Chlamydia Vaccine A Step Closer To Reality

Scientists at Queensland University of Technology are one step closer to developing a world-first vaccine to protect women against contracting the most common sexually-transmitted disease, Chlamydia.

International vaccine company Sanofi-Pasteur has awarded QUT a funding boost of more than $300,000 to continue its research into Chlamydia and work towards developing a vaccine specifically targeting adolescent women.

Professor Peter Timms, from QUT’s Institute of Health and Biomedical Innovation (IHBI), said a team of researchers had already identified certain proteins that were able to protect against Chlamydia infection.

“We’ve been testing these proteins as part of animal trials…and we think we’ve got the answer. It is possible that within three to five years we’ll be finished the animal trials and be looking at clinical trials in humans.”

Professor Timms said Sanofi-Pasteur’s funding would allow QUT to evaluate the effectiveness of Chlamydia prevention methods developed at the university, as well as compare and test possible prevention methods being developed by Sanofi-Pasteur.

He said once a vaccine had been developed it could be administered via a patch, similar to ones used by smokers for nicotine.

“Patches are a good way to deliver proteins to a part of the body’s immune system and they are also easy and user-friendly.”

He said with rates of Chlamydia infection in some Australian communities as high as 12 per cent of the female population, there was a “real need” to develop a vaccine.

“Chlamydia is the most common infectious disease in the world and results in infertility in women and long-term chronic pelvic pain,” he said.

“There are antibiotics to treat Chlamydia, but there’s no vaccine to prevent it. In many cases women don’t know they are infected because there are not really any physical signs or symptoms, so by and large they don’t get treatment.”

Professor Timms said Sanofi-Pasteur was one of the world’s largest companies devoted to the development of human vaccines.

“The fact that such a large vaccine company as Sanofi-Pasteur has selected QUT to help develop Chlamydia vaccines points to the value of the work being done here,” he said. “Despite this current injection of funds, further work and funding is still needed to take this current research through to a vaccine product.”

QUT researchers working on the project are part of IHBI’s Cells and Tissue Domain and include Professors Peter Timms, Ken Beagley, Associate Professor Louise Hafner, Celia Berry and Chris Barker.

http://www.qut.edu.au

AAAAI: Itchy Mouth May Be Tied To Produce, Ragweed

Does your mouth or throat become itchy after eating fresh fruits or vegetables during this time of the year? For the 36 million people suffering from ragweed allergies, it is important to know about pollen-food syndrome, also known as oral allergy syndrome (OAS), caused by allergens such as ragweed, according to the American Academy of Allergy, Asthma & Immunology (AAAAI).

Each year, ragweed begins to bloom around August 15. “The pollen released from ragweed is the airborne allergen most responsible for the onslaught of allergy symptoms at this time of year,” said Suzanne S. Teuber, MD, FAAAAI, chair of the AAAAI’s Adverse Reactions to Foods Committee. “In addition to sneezing and itchy, watery eyes, and symptoms of OAS, ragweed allergies can take a heavy toll on the allergy sufferer’s quality of life.”

Oral allergy syndrome results from a cross-reactivity reaction between allergy antibodies directed towards pollen proteins with similar proteins that are found in other parts of plants. Itchiness of the mouth and throat with mild angiodema (swelling) immediately after eating fresh fruits or vegetables are common symptoms of OAS. Individuals with ragweed allergies might experience these symptoms when consuming foods such as:

— Banana

— Cucumber

— Melon

— Zucchini

— Sunflower seeds

— Chamomile tea

— Echinacea

Oral allergy syndrome is also common in people with birch tree pollen allergies. Foods that can trigger a reaction in people with this allergy are:

— Peach

— Apple

— Pear

— Cherry

— Carrot

— Hazelnut

— Kiwi

— Almonds

Generally, cooking the food will eliminate a reaction, but not always. Sometimes, it is possible for the OAS to induce severe throat swelling or even a systemic reaction in a person who is highly allergic or is allergic to the stable proteins in the food.

When to see an allergy/asthma specialist

The AAAAI’s How the Allergist/Immunologist Can Help: Consultation and Referral Guidelines Citing the Evidence provides information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:

— Have prolonged or severe symptoms of rhinitis.

— Have symptoms interfering with quality of life and/or ability to function.

— Have experienced allergic symptoms (urticaria, angiodema, itch, – wheezing, gastrointestinal responses) in association with food exposure.

— Have limited their diet based upon perceived adverse reactions to foods or additives.

— Experience an itchy mouth from raw fruits and vegetables.

