Manuka honey may kill bacteria by destroying key bacterial proteins. Dr Rowena Jenkins and colleagues from the University of Wales Institute – Cardiff investigated the mechanisms of manuka honey action and found that its anti-bacterial properties were not due solely to the sugars present in the honey. The work was presented this week (7-10 September), at the Society for General Microbiology’s meeting at Heriot-Watt University, Edinburgh.

Meticillin resistant Staphylococcus aureus (MRSA) was grown in the laboratory and treated with and without manuka honey for four hours. The experiment was repeated with sugar syrup to determine if the effects seen were due to sugar content in honey alone. The bacterial cells were then broken and the proteins isolated and separated on a system that displayed each protein as an individual spot. Many fewer proteins were seen from the manuka honey-treated MRSA cells and one particular protein, FabI, seemed to be completely missing. FabI is a protein that is needed for fatty acid biosynthesis. This essential process supplies the bacteria with precursors for important cellular components such as lipopolysaccarides and its cell wall. The absence of these proteins in honey-treated cells could help explain the mode of action of manuka honey in killing MRSA.

“Manuka and other honeys have been known to have wound healing and anti-bacterial properties for some time,” said Dr Jenkins, “But the way in which they act is still not known. If we can discover exactly how manuka honey inhibits MRSA it could be used more frequently as a first-line treatment for infections with bacteria that are resistant to many currently available antibiotics”.

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Survivors of acute lymphoblastic leukemia have a significantly increased risk of secondary cancers developing over 30 years after leukemia treatment when compared to the general population, according to a study in JAMA.

Acute lymphoblastic leukemia is the most common cancer in children and adolescents, with almost 4,000 new cases diagnosed in the United States each year. It is also one of the most curable pediatric cancers: survival rates for patients who receive contemporary treatments now exceed 80 percent, and most of these survivors are cured (no evidence of disease for at least 10 years). “Accordingly, characterization of long-term outcomes in acute lymphoblastic leukemia patients who remain in first complete remission for at least a decade has assumed increasing importance, especially in view of the long life expectancy of this survivor population.” But little is known about the incidence of secondary tumors or cancer after 15 to 20 years in children and adolescents who were treated for acute lymphoblastic leukemia.

Nobuko Hijiya, M.D., of St. Jude Children’s Research Hospital, Memphis, Tenn., and colleagues conducted a study to estimate the long-term (30-year) cumulative incidence of secondary neoplasms (cancers) in 2,169 children and adolescents treated for acute lymphoblastic leukemia between 1962 and 1998 at St. Jude Children’s Research Hospital. The patients had achieved complete remission and had a median (mid-point) follow-up time of 18.7 years (range, 2.4 – 41.3 years).

The researchers found that among the 1,290 patients who remained in complete remission, 123 (9.5 percent) developed a secondary neoplasm as their first event. The cumulative incidence of secondary neoplasms in all patients as the first event after complete remission was 4.17 percent at 15 years, increasing to 5.37 percent at 20 years and to 10.85 percent at 30 years. “The relatively rapid increase in incidence at 20 years after complete remission can be attributed largely to the late development of meningiomas [a tumor near the brain and spinal cord] and basal cell carcinomas,” the authors write.

When meningiomas and basal cell carcinomas were excluded, the overall cumulative incidence was 3.99 percent at 15 years and 6.27 percent at 30 years, representing a 13.5-fold increase in overall risk compared with the general population.

The cumulative incidence of each tumor type at 30 years was 2.19 percent for myeloid (related to bone marrow) malignancy, 0.17 percent for lymphoma, 3.00 percent for brain tumor, 4.91 percent for carcinoma, and 0.57 percent for sarcoma.

“In conclusion, the cumulative incidence of secondary neoplasm after treatment for childhood acute lymphoblastic leukemia does not attain a plateau at 15 to 20 years but continues to increase over 30 years. Although the majority of these late-occurring secondary neoplasms are low-grade tumors such as meningioma and basal cell carcinoma, the health care issues they raise may be critical. The risk for high-grade tumors, especially carcinomas, significantly exceeds the risk in the general population, underscoring the need for continued careful follow-up of acute lymphoblastic leukemia survivors,” the authors write.

