Human Genome
Sciences, Inc. (Nasdaq: HGSI) announced that it has completed the
enrollment and initial dosing of patients in a randomized Phase 2 trial of
HGS-ETR1 (mapatumumab) in combination with the chemotherapy agents
paclitaxel and carboplatin as first-line therapy in advanced non-small cell
lung cancer (NSCLC).

“There is an urgent medical need for effective treatment options for
non- small cell lung cancer because current treatment strategies have only
a minimal impact on survival,” said Joachim von Pawel, M.D., a principal
investigator in the study from the Asklepios Fachkliniken Munchen-Gauting,
Germany. “The majority of patients who are newly diagnosed with non-small
cell lung cancer have locally advanced or metastatic disease that is
currently incurable. We look forward to evaluating the potential of
mapatumumab plus chemotherapy to offer a new approach to the first-line
treatment of this deadly disease.”

The NSCLC trial is a randomized, multi-center, open-label Phase 2 study
to evaluate the efficacy and safety of HGS-ETR1 in combination with
carboplatin and paclitaxel as first-line therapy in the treatment of
advanced non-small cell lung cancer (Stage IIIB or IV). 111 patients have
been randomly assigned to one of three treatment groups and treated with
either the two-agent combination of carboplatin and paclitaxel or the
three-agent combination of carboplatin, paclitaxel, and HGS-ETR1 at either
10 mg/kg or 30 mg/kg. HGS announced the initiation of the NSCLC trial In
December 2007.

“A growing body of preclinical data suggests that combining HGS-ETR1
with chemotherapy agents could be an effective approach to the treatment of
a number of malignancies, including non-small cell lung cancer,” said
Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research –
Oncology, HGS. “HGS-ETR1 is the most advanced of any product in development
that targets the TRAIL apoptotic pathway. The NSCLC study is one of three
ongoing HGS trials designed to evaluate combinations of HGS-ETR1 with
chemotherapeutic agents for the treatment of specific cancers.”

About the HGS-ETR1 Proof-of-Concept Trials

The HGS-ETR1 proof-of-concept phase includes three randomized trials to
evaluate its potential in combination with chemotherapy for the treatment
of specific cancers:

– Randomization and initial dosing of patients in the NSCLC study have
now been completed.

– In July 2008, HGS initiated dosing in the safety lead-in to a
randomized Phase 2 trial of HGS-ETR1 in combination with Nexavar
(sorafenib) in patients with advanced hepatocellular cancer, which accounts
for 80-90% of all liver cancers.

– The Company expects to have initial data available in the third
quarter of 2008 from a randomized Phase 2 trial of HGS-ETR1 in combination
with Velcade (bortezomib) in advanced multiple myeloma. Patients in the
multiple myeloma study will continue on treatment until the progression of
disease.

These three trials, taken together, will support a decision on whether
to advance HGS-ETR1 to Phase 3 development. It also is possible that a
sufficiently positive result from any one of the trials could lead to a
Phase 3 decision for that specific indication.

About Non-Small Cell Lung Cancer

Non-small cell lung cancer accounts for approximately 75-80% of all
lung cancers. It is estimated that more than 170,000 new cases and more
than 160,000 deaths occur annually in the United States alone. It is
currently the leading cause of cancer death in the U.S. in both men and
women.

About HGS-ETR1

HGS-ETR1 (mapatumumab) is an agonistic human monoclonal antibody that
directly induces cancer-cell death by specifically binding to and
activating the protein known as TRAIL receptor 1. Using genomic techniques,
HGS originally identified the TRAIL receptor 1 protein. The HGS-ETR1
antibody was generated by HGS through collaboration with Cambridge Antibody
Technology. HGS is developing HGS-ETR1 as a potential treatment for a broad
range of cancers.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to
bring innovative drugs to patients with unmet medical needs.