— Have found medications to be ineffective or have had adverse reactions to medications.

— Are a child with allergic rhinitis, because immunotherapy may potentially prevent the development of asthma.

To find an allergist/immunologist in your area or to learn more about allergies and asthma, call the AAAAI’s Physician Referral and Information Line at (800) 822-2762 or visit the AAAAI Web site at http://www.aaaai.org.

The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has more than 6,000 members in the United States, Canada and 60 other countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at http://www.aaaai.org.

American Academy of Allergy, Asthma and Immunology
http://www.aaaai.org/

ADVENTRX Cleared To Initiate Vinorelbine Emulsion Bioequivalence Study

ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that its Investigational New Drug (IND) application for the clinical development of its proprietary cancer drug ANX-530 (vinorelbine emulsion) has been accepted by the United States Food and Drug Administration (FDA). In taking this action, the FDA acknowledged the suitability of the Company’s clinical study protocol to establish the bioequivalence of ANX-530, and Navelbine(R) (vinorelbine tartrate). Navelbine is an anti-cancer agent approved for use in non-small cell lung cancer.

Patient recruitment for this study is expected to begin in January 2007. The FDA has affirmed this 28-patient clinical study to be sufficient as a marketing-enabling trial.

“We believe ANX-530 will show bioequivalence to the marketed form of vinorelbine,” said Evan M. Levine, chief executive officer of ADVENTRX. “Further, we anticipate filing a new drug application (NDA) by the end of 2007, potentially making ANX-530 the Company’s first commercial oncology product.”

This bioequivalence study builds on promising preclinical results which demonstrated that the pharmacokinetics of ANX-530 were unchanged as compared to the approved form of vinorelbine. Furthermore, no difference in anti-tumor activity was observed between the two formulations. In addition, ANX-530 demonstrated markedly reduced vein irritation, edema, and erythema at the site of injection.

The study is a multicenter, open-label, randomized crossover comparison of ANX-530 and the approved reference product Navelbine(R) (vinorelbine tartrate) in 28 patients with advanced solid tumors. The primary objective of the study is to evaluate the pharmacokinetic profile of the two drugs in serum.

About Section 505(b)(2)

The Company plans to file an NDA for ANX-530 based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.

About ANX-530 (vinorelbine emulsion)

ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a generic chemotherapy agent. ANX-530 is designed to reduce the incidence and severity of vein irritation from IV-delivery of the drug. Vinorelbine works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing low development risk pharmaceuticals for cancer and infectious disease that enhance the efficacy and/or safety of existing therapies. More information can be found on ADVENTRX’s web site at http://www.adventrx.com.

Forward Looking Statement

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRX’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such forward-looking statements are made based on management’s current expectations and beliefs and should not be regarded as a statement or representation by ADVENTRX that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the potential to attract a strategic partner and the terms of any related transaction; the ability to timely enroll subjects in ADVENTRX’s current and anticipated clinical trials; the results of pending clinical trials for ANX-530 or ADVENTRX’s other product candidates, including the lack of bioequivalence of ANX-530 and Navelbine; the potential for ANX-530 and ADVENTRX’s other product candidates to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; other difficulties or delays in developing, testing, manufacturing and marketing of and obtaining regulatory approval for ANX-530 or ADVENTRX’s other product candidates; the market potential for vinca alkaloids and other target markets, and ADVENTRX’s ability to compete in those markets; unexpected adverse side effects or inadequate therapeutic efficacy of ANX-530 or ADVENTRX’s other products that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; the risk that preclinical and clinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical and clinical data suggests or as otherwise anticipated; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; the scope and validity of patent protection for ANX-530 and ADVENTRX’s other product candidates; and other risks and uncertainties more fully described in ADVENTRX’s press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX’s public filings with the Securities and Exchange Commission are available at http://www.sec.gov.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. All forward-looking statements are qualified in their entirety by this cautionary statement and ADVENTRX assumes no obligation to revise or update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.