(JAMA. 2007;297:1207-1215)

This work was supported in part by grants from the National Institutes of Health and by the American Lebanese Syrian Associated Charities. Co-author Ching-Hon Pui, M.D., is an American Cancer Society professor. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: St. Jude Public Relations
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New research shows that individual exacerbations in chronic obstructive lung disease (COPD) themselves increase the likelihood of repeat exacerbations, even after five days of full, asymptomatic recovery – bad news for patients with COPD, where each exacerbation can drive the progression of the disease.

“This concept that exacerbations are not random has important implication for the analysis of clinical trial data and identifies a specific high-risk period for recurrent exacerbation during which preventative interventions might be targeted,” wrote lead author, John Hurst, M.D., of the Royal Free and University College Medical School, in London.

The results appeared in the first issue for March of the American Journal of Respiratory and Critical Care Medicine, a publication of the American Thoracic Society.

In patients with COPD, exacerbations are generally defined as an acute worsening of symptoms. Exacerbations in and of themselves are inherently dangerous and can lead to hospitalization and serious complications. But beyond their acute dangers, exacerbations drive lung function decline, and many patients never recover their baseline level of lung function after exacerbations. Prior to this research, however, exacerbations were assumed to be isolated events unrelated to one another despite observational data that suggested a dependency.

To test the validity of this assumption, which not only informs treatment plans for patients with COPD, but also forms the basis of research design and analysis, Dr. Hurst and colleagues analyzed daily symptom diaries that were kept for at least one year by 297 COPD patients, describing nearly 2,000 distinct exacerbation events. Two or more new or worsening symptoms, one of which must be “major” (e.g., dyspnea, more sputum, or a change in color of sputum) constituted an exacerbation, and after five days of symptoms reverting to baseline severity, the exacerbation was considered to be over. A second exacerbation occurring within an eight-week period was considered to be a recurrent exacerbation. The researchers further analyzed seasonality of exacerbations, comparing their winter (November to January) frequency with their summer (June-August) frequency.

In addition to the finding that exacerbations were clustered in time within individuals, the researchers found that they were significantly more common in the winter than the summer. They also noted that “isolated” exacerbations tended on average to be about 25 percent more severe than the first of serial exacerbations.

But most importantly, the researchers identified an eight-week period of time during which monitoring and follow-up is crucial to prevent or minimize further exacerbations in the COPD patient. “Our finding of a high-risk period for recurrent exacerbation may be important in guiding patient follow-up,” wrote Dr. Hurst.

“The mechanisms of exacerbation recurrence remain unexplored, and it is unknown whether recurrence is due to persistence of an existing organism or to acquisition of a new one,” noted Dr. Hurst. However, there are some clues that may guide future research. “The failure to eradicate bacteria with exacerbation therapy has been associated with an incomplete recovery in inflammatory markers and we have recently reported a relationship between elevated C-reactive protein during the recovery period of an initial exacerbation and shorter time to the next.” Furthermore, the paper noted that “symptoms more typical of viral infection are significantly more common during isolated events.”

“This knowledge is very important for physicians,” wrote Shawn D. Aaron, M.D., of the Ottawa Health Research Institute, in Canada, in an editorial in the same issue of the journal. “Clinicians should now be aware that their patients with COPD who experience an exacerbation may be particularly ‘brittle’ during a subsequent eight-week period. Close monitoring and follow-up during this time would hopefully lead to earlier therapy for recurrent exacerbations that may improve clinical outcomes.”

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By joining a sugar to a short-chain fatty acid compound, Johns Hopkins researchers have developed a two-pronged molecular weapon that kills cancer cells in lab tests. The researchers cautioned that their double-punch molecule, described in the journal Chemistry & Biology, has not yet been tested on animals or humans. Nevertheless, they believe it represents a promising new strategy for fighting the deadly disease.

“For a long time, cancer researchers did not pay much attention to the use of sugars in fighting cancer,” said Gopalan Sampathkumar, a postdoctoral fellow in the university’s Department of Biomedical Engineering and lead author of the journal article. “But we found that when the right sugar is matched with the right chemical partner, it can deliver a powerful double-whammy against cancer cells.”