The HGS clinical development pipeline includes novel drugs to treat
hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated
diseases. The Company’s primary focus is rapid progress toward the
commercialization of its two key lead drugs, Albuferon(R) (albinterferon
alfa- 2b) for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase
3 clinical trials of both drugs are ongoing.

ABthrax(TM) (raxibacumab) is in late-stage development for the
treatment of inhalation anthrax, and the Company is on track to begin the
delivery in fall 2008 of 20,000 doses of ABthrax to the Strategic National
Stockpile under a contract entered into with the U.S. Government in June
2006. HGS also has three drugs in clinical development for the treatment of
cancer, including two TRAIL receptor antibodies and a small-molecule
antagonist of IAP (inhibitor of apoptosis) proteins. In addition, HGS has
substantial financial rights to certain products in the GSK clinical
development pipeline.

HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are
trademarks of Human Genome Sciences, Inc.

SAFE HARBOR STATEMENT

This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. The
forward-looking statements are based on Human Genome Sciences’ current
intent, belief and expectations. These statements are not guarantees of
future performance and are subject to certain risks and uncertainties that
are difficult to predict. Actual results may differ materially from these
forward-looking statements because of the Company’s unproven business
model, its dependence on new technologies, the uncertainty and timing of
clinical trials, the Company’s ability to develop and commercialize
products, its dependence on collaborators for services and revenue, its
substantial indebtedness and lease obligations, its changing requirements
and costs associated with facilities, intense competition, the uncertainty
of patent and intellectual property protection, the Company’s dependence on
key management and key suppliers, the uncertainty of regulation of
products, the impact of future alliances or transactions and other risks
described in the Company’s filings with the Securities and Exchange
Commission. In addition, the Company will continue to face risks related to
animal and human testing, to the manufacture of ABthrax and to FDA
concurrence that ABthrax meets the requirements of the ABthrax contract. If
the Company is unable to meet the product requirements associated with the
ABthrax contract, the U.S. government will not be required to reimburse the
Company for the costs incurred or to purchase any ABthrax doses, and we
will not receive any of the expected revenues relative to ABthrax. Existing
and prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of today’s date.
Human Genome Sciences undertakes no obligation to update or revise the
information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.

Human Genome Sciences, Inc
hgsi

View drug information on Nexavar; Velcade. Continue reading →

Last month, the BMJ reported a fall in the number of young women attending smear tests. Now, two senior doctors warn that a new policy not to screen women aged 20-24 may be a factor in falling coverage and could increase the risk of cancer developing in young women.

Prevalence of carcinoma in situ (a precursor to cancer known as CIN3) has increased in women aged 20-24, write consultants Amanda Herbert and John Smith. This new policy will add more than 3000 women with untreated CIN3 to the larger numbers failing to accept their invitations later on, they warn.

The authors accept that CIN may regress, that invasive cervical cancer (ICC) is rare in women under 25, and that screening does little to reduce its incidence in such young women. However, they argue that ICC can develop within a couple of years of missed cell analysis, failure to investigate cell abnormalities, or incomplete treatment, emphasising the importance of treating high-grade CIN when it is found.

Screening in the UK has been highly successful and, since 1988, incidence and mortality have fallen by more than 40% despite increased risk of disease. This has been achieved by treating high-grade CIN, particularly CIN3, in young women, say the authors. The peak prevalence of CIN3 is in women aged 25-29 amongst whom the fall in coverage has been greatest.

ICC is more difficult to prevent in young women because there are less screening opportunities to treat precancerous lesions before they become invasive, they add.

They believe that decisions about treatment of CIN should be based on a balance between risk of progression, likelihood of regression and risk of treatment. Women should be informed about the risk of high-grade CIN, its greater frequency in young women, the importance of surveillance, and the fact that an epidemic of cervical cancer has been prevented by screening women when they were young.

General practitioners and clinics should not be prevented from screening women whom they believe to be at risk if those women themselves want to be screened, they conclude.

Contact: Emma Dickinson

BMJ-British Medical Journal Continue reading →

Study highlights:
A stent that coats itself with the cells that line blood vessels is as effective as a drug-coated stent in preventing artery reblockage and blood clots for people with coronary artery disease.