ADVENTRX Pharmaceuticals
http://www.adventrx.com

Events Recognize National Black HIV/AIDS Awareness Day

Wednesday marks the seventh annual National Black HIV/AIDS Awareness Day, which aims to encourage blacks to get tested for HIV, to become educated about the virus and to receive treatment if necessary, the Chicago Tribune reports (Glanton, Chicago Tribune, 2/7). According to CDC data from 33 states published in November 2005 in the Morbidity and Mortality Weekly Report, the rate of new HIV cases among blacks has decreased an average of 5% annually since 2001, declining from 88.7 cases per 100,000 people in 2001 to 76.3 cases per 100,000 in 2004. However, blacks in 2004 were 8.4 times more likely than whites to be newly diagnosed with HIV. Blacks — who make up about 12.3% of the U.S. population — in 2004 accounted for about 49% of the estimated number of reported AIDS cases nationwide. In addition, HIV/AIDS in 2002 was the leading cause of death for black women ages 25 to 34; was among the top three causes of death for black men ages 25 to 54; and was among the top four causes of death for black women ages 25 to 54 (Kaiser Daily HIV/AIDS Report, 2/7/06). National Black HIV/AIDS Awareness Day is sponsored by the Community Capacity Building Coalition, a consortium of national minority-focused groups supported by CDC’s Division of HIV/AIDS Prevention (Kaiser Daily HIV/AIDS Report, 2/2). Events are occurring nationwide and announcements have been made in recognition of the awareness day. Highlights appear below.

Events

• Baltimore: The Institute of Human Virology will hold an open house to encourage HIV-positive people to adhere to their treatment regimens. Several clergy members and elected officials plan to receive HIV tests during the open house (Hille, Washington Examiner, 2/7).

• Delaware: The Delaware Health and Social Services Department and Beautiful Gate Outreach Center will sponsor its 6th Annual National Black HIV/AIDS Awareness Day Free Dinner Conference. The dinner will include comments from Carol Henderson Belton, an associate professor of English and black American studies at the University of Delaware, and Abbott Laboratories HIV specialist Robert Adams. In addition, speakers from local community AIDS groups will address dinner attendees (DHSS release, 2/6).
• Kentucky: This year’s observance in Kentucky will be themed “26 Years of AIDS is Enough, the Time to Deliver is Now.” The observance will feature distribution of educational material to local community events and churches, a town hall meeting, performances and workshops all focused on HIV/AIDS (Kentucky Department of Public Health release, 2/5).
• Memphis, Tenn.: The Memphis and Shelby County Health Department and local black leaders and organizations will sponsor events through Feb. 11., including discussion forums, HIV counseling and testing, and a news conference (Wilson, Eyewitness News, 2/5).
• Mississippi: HIV/AIDS advocate Marvelyn Brown on Tuesday addressed students at Jackson State University as part of the school’s commemoration of the awareness day (Jackson Clarion-Ledger, 2/6).
• Hampton, Va.: The Hampton University Student Government Association is hosting a seminar featuring HIV/AIDS-related fiction, music and poetry. Other colleges in the area are planning candlelight vigils and information sessions, and local churches have organized educational programs for ministers and the general public (Freehling, Hampton Roads Daily Press, 2/5).
• New York City: Victor Mooney, New York HIV/AIDS advocate and founder of South African Arts International, on Wednesday will unveil the design of an ocean rowboat that he will use to row across the Atlantic Ocean in an effort to raise awareness about HIV/AIDS in the U.S. and Africa, the AP/Long Island Newsday. Mooney will begin his trip on Dec. 1., which marks World AIDS Day 2007. Mooney in May 2006 attempted a similar trip that was unsuccessful (AP/Long Island Newsday, 2/7).
• Orange County, Fla.: The Orange County Health Department, the National Black Alcoholism and Addictions Council and other community partners are sponsoring several events, including a panel discussion, health fair, special screenings and the unveiling of a bus that displays HIV prevention messages (Rassel, Orlando Sentinel, 2/4).
• Tallahassee, Fla.: Sen. Frederica Wilson (D) and Rep. Curtis Richardson (D) will receive HIV tests at the state capitol on Wednesday to commemorate the awareness day and encourage residents to receive tests (Cotterell, Pensacola News Journal, 2/7).

Statements

• AIDS Action Committee of Massachusetts: AAC Executive Director Rebecca Haag said, “We must make sure that people living with HIV receive quality care and treatment, but at the same time, we must decrease the number of new” HIV cases through increased access to HIV prevention programs, particularly for minority communities (AAC release, 2/6).