Sampathkumar and his colleagues built upon 20-year-old findings that a short-chain fatty acid called butyrate can slow the spread of cancer cells. In the 1980s, researchers discovered that butyrate, which is formed naturally at high levels in the digestive system by symbiotic bacteria that feed on fiber, can restore healthy cell functioning.

Efforts to use butyrate as a general drug for tumors elsewhere in the body, however, have been hindered by the high doses of the compound needed to effectively eradicate cancer. To get around this problem, scientists have tried to make butyrate more potent by modifying it or joining it to other compounds. Usually, the results have been disappointing because the molecular partner added to butyrate to improve delivery to the cancer cells often produced unsafe side effects.

In some of the less successful experiments, designed to avoid toxic side effects, researchers used innocuous sugar molecules such as glucose to carry butyrate into the cells. The Johns Hopkins team tried a different tack. “We didn’t think they chose the right partner molecule,” said Kevin J. Yarema, an assistant professor of biomedical engineering who supervised the project. “Our insight was to select the sugar partner to serve not just as a passive carrier but as additional ammunition in the fight against cancer.”

The researchers focused on a sugar called N-acetyl-D-mannosamine, or ManNAc, for short. The team created a hybrid molecule by linking ManNAc with butyrate. The hybrid easily penetrates a cell’s surface, then is split apart by enzymes inside the cell. Once inside the cell, ManNAc is processed into another sugar known as sialic acid that plays key roles in cancer biology, while butyrate orchestrates the expression of genes responsible for halting the uncontrolled growth of cancer cells.

Although the study of the exact molecular mechanism is in its early stages, the researchers believe the separate chemical components work together to bolster the cancer-fighting power of butyrate. The double attack triggers cellular suicide, also called apoptosis, in the cancer cells.

To find out whether this butyrate-ManNAc hybrid alone would produce the positive results, the researchers tested three other sugar-butyrate combinations and a butyrate salt compound with no sugar attached. The four other formulas and the butyrate-ManNAc hybrid were each added to lab dishes containing cancer cells. After three to five days, cancer growth had slowed in all of the dishes. After 15 days, however, cancer growth had resumed in dishes treated with four of the compounds. But in samples treated with the butyrate-ManNAc hybrid, all of the cancer cells had died.

The researchers also wanted to find out whether administering the two parts of the hybrid independently would achieve the same result. But in these experiments, the cancer cells did not self-destruct. The researchers suspect this is because the hybrid molecules more easily penetrate the surface of the cell than the individual chemicals. Once the components are inside, the researchers believe the partners help enzymes to resume the normal assembly of sugar molecules and correct aberrant gene expression patterns, two processes that go awry when cancer occurs.

Now that they’ve identified the butyrate-ManNAc molecule as a potential cancer fighter, the Johns Hopkins team members are expanding their research, looking for new drug-delivery methods and preparing for animal testing. The researchers believe the hybrid molecule will have minimal effect on healthy cells. Through the Johns Hopkins Technology Transfer Office, they have filed an application for a U.S. patent covering this class of compounds.

Along with Sampathkumar and Yarema, the co-authors of the journal article included several past and present Johns Hopkins students: Mark B. Jones, M. Adam Meledeo, Christopher T. Campbell, Sean S. Choi, Kaoru Hida, Prasra Gomutputra and Anthony Sheh. Other co-authors were Tim Gilmartin and Steven R. Head, both of the DNA Microarray Facility of the Consortium for Functional Glycomics at the Scripps Research Institute in La Jolla, Calif.

Funding for this research was provided by the Arnold and Mabel Beckman Foundation, the National Institutes of Health and the National Science Foundation.

Related Links: Johns Hopkins Department of Biomedical Engineering: bme.jhu/

Functional Glycomics Gateway: functionalglycomics/

Contact: Phil Sneiderman

Johns Hopkins University Continue reading →

Bicuspid Aortic Valve (BAV), a condition in which patients’ aortic valves have just two leaflets instead of the normal three, is the most common cardiac anomaly, affecting up to two percent of the general population. The defect can result in calcification deposits on the heart valve, leakage of the valve and may results in a feeling of tightness in the chest as well as shortness of breath. The condition is easily diagnosed; often physicians can hear a “click” or a murmur when they listen to a BAV patient’s heart with a stethoscope.