Unlike drug-eluting stents, the new device requires only short-term antiplatelet therapy.

This stent is in use in many countries, but the Food and Drug Administration has not yet approved it for marketing in the United States.

A stent that entices artery-lining cells to coat it works as well or better than drug-eluting stents in keeping arteries open in coronary heart disease patients, according to two research studies presented at the American Heart Association’s Scientific Sessions 2008.

The new endothelial progenitor cell-capturing (EPC) stent is coated with an antibody that binds endothelial progenitor cells circulating in the blood. A number of smaller, randomized studies have shown that the stent is effective in carefully selected patients.

The new findings came from real-world patients who typically receive stents to restore adequate blood flow to the heart instead of carefully selected trial patients.

“Randomized trials have the advantage of a very good control group, but they usually have very restrictive exclusion and inclusion criteria; so results from randomized trials cannot be extrapolated to everyday patients,” said Sigmund Silber, M.D., chief of cardiology at M??ller Hospital Munich in Munich, Germany, and the first author of the large, multicenter stenting study.

In one study (abstract 6000), Silber and colleagues reported the one-year outcomes of 1,640 patients treated with the stent in an international study conducted outside the United States.

“The most significant finding was that the rate of stent blockage was really low,” Silber said. “The number of patients who needed another catheterized heart intervention within a year was also low.”
Patients were treated at 144 sites around the world and entered into an electronic registry. Their average age was 62.8 years, 78.7 percent were males, 25.0 percent had diabetes, and 36.7 percent had suffered a prior heart attack.

Based on results of previous studies, physicians pretreated 73.8 percent of the patients with statin drugs, which increase the number of endothelial progenitor cells in the blood.

Most patients received two anti-clotting drugs, generally aspirin and clopidogrel, for one month.

Researchers found that one year after stenting:
Only 1.0 percent of the patients suffered a stent-related blood clot.

2.1 percent of the patients died of cardiac causes; 1.8 percent of those were heart attacks.

5.4 percent required a revascularization procedure on the treated artery; a catheter-based procedure was used in 5.1 percent to restore blood flow.

9.3 percent experienced major adverse cardiac events (MACE), which included heart attacks, unexpected bypass surgery, treatment-related catheter-based revascularization, and cardiac death.

Among diabetic patients, 4.7 percent had undergone revascularization procedures, the MACE rate was 10.3 percent, and 1.1 percent had stent-related blood clots.

“The stent appears very safe, even in diabetics,” Silber said. “I don’t think EPC-capturing stents will replace drug-eluting stents, but whenever you decide not to use a drug-eluting stent, this stent is a good alternative.”

In a separate study (abstract 4491), researchers reported the one-year clinical outcome of 236 mainly high-risk patients treated with an EPC-capturing stent at the Academic Medical Center of the University of Amsterdam in The Netherlands.

Until recently, two types of stents were used in daily practice; the bare-metal stent and the drug-eluting stent. The latter is coated with an antiproliferative drug to reduce the risk of restenosis (reblockage).
“The long-term safety concerns of the drug-eluting stent are late stent thrombosis (stent-related blood clots) and an associated increased risk of bleeding, due to long-term dual antiplatelet therapy.” said Margo Klomp, M.D., first author of the Amsterdam study and a medical fellow at the Academic Medical Center.

In the single-center Dutch study, Klomp and her colleagues reported on patients with mainly complex lesions who were stented at the Amsterdam center between September 2005 and March 2007. The patients’ averaged 65 years old, 72 percent were male, and 14 percent had diabetes.

The researchers’ one-year follow-up findings included:
3.0 percent of the patients died, of whom 0.8 percent died of cardiac causes.

10.2 percent required a repeat revascularization procedure of the treated vessel.

1.2 percent (3 patients) had suffered stent thrombosis, which were angiographically documented and occurred within 24 hours, at seven days, and at 18 days, respectively.