• National Alliance of State and Territorial AIDS Directors: NASTAD on Wednesday announced it has released an issue brief examining HIV prevention efforts targeting black men who have sex with men (NASTAD release, 2/7).
• National Medical Association: NMA President Albert Morris in a statement said, “Special events such as free HIV/AIDS testing, town hall meetings, candlelight vigils and faith-based programs are being held throughout the country. However, we must do more to stop the spread of this disease.” He added that NMA “strongly recommends that physicians and other health care professionals offer routine HIV testing to their patients” (NMA release, 2/7).
• National Minority AIDS Council: The council on Monday announced the formation of the National Minority Policy Partnership on HIV/AIDS, an advocacy group that will lobby at local, state and federal levels to reduce HIV/AIDS among minority communities; ensure funding of HIV/AIDS prevention, diagnosis and treatment programs; reduce discrimination against black MSM; decrease the number of new HIV cases in prisons and the number of cases that occur through injection drug use; and stabilize communities at risk of HIV/AIDS (National Minority AIDS Council release, 2/5).
• NIH: In a statement to commemorate the awareness day, Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, said, “Some of the biggest challenges we face today are the misperceptions of and lack of knowledge about HIV/AIDS, and fear related to clinical research, particularly among African-Americans.” He added that he encourages blacks to “take part in the research effort in whatever way possible, as scientists, clinicians, community educators, advocates and study volunteers” (NIH release, 2/5).

Opinion Pieces
Several newspapers published opinion pieces responding to the awareness day. Summaries appear below.

• Jenice Armstrong, Philadelphia Daily News: U.S. blacks “need to stay reminded that HIV/AIDS is a scourge that shows no signs of going anywhere,” columnist Armstrong writes in a Daily News opinion piece, adding that blacks are “getting walloped especially hard” by the epidemic. According to Armstrong, it is “mind-boggling” that black people are more likely to become HIV-positive than whites (Armstrong, Philadelphia Daily News, 2/7).

• Jarvis DeBerry, New Orleans Times-Picayune: “To divide and conquer is classic military strategy, and if AIDS were a military strategist, he’d have the black community licked,” columnist DeBerry writes in a Times-Picayune opinion piece. According to DeBerry, too many people have tried to fight the spread of HIV “by looking for bogeymen within the community when, for their health’s sake, they ought to assume that everybody is a potential carrier of the disease and protect themselves accordingly.” DeBerry writes that because HIV/AIDS is widespread in the black “family,” people can “do one of two things about it. We can admit its presence and commit ourselves to fighting it together. Or we can bicker among ourselves and blame one another until there isn’t any family left” (DeBerry, New Orleans Times-Picayune, 2/6).
• Tony Norman, Pittsburgh Post-Gazette: “The spread of AIDS and HIV is the biggest public health emergency ever faced by blacks in this country,” columnist Norman writes in a Post-Gazette opinion piece. “Why, after more than two decades … are AIDS and HIV still taboo subjects in communities that can least afford to ignore them?” Norman asks, adding that “pretending” that HIV only affects other people “is a tragic fantasy” (Norman, Pittsburgh Post-Gazette, 2/6).
• Leonard Pitts, Miami Herald: The “main reason” that HIV/AIDS is so prevalent among blacks in the U.S. “is the silence, the closed-mouth social conservatism” and the “priggish moral rectitude of a people still ill at ease discussing sexuality, homosexuality, drug use and other realities,” columnist Pitts writes in a Herald opinion piece. He adds that the black community needs to “pull its collective head out of the sand” and “quit pretending homosexuality does not exist” and that injection drug use “does not exist” (Pitts, Miami Herald, 2/5).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Enzyme ENOS Plays Previously Unrecognized Role In Anaphylactic Shock

Anaphylaxis is a severe and rapid allergic reaction, and its most severe form – anaphylactic shock – can lead to death in minutes if left untreated. Anaphylactic shock can be caused by bee stings, food, medications, and latex exposure and one of the primary physical effects is dilation of blood vessels due to the production of nitric oxide (NO), resulting in dangerously low blood pressure. It is generally accepted that the enzyme inducible NO synthase (iNOS) is responsible for the excessive NO production during shock. However, in a study appearing in the August issue of the Journal of Clinical Investigation, Anje Cauwels and colleagues from Ghent University, Belgium, show that anaphylactic shock in mice was dependent entirely on NO produced not by iNOS, but by endothelial NO synthase (eNOS), which is made in endothelial cells that line blood vessels. The results show that eNOS is activated via the PI3K signaling pathway. The researchers went on to show that inhibition of NOS or PI3K, or eNOS deficiency provided complete protection against shock. The data strongly support the unexpected concept that eNOS-derived NO is the main cause of vessel dilation and low blood pressure in anaphylactic shock. In an accompanying commentary, Thomas Michel and Charles Lowenstein comment that, “these findings also suggest that inhibitors of PI3K…might plausibly be targets for the treatment of anaphylaxis.”