Studies have shown that BAV is likely genetic, although the gene has not been identified, and in some families, incidence of this defect could run as high as 20 percent.

A new study, published in the Journal of the American College of Cardiology, suggests that nearly a third of first-degree relatives (siblings, children or parents) of BAV patients are likely to have enlarged aortas, a potentially serious condition that can only be detected by undergoing transthoracic echocardiograms. This was found even in the absence of any abnormalities of the heart valve itself.

According to the study, 32 percent of first-degree relatives with no heart valve abnormality had significantly larger aortas that expected for age, gender and body size as compared to no enlargement seen in control patients. Also, the study found that the aortas of the first-degree relatives had abnormal stiffness similar to the patients with congenital bicuspid valve. Generally, when aortas are 50 millimeters in diameter, surgery is recommended in order to prevent a rupture of the aorta.

“If you know that a relative does have bicuspid aortic valve, then you know that you should be screened,” said study author Kirsten Tolstrup, MD, assistant director of the Cardiac Noninvasive Laboratory at the Cedars-Sinai Heart Institute. “BAV appears to be a genetic condition that has many different manifestations, so we will be studying the genes.”

Kirsten Tolstup, MD, assistant director of the Cardiac Noninvasive Laboratory at the Cedars-Sinai Heart Institute, is available to discuss the study’s findings and provide additional details.

This study, conducted among 54 patients with bicuspid aortic valve and 48 first-degree relatives of those patients as well as 45 matched controls found:
32 percent of apparently healthy first-degree relatives have enlarged aortas

53 percent of BAV patients had enlarged aortas

9.4 percent of first-degree relatives had BAV

The findings suggest that patients with bicuspid aortic valve and their first-degree relatives should have a screening echocardiogram to be evaluated for dilated aorta and bicuspid aortic valve.

Citation: Journal of the American College of Cardiology, June 8, 2009, “Aortapathy is Prevalent in Relatives of Bicuspid Aortic Valve Patients”

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The American Society of Clinical Oncology (ASCO) is expanding its tools to improve documentation and coordination of cancer treatment and survivorship care by developing a chemotherapy treatment plan and summary template for breast cancer patients.

Cancer is the number-one disease killer for people under age 85 in the United States. In 2007, more than 178,480 women in the United States will be diagnosed with breast cancer, and more than 40,460 women will die from the disease. The goal of the breast cancer treatment plan and summary (available at asco/treatmentsummary) is to improve communication among oncologists, patients and other care providers to better manage breast cancer patients’ treatment across health care settings. It will also make gathering data to evaluate and improve quality of care and patient outcomes more accurate and efficient.

The new breast cancer treatment plan and summary template joins a colorectal treatment template published online earlier this year. ASCO is continuing to develop and test treatment plans and summaries for additional cancer diagnoses, including lung cancer.

The chemotherapy treatment plan, which the oncologist is to fill out before the patient begins receiving chemotherapy, maps out the patient’s planned treatment. The treatment summary, developed after treatment is complete, describes what care the patient actually received. Some of the core elements of the treatment plan and summary include:

- Diagnosis, including the cancer site, histology and stage
- A summary of the chemotherapy and other treatment that is planned and actually delivered
- The reason treatment was stopped or modified
- Information on appropriate follow-up care and relevant providers
- Evidence-based survivorship and surveillance guidelines from ASCO

Since 1990, the number of women who have died of breast cancer has declined steadily each year. To improve care for the increasing number of cancer survivors, ASCO developed the Breast Cancer Survivorship Plan that can be added to the treatment summary to provide clarification on necessary follow-up care, including physical exams, post-treatment mammography, breast self-examination, and pelvic examinations.

“The adjuvant treatment plan and summaries and the breast cancer survivorship plan are not only tools for oncologists, but also an educational resource for patients,” said Patricia Ganz, MD, professor of health services and medicine at the UCLA School of Public Health and director of the Division of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center. “We expect that discussion of the plan with the patient, and sharing of the information with her primary care provider, will improve coordination of follow-up care after primary breast cancer treatment.”