The MACE rate, composed of cardiac death, target lesion revascularization and myocardial infarction, was 13.6 percent.

“Further research on the stent is being performed in a two-armed study, the TRIAS Program, at the Academic Medical Center,” Klomp said. “In one arm, TRIAS LR, the EPC-capturing stent is being compared with the bare-metal stent in patients with a low risk of develop a new blockage. In the other arm, TRIAS HR, the EPC-capturing stent is being compared with conventional drug-eluting stents in people with a high risk of restenosis.”

Co-authors with Silber in the international study are: Robbert de Winter, M.D., Ph.D.; Manfred Grisold, M.D.; Jaroslaw Wojcik, M.D.; Harry Suryapranata, M.D.; Expedito Ribeiro, M.D.; and Sim Kui Hian Sarawak, M.D.

OrbusNeich, maker of the EPC-capturing stent, funded the international study.

Co-authors with Klomp in the Dutch study are: Marcel A. Beijk, M.D.; Niels J. Verouden, M.D.; Karel T. Koch, M.D., Ph.D.; Jose P. Henriques, M.D., Ph.D.; Jan Baan, M.D.; Rene J. van der Schaaf, M.D.; Marije M. Vis, M.D.; Jan G. Tijssen, Ph.D.; Jan J. Piek, M.D., Ph.D.; and Robbert J. De Winter, M.D., Ph.D.
The Academic Medical Center funded the single-center Amsterdam study.

Individual author disclosures can be found on the abstract.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at americanheart/corporatefunding.

NR08-1128 (SS08/Silber and Klomp)

Continue reading →

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced that researchers who participated in the breast cancer arm of a Phase 3 clinical evaluation of Lymphoseek® presented data from their clinical experience at the International San Antonio Breast Cancer Symposium. The Phase 3 study referenced in the presentation was conducted in patients with either breast cancer or melanoma. The San Antonio presentation provided information on the breast cancer portion of the trial. Earlier this year, Neoprobe announced that the trial evaluated 130 procedure-compliant patients. The breast cancer arm of the trial contributed 60 patients.

The Phase 3 trial was designed to determine the accuracy of Lymphoseek to identify lymphatic tissue as compared to a commonly used vital blue dye. The primary objective of the Phase 3 trial was to obtain at least 203 lymph nodes identified with the vital blue dyes and to statistically demonstrate that 94% of those nodes were identified with Lymphoseek. The procedure-compliant patients contributed 215 vital blue dye positive lymph nodes and Lymphoseek identified 210 of those nodes for a success rate of 97%. In addition, Lymphoseek identified 85 lymph nodes that were missed by the vital blue dyes. Of those Lymphoseek-only positive nodes, 18% were found to contain tumor.

“We are very pleased by the positive audited data of the Phase 3 clinical trial for Lymphoseek in both breast cancer and melanoma patients,” said Dr. Frederick Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “The results of the Phase 3 trial have been provided to FDA and we believe if Lymphoseek is ultimately cleared for marketing that it will provide meaningful improvement in the treatment of cancer patients.”

Results of the breast cancer portion of the Phase 3 trial mirrored the overall results. The breast cancer patients provided 97 vital blue dye positive lymph nodes and 93 of those nodes were positive for Lymphoseek. The concordant detection rate of lymph nodes in breast cancer patients was 96%. In addition, Lymphoseek identified 49 lymph nodes in the breast cancer patients that were missed by the vital blue dyes. Of those Lymphoseek-only positive nodes, 10% were found by pathology to contain tumor. No drug-related adverse events were reported that were attributed to Lymphoseek.

Source
Neoprobe Continue reading →

A new study undertaken in Zambia shows that, using setting-appropriate human resources and technology, morbidity and mortality from cervical cancer among HIV-infected women can be reduced. The study’s lead author is
Dr Groesbeck Parham, Professor of Gynecologic Oncology and Infectious Diseases, University of Alabama at Birmingham, and Director of the Centre for Infectious Disease Research in Zambia’s Cervical Cancer Prevention Program. The research was published in the December issue of HIV Therapy.