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TITLE: Anaphylactic shock depends on PI3K and eNOS-derived NO

AUTHOR CONTACT:
Anje Cauwels
Ghent University and Flanders Interuniversity Institute for Biotechnology, Ghent, Belgium.
E-mail: Anje.Cauwels@dmbr.UGent.be.

View the PDF of this article at: http://https://www.the-jci.org/article.php?id=25426

ACCOMPANYING COMMENTARY

TITLE: What’s in a name? eNOS and anaphylactic shock

AUTHOR CONTACT:
Thomas Michel
Harvard Medical School, Boston, Massachusetts, USA.
Emal: tmichel@research.bwh.harvard.edu.

OR

Charles J. Lowenstein
Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Email: clowenst@jhmi.edu.

View the PDF of this article at: http://https://www.the-jci.org/article.php?id=29406

Source: JCI table of contents: August, 2006

Contact: Brooke Grindlinger
Journal of Clinical Investigation

South Asians Have Higher Levels Of Heart Attack Risk Factors At Younger Ages

People who are native to South Asia experience heart attacks at a younger age because of greater levels of heart attack risk factors such as smoking and diabetes at a younger age, according to a study in the January 17 issue of JAMA.

The South Asian countries of India, Pakistan, Bangladesh, Sri Lanka, and Nepal account for about a quarter of the world’s population and contribute the highest proportion of cardiovascular diseases compared with any other region globally. Deaths related to cardiovascular disease occur 5 to 10 years earlier in South Asian countries than in Western countries, according to background information in the article. This has raised the possibility that South Asians exhibit a special susceptibility for acute myocardial infarction (AMI; heart attack) that is not explained by traditional risk factors. Despite documenting the higher rates of earlier coronary heart disease (CHD) in South Asians, few studies have been able to shed light on its reasons.

Prashant Joshi, M.D., of the Government Medical College, Nagpur, India, and colleagues attempted to determine the reasons for the higher rates of CHD in native South Asians compared with individuals from other parts of the world. The study included 1,732 heart attack patients and 2,204 controls from 15 medical centers in 5 South Asian countries and 10,728 heart attack cases and 12,431 controls from other countries.

The researchers found that the average age for first heart attack was lower in South Asian countries (53.0 years) than in other countries (58.8 years). The prevalence of protective risk factors (leisure time physical activity, regular alcohol intake, and daily intake of fruits and vegetables) were markedly lower in South Asian study participants compared with those from other countries.

Some harmful factors were more common in native South Asians than in individuals from other countries: history of diabetes, current and former smoking, history of hypertension, psychosocial factors such as depression and stress at work or home, and elevated ApoB/ApoA-I ratio (a protein/lipid). When stratified by age, South Asians had more risk factors at ages younger than 60 years.

“The younger age of first AMI among the South Asian cases in our study appears to be largely explained by the higher prevalence of risk factors in native South Asians,” the authors write. “These data suggest that lifestyle changes implemented early in life have the potential to substantially reduce the risk of AMI in South Asians.”

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(JAMA. 2007;297:286-294.)

Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Veronica McGuire
JAMA and Archives Journals

Telik Reports Preliminary Results On ASSIST-1, ASSIST-2 And ASSIST-3 Phase 3 Clinical Trials

Telik, Inc. (Nasdaq: TELK) announced preliminary results from three separate Phase 3 clinical trials of its investigational drug TELCYTA (TLK286, canfosfamide HCl).

Non-Small Cell Lung Cancer

ASSIST-2 Trial

The ASSIST-2 trial, a 520 patient multinational, randomized study designed to evaluate TELCYTA as compared to gefitinib in the third-line therapy of advanced non-small cell lung cancer, did not achieve a statistically significant improvement in overall survival, the primary endpoint.

Platinum Refractory or Resistant Ovarian Cancer

ASSIST-1 Trial

The ASSIST-1 trial, a 440 patient multinational, randomized study designed to evaluate TELCYTA as compared to the active control agents liposomal doxorubicin or topotecan in the third-line therapy of platinum resistant ovarian cancer, did not achieve its primary endpoint of demonstrating a statistically significant improvement in overall survival for TELCYTA as compared to the active controls. While the preliminary analysis revealed a number of internal inconsistencies that need to be further investigated, resolution of these inconsistencies may not change the preliminary results.