The breast cancer treatment plan and summary have been field tested by practices, Dr. Ganz added, to ensure that the most useful information is being tracked and patients are consistently receiving quality care. All ASCO treatment plan and summary templates are published in modifiable forms, allowing oncologists to customize and adapt them to suit their own practices.

ASCO also is promoting integration of the treatment plan and summaries into oncology electronic health records (EHRs). “After Hurricane Katrina, the need for durable, transportable medical records became increasingly obvious,” said ASCO President Nancy Davidson, MD, director of the Breast Cancer Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland.

“Cancer patients in particular need to have access to their medical records,” Dr. Davidson added. “ASCO developed these templates as a standard for an oncology patient’s EHR. It would be very complicated if every oncology office is out there designing their own version of an EHR.”

The treatment plan and summary are not intended to replace detailed chart documentation, including complete patient histories or chemotherapy flow sheets. No single treatment plan can be appropriate for all patients; treating oncologists assume responsibility for tailoring the treatment summary to meet individual patient’s needs.

The American Society of Clinical Oncology (ASCO) is the world’s leading professional organization representing physicians of all oncology subspecialties who care for people with cancer. ASCO’s nearly 25,000 members from the United States and abroad set the standard for patient care and lead the efforts to discover more effective cancer treatments, increase funding for clinical and translational research, and, ultimately, improve cancer care for the estimated 10 million people diagnosed with cancer worldwide each year. ASCO publishes the Journal of Clinical Oncology (JCO), the preeminent, peer-reviewed, medical journal on clinical cancer research, and produces People Living With Cancer (PLWC), a comprehensive consumer Web site providing oncologist-vetted cancer information to help patients and families make informed health-care decisions.

American Society of Clinical Oncology Continue reading →

Data from multiple clinical trials of the world’s first pro-healing stent, OrbusNeich’s Genous Bio-engineered R stent, and preclinical data from Combo Bio-engineered Sirolimus Eluting Stent will be presented next week at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2009, in San Francisco.

Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam will provide the final 12-month outcomes from e-HEALING, a monitored, multi-center, worldwide (outside the United States) prospective registry with 5,000 enrolled patients. The oral presentation will take place at 1:16 p.m. PDT on Sept. 22 in room 104 at the Moscone Center.

In addition, de Winter and his colleagues will present a poster titled “Patients with diabetes mellitus in the worldwide e-HEALING registry have a low target lesion revascularization rate at 12-month follow-up.” The poster can be reviewed from 8 a.m. PDT – 10 p.m. PDT on Sept. 22 in Hall D.

An additional poster titled “Routine use of an EPC-capturing stent in patients undergoing primary PCI for ST-segment elevation myocardial infarction: A prospective registry in all comers,” will be presented by Jan-Henk Dambrink, M.D., Ph.D., of the Isala klieniken, Zwolle, Netherlands, and can be reviewed from 8 a.m. PDT – 10 p.m. PDT on Sept. 22 in Hall D.

Juan F Granada, M.D., medical director of the Skirball Center for Cardiovascular Research and assistant professor at Columbia University, New York, will present preclinical data of OrbusNeich’s Combo Bio-engineered Sirolimus Eluting Stent, which is designed to combine the pro-healing technology used in OrbusNeich’s Genous Bio-engineered R stent for rapid endothelial coverage and improved functionality with abluminal sirolimus sustained drug elution for the control of neointimal proliferation. The oral presentation titled “The OrbusNeich EPC-Coated Bioabsorbable Polymer Sirolimus-Eluting Stent Program” will take place at 2:31 p.m. PDT on Sept. 22 in room 104.

About Genous

Genous is OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the placement of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

OrbusNeich’s Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world’s first pro-healing stent, the Genous Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China.

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Allos Therapeutics, Inc (NASDAQ: ALTH) today announced that it has acquired an exclusive worldwide license from the
University of Colorado Health Sciences Center, the University of Salford and Cancer Research Technology to develop and
commercialize a new chemotherapeutic agent known as RH1. The compound is currently being investigated in a Phase 1 clinical
trial sponsored by Cancer Research UK, the largest volunteer-supported cancer research organization in the world.