More than half a million women are newly diagnosed with invasive cervical cancer (ICC) globally each year, and in the same period more than a quarter million die from the disease. In low-income regions, cervical cancer kills more women than any other malignancy. HIV-infected women without access to cervical cancer prevention services have a greater risk than uninfected individuals for persistent human papillomavirus (HPV) infections, cervical intraepithelial neoplasia (CIN), and invasive cervical cancer (ICC).

Unfortunately, in low-income nations like Zambia, less than 5% of women are ever screened for cervical cancer. However, one prevention method that has been extensively evaluated is visual inspection with dilute acetic acid (VIA) combined with same-visit treatment by cryotherapy. This screening method has been shown to be safe, acceptable, and clinically effective in reducing cervical cancer incidence and mortality.

The new study is the first to evaluate this approach in routine program implementation settings in the developing world. The authors launched the Zambian Cervical Cancer Prevention Program, which targeted HIV-infected women, with the ultimate goal of expansion to all Zambian women to decrease cervical cancer-associated morbidity and mortality. They systematically analysed the screening implementation efforts by measurement and modeling of the real world program effectiveness through measurement of outcomes of program uptake, screening test efficacy, and treatment effectiveness, and then extrapolation of its impact on mortality reductions.

Nurses undertook VIA screening aided by digital cervicography (photography). Women with visible lesions were offered same-visit cryotherapy or referred for histologic evaluation. Those with ICC were referred for surgery or radiation. Measures of clinical outcomes and modeled program effectiveness among HIV-infected women by estimating the total number of ICC deaths prevented through the screening and treatment efforts.

Between January 2006 to December 2008 21,010 women were screened for cervical cancer. Among the 31% (6,572) who were HIV-infected, 53.6% (3,523) had visible lesions, of whom 58.5% (2,062) were eligible for cryotherapy and 41.5% (1,461) were referred for histologic evaluation. 75% (1,095/1,462) of patients referred for histologic evaluation complied and underwent therapy. Pathology results from 65% (715/1,095) of women revealed benign abnormalities in 21% (151), CIN Grade 1 in 30% (214), CIN Grade 2/3 in 33% (235), and ICC in 16.1% (115). Of ICCs, 69% were early stage. Using a conditional probability model, the authors estimate that the program prevented 142 cervical cancer deaths (high/low range 238-96) in 6,572 HIV-infected women screened, or one cervical cancer death prevented per 46 (corresponding range: 28-68) HIV-infected women screened.

The authors state, “By using a setting-appropriate protocol for cervical cancer prevention, i.e., nurse-led visual screening and same-visit cryotherapy for eligible women, and linkage to a tertiary care centre for evaluation; our program has not just saved lives but has also established a new paradigm for routine prevention interventions in resource-constrained environments”.

The authors point out that these positive results show that concerted efforts and financial support for implementing cervical cancer prevention programs integrated within HIV/AIDS care programs are warranted. The claim that their prevention model can serve as the implementation platform for future low-cost HPV-based screening methods and that the results of the study may provide the basis for comparison of effectiveness of future prevention programs.

With respect to the effectiveness of the study, Dr Parham states, “The major outcome of the program was that while the screening method (VIA) has moderate effectiveness, because it was implementable it had a high intervention to impact ratio: for every 46 HIV-infected women that we screened we were able to prevent 1 death from cervical cancer. There are more effective tests than VIA, but they have not been adoptable in this setting. However effective a screening intervention, it will have no impact if it is not adoptable”.

Dr Parham goes onto to explain, “We started the program in the capital, Lusaka, and have now expanded to cover more rural areas. We recently had a meeting with the directors of provincial hospitals in the other provinces and in a couple of months we will start to roll out a national screening program under the leadership of the Zambian Ministry of Health”.