ASSIST-3 Trial

The ASSIST-3 trial, a 244 patient randomized trial conducted in the U.S., was designed to demonstrate a statistically significant improvement in overall tumor response to the combination of TELCYTA plus carboplatin compared to liposomal doxorubicin in the second-line treatment of platinum resistant ovarian cancer. Under the trial protocol, patients were to have received treatment until tumor progression or unacceptable toxicity. However, a major discordance was observed between the clinical review of the tumor scans and the independent radiology review. Approximately 25% of the patients were discontinued prematurely from the assigned study treatment as judged by the independent review of the scans. Therefore, the company believes the trial was compromised and may not be suitable for a regulatory submission. The company plans to meet with advisors to review the results and also to determine if any changes should be made to the protocol and/or trial conduct procedures for the ongoing ASSIST-5 trial.

Objective tumor responses were observed on the investigational arms containing TELCYTA in all three trials based on the prospective central blinded independent radiology review.

TELCYTA Safety

Preliminary analysis of the safety data from the ASSIST-1 and ASSIST-2 TELCYTA monotherapy trials indicates that TELCYTA was, as expected, generally well-tolerated. TELCYTA treatment was associated with mild to moderate nausea, vomiting and fatigue, mostly Grade 1 or 2. There were few Grade 3 or Grade 4 toxicities observed among the TELCYTA-treated patients on the ASSIST-1 and ASSIST-2 trials. Preliminary analysis of the safety data from the ASSIST-3 trial, combining TELCYTA plus carboplatin, demonstrated toxicities expected of each drug alone and no unexpected or cumulative toxicities were reported.

“We acknowledge and thank the patients and investigators who participated in these trials, and the entire Telik team for their efforts,” said Michael Wick M.D., PhD Chairman and Chief Executive Officer. “These results are extremely disappointing. We are conducting additional, detailed analyses of the data from these three trials and plan to discuss those results with our advisors to determine the next development steps. We plan to present data from these trials at a scientific meeting.”

Conference Call and Webcast

Telik management will host a conference call to discuss the ASSIST trial results today at 8:30 am Eastern time (5:30 am Pacific time). To access the conference call by telephone, contact 800-230-1085 or 612-332-0228. The conference call will also be available via webcast on the Telik website, http://www.telik.com/. The archived webcast and teleconference replay will be available approximately 2 hours after completion of the event through January 9, 2007. The replay will be available by telephone at 800-475-6701 or 320-365-3844, access code 857115.

About Telik

Telik, Inc. of Palo Alto, CA is a biopharmaceutical company focused on discovering, developing and commercializing novel small molecule drugs to treat serious diseases. The company’s most advanced drug development candidate is TELCYTA, a prodrug believed to be activated within cancer cells. A second drug development candidate, TELINTRA(TM) (TLK199), is in clinical development in myelodysplastic syndrome. Telik’s product candidates were discovered using its proprietary drug discovery technology, TRAP(TM), which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at http://www.telik.com/.

This press release contains “forward-looking” statements, including statements regarding the potential for TELCYTA to treat one or more types of cancer. There are important factors that could cause Telik’s results to differ materially from those indicated by these forward-looking statements, including, among others, that none of Telik’s product candidates have been determined to be safe or effective in humans or been approved for marketing, and ongoing clinical trials of Telik’s product candidates may take several years to complete and may not be successful. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its quarterly report on Form 10-Q for the quarter ended September 30, 2006. Telik does not undertake any obligation to update forward-looking statements contained in this press release.

Telik, Inc.
http://www.telik.com/

A New Fat Replacement For Trans Fat Raises Blood Sugar In Humans, Study Shows

Last month, New York City outlawed the use of partially hydrogenated oils, known as trans fats, in restaurants, a ban now under consideration in other cities, including Boston and Chicago. But novel research conducted in Malaysia and at Brandeis University shows that a new method of modifying fat in commercial products to replace unhealthy trans fats raises blood glucose and depresses insulin in humans, common precursors to diabetes. Furthermore, like trans fat, it still adversely depressed the beneficial HDL-cholesterol.

Published online in Nutrition and Metabolism (http://www.nutritionandmetabolism.com), the study demonstrates that an interesterified fat–(a modified fat that includes hydrogenation followed by rearrangements of fats molecules by the process called interesterification) enriched with saturated stearic acid–adversely affected human metabolism of lipoproteins and glucose, compared to an unmodified, natural saturated fat. Interesterification to generate a stearic acid-rich fat is fast becoming the method of choice to modify fats in foods that require a longer shelf life because this process hardens fat similar to oils containing trans-fatty acids. The new study shows that interesterification, which unnaturally rearranges the position of individual fatty acids on the fat molecule, can alter metabolism in humans.

