of HPV in sub-Saharan Africa.

(c) STUDY; DISTRIBUTION OF RESOURCES.--

(1) STUDY.--Not later than 3 years after the date of the enactment of this Act, the Institute of Medicine shall publish findings comparing the success rates of the various programs and methods used under the strategy described in subsection (a) to reduce, prevent, and treat HIV/AIDS, tuberculosis, and malaria.

(2) DISTRIBUTION OF RESOURCES.--In prioritizing the distribution of resources under the strategy described in subsection (a), the President shall consider the findings published by the Institute of Medicine under this subsection

NEEDHAM, Mass., Sep 23, 2003 (BUSINESS WIRE) -- AVANT Immunotherapeutics, Inc. (AVAN) announced, prior to a presentation today at the UBS Global Life Sciences Conference in New York, that the company has reinstated development plans for its novel complement inhibitor, TP10. AVANT plans to conduct a Phase II double-blind, placebo-controlled trial of that product in approximately 200 women undergoing cardiopulmonary by-pass surgery. The trial is currently being planned to begin by year-end.

Una S. Ryan, AVANT president and chief executive officer, also reported continued advancement in AVANT's biodefense vaccine program. She said that the company had already been awarded $4 million of a potential $8 million in biodefense contracts funding the development of oral vaccines with combined protection against anthrax and plague. She also noted that the company's recently announced pilot manufacturing plant in Fall River, MA would be used for the production of these biodefense vaccines as well as the company's other bacterial vaccines.

Recommitment to TP10

"Full, detailed analysis of the data from our Phase II adult cardiac surgery study completed in February 2002 resulted in the finding of significant treatment benefits in the male participants. The benefits seen in the male population were directly related to mortality and the benefit seen was very impressive. This made it clear to AVANT's board of directors that TP10 remains an exciting product opportunity deserving further investigation by AVANT," said Una S. Ryan, AVANT president and chief executive officer. "While we continue to be open to partnering TP10, we are now convinced of this molecule's continued promise, and AVANT is very pleased to recommit to its development internally."

AVANT announced in February 2002 that preliminary analysis of clinical data from a Phase II adult cardiac surgery study of TP10 had not achieved a significant reduction in the primary endpoint of death, myocardial infarction (MI), prolonged intubation or prolonged intra-aortic balloon pumping in the prospectively defined intent to treatment population of 564 patients. The company subsequently reported in April 2003 that further data analysis showed that the male population experienced a statistically significant 36% (p=0.01) reduction in the primary endpoint, as well as a significant 43% (p=0.02) reduction in the combined endpoint of death or MI. Investigators did not see a similar effect in the female population, who comprised approximately 28% of the treated patients. TP10 was well tolerated in the overall patient population. Adverse events reported following TP10 treatment were generally similar to those seen in placebo-treated patients and were events that are routinely observed following cardiopulmonary bypass.

The proposed double-blind, placebo-controlled Phase II trial will examine the effect of 5 mg/kg TP10 versus placebo in approximately 200 women undergoing cardiac surgery, with approximately equal numbers of patients receiving placebo as receive TP10. The study, planned to begin around year-end 2003 and conclude around year-end 2004, will be conducted at approximately 10 sites throughout the United States.

"Women participating in the previous Phase II trial did not appear to benefit significantly from treatment with TP10, however we would not have expected to see benefits in such small numbers," said Dr. Ryan. "The goals of the trial are to clarify the effect that TP10 has for women undergoing cardiac surgery, as well as augment the safety data for that patient population to allow for the design of a subsequent registration-directed trial."

Dr. Ryan noted that principal clinical investigators for the adult Phase II trial of TP10 would present the full results of that study at two major upcoming scientific meetings, the American Society of Anesthesiology on October 15 and the American Heart Association on November 11.

AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune system to prevent and treat disease. The company is developing a broad portfolio of vaccines addressing a wide range of applications including bacterial and viral diseases, chronic human disease, biodefense and food safety. These include single-dose, oral vaccines that protect against important disease-causing agents and a novel, proprietary vaccine candidate for cholesterol management. AVANT's goal is to demonstrate proof-of-concept for its products before leveraging their value through partnerships. Current collaborations encompass the development of an oral human rotavirus vaccine, vaccines to combat threats of biological warfare, and vaccines addressed to human food safety and animal health.

Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: http://www.avantimmune.com