From such a low-tech ‘screen and treat’ program, the effectiveness results are very encouraging meriting national recognition and providing a model for expansion in other resource limited settings.

The full article is available here.

Notes

About HIV Therapy

HIV Therapy (formerly Future HIV Therapy) offers readily accessible analysis and guidance in key areas of HIV/AIDS research, offering researchers and professionals a forum for debate as the battle against HIV continues.

HIV Therapy covers:

- Optimal therapeutic approaches, including drug choice and treatment strategies

- Virus-host interactions

- Molecular basis of HIV infection

- Summaries evaluating newly approved anti-HIV agents

- Vaccine development, prevention measures and prophylaxis

- New and improved diagnostic methods

Continue reading →

Monogram
Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator
Pfizer Inc (NYSE: PFE) has reported results of a phase III study of its
investigational HIV medication, maraviroc, for treatment-naive adult
patients infected with CCR5-tropic HIV-1.

The data was reported by Pfizer at the International Aids Society
conference in Sydney, Australia. “Pfizer’s results indicate reduction in
viral load and increased CD4 counts,” said Christos Petropoulos, Monogram
Chief Scientific Officer. “In addition, the trial showed a safety profile
that was better than in the control arm. This further supports the safety
of maraviroc as a new treatment option for treatment-experienced patients.”

Monogram’s Trofile(TM) Assay has been used to select patients for all
of the drug’s clinical trials.

Pfizer has previously reported 24 week data from its phase III trials
of maraviroc in treatment-experienced patients and has recently announced
that the 48 week analysis has confirmed these 24 week findings. An NDA is
pending with the U.S. Food and Drug Administration and an approvable letter
has been received from the F.D.A. in respect of the use of maraviroc in
treatment- experienced patients. The data reported today by Pfizer is in
respect of a potential new indication in treatment-naive patients that
would be subject to a separate FDA submission.

About Monogram Biosciences, Inc.

Monogram is advancing individualized medicine by discovering,
developing and marketing innovative products to guide and improve treatment
of serious infectious diseases and cancer. The Company’s products are
designed to help doctors optimize treatment regimens for their patients
that lead to better outcomes and reduced costs. The Company’s technology is
also being used by numerous biopharmaceutical companies to develop new and
improved antiviral therapeutics and vaccines as well as targeted cancer
therapeutics. More information about the Company and its technology can be
found on its web site at monogrambio.

Forward-Looking Statements

Certain statements in this press release are forward-looking. These
forward-looking statements include references to the potential use of our
Trofile Assay as a molecular diagnostic for patient selection for Pfizer’s
CCR5 antagonist maraviroc, if approved by the FDA and European authorities,
and the potential approval of maraviroc for use in treatment-na??ve
patients. These forward-looking statements are subject to risks and
uncertainties and other factors, which may cause actual results to differ
materially from the anticipated results or other expectations expressed in
such forward-looking statements. These risks and uncertainties include, but
are not limited to: the risk that regulatory authorities may not require a
molecular diagnostic for patient selection for maraviroc; the risk that
maraviroc will not be approved by the FDA or European authorities for use
in treatment-experienced patients; the risk that Pfizer will not submit
marketing applications for use of maraviroc in treatment-na??ve patients and
that the FDA will not approve such marketing applications; risks related to
the implementation of the collaboration with Pfizer; risks associated with
establishing and maintaining logistics arrangements in European and other
non-U.S. markets for Trofile; risks and uncertainties relating to the
performance of our products; the growth in revenues and actual market
acceptance of our products; the impact of competition; whether payors will
authorize reimbursement for our Trofile; whether the FDA or any other
agency will decide to further regulate Trofile and our other products; the
ultimate validity and enforceability of our patent applications and
patents; the possible infringement of the intellectual property of others;
whether licenses to third party technology will be available; and whether
we will be able to raise sufficient capital in the future, if required. For
a discussion of other factors that may cause our actual events to differ
from those projected, please refer to our most recent annual report on Form
10-K and quarterly reports on Form 10-Q, as well as other subsequent
filings with the Securities and Exchange Commission. We do not undertake,
and specifically disclaim any obligation, to revise any forward-looking
statements to reflect the occurrence of anticipated or unanticipated events
or circumstances after the date of such statements.