“One of the most interesting aspects of these findings is the implication that our time-honored focus on fat saturation may tell only part of the story,” explained biologist and nutritionist K.C. Hayes, who collaborated on the research with Dr. Kalyana Sundram, nutrition director for palm oil research at the Malaysian Palm Oil Board in Kuala Lampur.

“Now it appears that the actual structure of the individual fat molecule is critical, that is, the specific location of individual fatty acids, particularly saturated fatty acids, on the glycerol molecule as consumed seems to make a difference on downstream metabolism of fat and glucose,” said Hayes. Both Hayes and Sundram are experts on human lipid metabolism and were instrumental in the development of Smart Balance® Buttery Spreads, a blend of vegetable oils that improves the cholesterol ratio.

Trans-fatty acids, which became ubiquitous in baked goods, processed foods and restaurant cooking decades ago because of their shelf life and other properties, are now being abandoned by many producers of commercial products such as cookies, crackers, pies, doughnuts, and French fries because they raise LDL (“bad”) cholesterol, lower HDL (“good”) cholesterol and contribute to heart disease.

The Malaysian-Brandeis collaboration compared trans-rich and interesterified fats with an unmodified saturated fat, palm olein, for their relative impact on blood lipids and plasma glucose. Thirty human volunteers participated in the study, which strictly controlled total fat and fatty acid composition in the subjects’ diet. Each subject consumed all three diets in random rotation during four-week diet periods. This study further confirmed previous studies in animals and humans, indicating once again that trans fats negatively affect LDL and HDL cholesterol. Surprisingly, the interesterified fat had a similar, though weaker impact on cholesterol.

“In this study we discovered that trans fat also has a weak negative influence on blood glucose. The newer replacement for trans, so-called interesterified fat, appears even worse in that regard, raising glucose 20 percent in a month,” said Hayes.

“This is the first human study to examine simultaneously the metabolic effects of the two most common replacement fats for a natural saturated fat widely incorporated in foods. As such, it is somewhat alarming that both modified fats failed to pass the sniff test for metabolic performance relative to palm olein itself,” noted Sundram.

“Whether this reflects the amount of test fat consumed, underlying genetics of the specific population examined, or some unknown factor, requires further study because the apparent adverse impact on insulin metabolism is a troubling finding,” he added.

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Contact: Laura Gardner
Brandeis University

Washington Post Columnist Examines Washington, D.C., Program Aimed At Curbing Spread Of HIV Among Injection Drug Users

Washington Post columnist Courtland Milloy on Wednesday examined PreventionWorks! — a privately funded needle-exchange program in Washington, D.C., that aims to curb the spread of HIV among injection drug users in the city. According to the district’s Administration for HIV Policy and Programs, injection drug use is the second leading mode of HIV transmission among men in the district, and it is the leading mode of transmission among women, Milloy writes. PreventionWorks! was launched in 1998 and provides counseling, treatment referrals and HIV tests to IDUs. Last year, the program had a budget of $600,000, all of which was donated. The program is run by Ron Daniels, four staff members and a group of volunteers, who visit 12 cites in the district six days weekly. Last year, the program provided 1,963 IDUs with access to educational materials, treatment referrals and clean needles. According to Milloy, the district has an estimated 9,700 IDUs. “The needle exchange is just the beginning,” Daniels said, adding, “We use the syringe to engage in conversations with those people nobody wants to talk to. We believe in meeting people where they are, treating them like human beings and helping them avoid catching and spreading diseases” (Milloy, Washington Post, 2/7).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Profiling Of Cancer Genes May Lead To Better And Earlier Detection

A research team at UT Southwestern Medical Center has for the first time identified several genes whose expression is lost in four of the most common solid human cancers – lung, breast, prostate and colon cancer.

The findings, which researchers say could form the basis for a new early detection screen for certain cancers, are published today in the online journal Public Library of Science Medicine.

The expression of genes that inhibit cancer development, so-called tumor suppressor genes, is often lost in tumor cells. This can occur through a mutation in the gene’s DNA sequence or through deletion of the gene. Loss of tumor suppression function also can occur in a process called methylation, where a chemical called a methyl group is attached to a DNA region near the gene and prevents it from being activated, essentially “silencing” the gene.

“These results show the power of studying tumors on a genome-wide basis, looking at many genes at the same time,” said Dr. John Minna, the study’s senior author and director of the W.A. “Tex” and Deborah Moncrief Jr. Center for Cancer Genetics and the Nancy B. and Jake L. Hamon Center for Therapeutic Oncology Research at UT Southwestern.