RH1 is a targeted cytotoxic prodrug that is bioactivated by the enzyme DT-diaphorase (DTD), which is over-expressed in many
tumors relative to normal tissue, including lung, colon, breast and liver tumors. The drug exhibits a similar mechanism of
action to the potent chemotherapeutic agent Mitomycin C, with greater potential activity against cells expressing high DTD
and a potentially more favorable safety profile. RH1 was a nominated compound for advancement in the National Cancer
Institute’s Developmental Therapeutics Program (DTP), which provides cancer drug discovery and development resources to the
intramural, academic and industrial research communities.

“Pre-clinical work has shown RH1 to be a more efficient substrate for DTD than currently available agents, “said Dr. David
Ross, Professor of Toxicology and Chairman, Dept. of Pharmaceutical Sciences at the University of Colorado. “This drug may
offer a means to selectively target tumors expressing high levels of DTD.”

RH1 is currently being evaluated in patients with advanced solid tumors refractory to other chemotherapy regimens in an open
label, Phase 1 dose escalation study chaired by Dr. Malcolm Ranson, Director Derek Crowther Unit, Christie Hospital,
Manchester, UK. Up to 40 patients will be enrolled to test the safety, tolerability and pharmacokinetics (PK) of escalating
doses of RH1. Patient DTD enzyme levels are being measured to correlate with drug efficacy. Recruitment began in September
2003 and is expected to complete in the second half of 2005.

“We’ve enrolled nearly a third of the desired number of patients for the study and are encouraged by results seen to date
from both a safety and efficacy standpoint,” said Dr. Ranson.”

Under the terms of the agreement, Allos will make an up-front payment and a series of milestone payments based upon the
achievement of specified development, regulatory and commercialization goals. Allos will also make royalty payments based on
product sales, if any, resulting from the collaboration. Cancer Research UK will continue to support the ongoing Phase 1 dose
escalation study, and Allos will have the right to obtain an exclusive license to the results of the study, for use in
subsequent development and regulatory activities, upon payment of a one-time data option fee. Upon completion of the Phase 1
study, Allos will assume responsibility for all further development costs and activities. Financial terms of the transaction
were not disclosed. However, Allos does not expect the in-licensing of RH1 to result in a material increase in its quarterly
operating expenses for at least the next 18-24 months.

“We’re excited to add this novel compound to our growing oncology portfolio,” said Michael E. Hart, President and Chief
Executive Officer of Allos. “RH1 complements our current development programs and will allow us to capitalize on our in-house
clinical, regulatory and manufacturing expertise.”

About Allos Therapeutics, Inc.

Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for
improving cancer treatments. The company’s lead clinical candidate, EFAPROXYN (efaproxiral), is a synthetic small molecule
that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and enhance the efficacy of standard radiation
therapy. In addition, Allos is developing PDX (pralatrexate), a novel small molecule cytoxic injectable antifolate (DHFR
inhibitor) intended to treat non-small cell lung cancer, mesothelioma and non Hodgkin’s lymphoma. For more information,
please visit the company’s web site at: allos.

Safe Harbor Statement

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning the potential safety
and efficacy profile of RH1; the projected enrollment and timeline for completion of the ongoing Phase 1 dose escalation
study; the projected impact of RH1 on the Company’s quarterly operating expenses; and other statements that are other than
statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “intends,” “plans,” anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,”
“continue,” and other similar terminology or the negative of these terms, but their absence does not mean that a particular
statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to
risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking
statements. These risks and uncertainties include, among others: that clinical trials may not demonstrate that RH1 is both
safe and more effective than current standards of care; that the Company may be unable obtain the regulatory approvals
necessary to conduct additional clinical trials; that the Company and/or its collaborators may not be able to enroll
sufficient numbers of patients in their clinical trials; that data from preclinical studies and clinical trials may not
necessarily be indicative of future clinical trial results; that the safety and/or efficacy results of clinical trials for
RH1 will not support an application for marketing approval in the United States or any other country; and the risk that the
Company may lack the financial resources and access to capital to fund future clinical trials for RH1 or any of its other
product candidates. Additional information concerning these and other factors that may cause actual results to differ
materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the
Company’s Annual Report on Form 10-K for the year ended December 31, 2003, as amended, and in the Company’s other periodic
reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter
ended September 30, 2004. The Company cautions investors not to place undue reliance on the forward-looking statements
contained in this press release. All forward-looking statements are based on information currently available to the Company
on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect
events or circumstances after the date of this presentation, except as required by law.

Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc.

Contact:
Jennifer Neiman
Manager, Corporate Communications
Allos Therapeutics
720-540-5227
jneimanallos
allos Continue reading →

Despite a
mandatory program designed to prevent pregnant women from being exposed to
the anti-acne medication Accutane and similar medications containing
isotretinoin (a known teratogen or birth defect-causing agent), 122
pregnancies were exposed during the first year of the program, known as
iPledge, a report revealed.

The March of Dimes Foundation said it is evaluating the report and will
carefully review any proposed changes to the program following the meeting
tomorrow of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee
and Drug Safety and Risk Management Advisory Committee.

“It’s certainly a positive step that FDA and the drug manufacturers
have made this information publicly available, so that the iPledge program
can be properly evaluated,” said Michael Katz, M.D., senior vice president
for Research and Global Programs of the March of Dimes. “Although no human
system will ever be perfect, the goal is to prevent birth defects to the
fullest extent possible. No woman should ever take isotretinoin while
pregnant and no woman should get pregnant while taking isotretinoin. Too
many pregnancies still are being exposed to this drug.”

Recently, the FDA said it took steps to close a loophole in the iPledge
program by warning women not to buy Accutane, or any generic forms of the
drug, over the Internet, to bypass the monitoring program.

Isotretinoin, one of the most potent teratogens, is marketed under
several brand names to treat severe acne that does not respond to
conventional treatments. More than 1.5 million prescriptions were written
annually according to 2001-2002 FDA data.

Isotretinoin is chemically related to vitamin A. Birth defects
associated with isotretinoin include mental retardation, brain and heart
defects. Birth defects or miscarriages can occur soon after conception,
often before a woman realizes she is pregnant.

The iPledge program is administered by Covance, a company designated by
the drug manufacturers and required to report to the FDA. It was modeled on
the program created in 1998 to monitor and control the use of Thalomid
(thalidomide).

The March of Dimes works to improve the health of babies by preventing
birth defects, premature birth and infant mortality.

March of Dimes
marchofdimes

View drug information on Thalomid. Continue reading →

MIV Therapeutics, Inc.
(OTCBB: MIVI) (FRANKFURT: MIVN), a leading developer of
next-generation coatings and advanced drug-delivery systems for
cardiovascular stents and other implantable medical devices,
announced that the Journal of the American College of Cardiology
Intervention (JACC Intervention) published preliminary results from
the VESTASYNC I trial. The peer-reviewed article titled “Preliminary
Results of the Hydroxyapatite Non-Polymer-Based Sirolimus-Eluting
Stent for the Treatment of Single De Novo Coronary Lesions – A
First-In-Human Analysis of a Third Generation Drug-Eluting Stent
(DES) System” appears in the October 21st edition of JACC and is
available online at interventions.onlinejacc.

Dr. Mark Landy, MIV President and Chief Executive Officer, said, “The
publication of the preliminary VESTASYNC I trial results in such a
prestigious, peer-reviewed journal as JACC is clearly a vote of
confidence in the soundness of our science. We are very proud to be
included and to receive this tremendous recognition by the scientific
community.”