In an effort to identify new tumor-suppressor genes that might be important to lung and breast cancer development, the UT Southwestern team examined which genes are active in those kinds of tumors and compared them to gene expression profiles from normal lung epithelial cells. The researchers then examined the gene expression profiles of these various cell types before and after treatment with a drug that inhibits methylation.

The researchers identified approximately 130 genes that may be methylated and thus silenced in lung, breast, prostate and colon cancers. They analyzed 45 of these new genes in both normal and cancerous tissues from the same patients and found that many of the genes were methylated specifically in the tumor samples.

“We ended up with a large number of genes that are involved in the development of lung cancer that, despite years of work in the field, I had never connected to lung cancer before,” said Dr. Minna.

Patient samples from UT Southwestern’s new Harold C. Simmons Comprehensive Cancer Center tissue repository and previous results from study author Dr. David Euhus allowed the research team to quickly extend its findings to breast, prostate and colon cancer. A Hamon Center postdoctoral researcher and lead study author Dr. David Shames was instrumental in identifying the genes, Dr. Minna said.

“What would have normally taken us several years, David Shames was able to determine in less than a month,” Dr. Minna said. “The new genes Dr. Shames discovered are now forming the basis for a new early detection screen that could be mounted against the most common human cancers.”

The genes the researchers found to be methylated specifically in the tumor samples might control the conversion of normal cells into cancer cells, Dr. Minna said, but this possibility needs to be tested on a case-by-case basis.

Although it is known that gene expression patterns in tumors vary greatly from tissue to tissue, the researchers hope that the similarities of the methylation patterns found in this study might lead to a better approach to detect cancer early and help identify new promising therapeutic targets to treat some of the most prevalent cancers.

“The findings from our study suggest that it may be possible to develop a methylation profiling platform that could be used to screen patients for common solid tumors, while at the same time identify what type of tumor the patient may have,” Dr. Shames said.

The study also illustrates that some of the basic processes that underlie the development of breast and lung cancer are identical, even though the chemicals that initiate those processes – estrogen and tobacco carcinogens, for example – may be different, said Dr. Euhus, associate professor of surgical oncology.

“I was also struck that some of these processes could be detected in benign breast cells from high-risk women, more so than in lower-risk women,” said Dr. Euhus, co-director of the Mary L. Brown Breast Cancer Genetics and Risk Assessment Program. “Methylation is potentially a reversible change and there may be some interventions that would effectively reduce the risk of several types of cancer simultaneously.”

Other UT Southwestern researchers contributing to the study were: Drs. Luc Girard and Boning Gao, assistant professors of pharmacology; Dr. Mitsuo Sato, postdoctoral researcher in the Hamon Center; Dr. Cheryl Lewis, instructor of surgery; Dr. Narayan Shivapurkar, assistant professor of pathology; Dr. Jerry Shay, professor of cell biology; and Dr. Adi Gazdar, professor of pathology in the Hamon Center.

Additional researchers contributing to the study came from the Vanderbilt University School of Medicine in Nashville; the University of North Carolina at Chapel Hill; Stanford University; the University of Chicago; and the Memorial Sloan-Kettering Cancer Center, as well as from The Prince Charles Hospital in Australia and the University of Hong Kong.

Funding for the study came from a Specialized Program of Research Excellence grant and an Early Detection Research Network grant, both from the National Cancer Institute; the Texas Higher Education Coordinating Board Advanced Technology Program; the Gillson Longenbaugh Foundation; a NASA Specialized Center of Research grant; and the American Cancer Society.

About UT Southwestern Medical Center

UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 1,400 full-time faculty members – including four active Nobel Prize winners, more than any other medical school in the world – are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 89,000 hospitalized patients and oversee 2.1 million outpatient visits a year.

The UT Southwestern Harold C. Simmons Comprehensive Cancer Center combines the highest standards of individual care with innovative programs for cancer diagnosis, treatment and prevention based on UT Southwestern’s internationally recognized research coupled with the most sophisticated equipment and advanced technologies available. The expertise of the physicians in the Simmons Cancer Center extends to virtually every cancer in every age group, from breast, urologic, gynecologic, lung, gastrointestinal, head and neck, brain, and skin to lymphomas, leukemia, and bone marrow transplantation.

— Dr. John Minna
— Dr. David Euhus

Written by: Toni Heinzl
UT Southwestern Medical Center
www.swmed.edu