The article, authored by J. Ribamar Costa, Jr., M.D. et al.,
describes the positive results from the four-month follow-up of a
multicenter, 15-patient, First-In-Man study led by principal
investigator Alexandre Abizaid, M.D., Ph.D., Chief of Coronary
Intervention of Institute Dante Pazzanese of Cardiology in Sao Paulo,
Brazil. The VESTAsync(TM) drug-eluting stent was successfully
implanted in all cases, and there were no procedure and in-hospital
complications. Life-long aspirin and five-month clopidogrel therapy
were prescribed for all patients. At four months, in-stent late lumen
loss was 0.30 +/- 0.25 mm and percent of stent obstruction was 2.8
+/- 2.2%. The VESTAsync(TM) drug-eluting stent late loss of 0.30 mm
situates this new device among the highest-efficacy DES, with the
advantage of a polymer-free system using less drug than
first-generation equivalents. After up to six months of clinical
follow-up, no major adverse cardiac events were registered.

At the Transcatheter Cardiovascular Therapeutics (TCT) conference
last year in October 2007, Dr. Abizaid presented four-month follow-up
efficacy data on 13 patients in the 15-patient study. The Company
has since reported excellent data at 12-months clinical follow up on
all 15 patients.

MIV Therapeutics is currently in a pivotal trial for VESTAsync(TM),
the company’s polymer-free drug-eluting stent. The VESTASYNC II trial
is a 120 randomized controlled study designed to demonstrate the
safety and efficacy of the VESTAsync(TM) where patients are given
anti-platelet medication (Plavix) for only three months. The current
anti-platelet standard is a minimum duration of one year and in many
cases is life-long therapy.

About MIV Therapeutics

MIV Therapeutics is developing a next-generation line of advanced
biocompatible coatings for passive and drug-eluting applications on
cardiovascular stents, as well as for a broad range of other
implantable medical devices. The Company’s ultra-thin coating
formulation is designed to protect surrounding tissue from
potentially harmful interactions with bare metallic stents. This
coating platform is derived from hydroxyapatite (HAp), an organic
material that has demonstrated excellent in vivo safety and
biocompatibility. Hydroxyapatite is a porous material that makes up
the bone mineral and matrix of teeth, and is widely used today as a
bone substitute material and for coatings on implantable fixation
devices in orthopedic, dental and other applications. The Company’s
novel polymer-free drug-eluting technologies based on HAp could also
provide an attractive alternative to current polymer-based
drug-eluting coatings on the stent market, which have been associated
with undesirable effects. The Company’s drug-eluting coatings are
additionally designed to suit a broad range of implantable medical
devices that could benefit from highly customizable drug release
profiles. MIV Therapeutics has a Collaborative Research Agreement
with the University of British Columbia and has received a government
grant for its research program on the “Development of Novel Drug
Eluting Composite Coatings for Cardiovascular Stents,” under the
National Research Council-Industrial Research Assistance Program.
Under this sponsorship, the Company is expected to complete its
drug-eluting research and development program and to reach product
commercialization. MIV’s intellectual property portfolio includes
patents held by the University of British Columbia and exclusively
licensed to MIV. Key patent applications filed simultaneously in
various countries around the world further protect the commercial
exclusivity of MIV’s inventions in the global marketplace. For more
information, please visit mivtherapeutics.

Forward-Looking Statements

Except for the historical information contained herein, the matters
discussed in this press release are forward-looking statements. All
statements that discuss expectations and projections with respect to
future matters including, without limitation, statements relating to
the safety and efficacy of the Company’s product and the ability of
the Company’s product to rejuvenate the stent market are
forward-looking statements. Such statements are indicated by words or
phrases such as “proposed,” “expected,” “believe,” “will,”
“breakthrough,” “significant,” “indicated,” “feel,” “revolutionary,”
“should,” “ideal,” “extremely” and “excited.” These statements are
made under “Safe Harbor” provisions of the Private Securities
Litigation Reform Act of 1995. Actual results may differ materially
from those described in forward-looking statements and are subject to
risks and uncertainties including, without limitation, market
acceptance of the Company’s product, the ability of the Company to
raise sufficient funding and to continue to develop its various
business interests as presently contemplated, and other factors
identified in the Company’s filings with the Securities and Exchange
Commission including, without limitation, the Company’s annual report
on Form 10-K for the year ended May 31, 2007 and Forms 10-Q. The
Company expressly disclaims any obligation to update publicly or
otherwise revise these statements, whether as a result of new
information, future events or otherwise, except to the extent
required by law.

Source
Anthony L. Huston
MIV Therapeutics, Inc.

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