Trofile is a trademark of Monogram Biosciences, Inc.

Monogram Biosciences, Inc.
monogrambio Continue reading →

A new testing method is being developed to detect cancer soon after the tumor has formed. It will identify characteristic substances in the blood which accompany a certain type of tumor. The first steps in the development have already been completed.

The earlier the doctor finds the tumor, the better the patient’s chances of recovery. A new testing method aims to detect the disease in its initial stages. The technology is based on a microfluidic chip with tiny channels in which a blood sample from the patient circulates. The chip traces marker proteins which are indicative of cancer. The measured concentration of the tumor marker in the blood will help doctors to diagnose the disease at an early stage. Similar testing systems already exist but their measurements are not very precise and they can only detect molecules that are present in the blood in large quantities. What’s more, the tests have to be carried out in a laboratory, which is time-consuming and costly.

A project funded by the German Ministry of Education and Research and coordinated by the Fraunhofer FIT aims to improve matters. Biofunctionalized nanoparticles developed by research scientists at the Fraunhofer Institute for Silicate Research ISC in W??rzburg are the key element in the new sensor. We have improved the detection limit compared with the present state of the art by a factor of one hundred, explains Dr. J?¶rn Probst, Head of the Business Unit Life Science at the ISC. ?»Whereas previously a hundred molecules were needed in a certain quantity of blood to detect tumor markers, we now need only one. This means that diseases can be diagnosed much earlier than with present methods.

But how does the biosensor integrated in the chip register the few biomolecules swimming around in the blood that are indicative of a certain disease? We have placed antibody-occupied nanoparticles on the sensor electrode which fish out the relevant proteins. For this purpose, we repeatedly pump the blood across the electrode surface. As with a river, the flow is fastest in mid-channel and the water runs more slowly near the bank. We have therefore made a sort of fishing rod using nanoparticles which registers the antibodies in the middle of the blood flow where most proteins swim by per unit of time. If an antibody catches the matching protein, a tumor marker, the electrical charge distribution shifts and this is picked up by the electrode.

The researcher groups are now developing a first demonstrator combining four independent single-molecule-sensitive biosensors. The experts are also working on the simultaneous detection of several tumor markers, which will increase the clarity of tests. The system will be ready to enter the market in a few years’ time.

Continue reading →

Pulmatrix Inc., a biotechnology company discovering and developing a broad new class of therapies for the treatment, prevention and transmission control of respiratory diseases, announced it will initiate a randomized, double-blind, placebo-controlled Phase 1b/2a clinical trial of its novel inhaled therapy, PUR003, to demonstrate its effectiveness, safety and tolerability in an experimental influenza challenge study. The study will begin in the third quarter of 2009.

Pulmatrix is developing novel, inhaled Cationic Airway Lining Modulator (iCALM) drugs, which stimulate host defense mechanisms within the airway to treat and prevent infection, independent of pathogen. These unique, dual mechanism therapies, delivered via an easy-to-use inhaled device, offer a truly novel approach that could fundamentally change the way respiratory diseases — particularly infectious respiratory diseases — are treated, prevented and controlled.

“We believe our iCALM therapies will fundamentally change how we address chronic and infectious respiratory diseases, particularly the flu,” said Robert Connelly, Chief Executive Officer, Pulmatrix. “The extremely encouraging Phase 1 results and preclinical data of PUR003 supports further clinical development, and we are moving aggressively to begin additional efficacy studies later this year.”

The Phase 1 double-blind, placebo-controlled, randomized study was completed in 2008 and designed to evaluate the safety and tolerability of single ascending doses of inhaled PUR003. The drug was found to be well tolerated at all doses evaluated with no serious adverse events reported. Furthermore, in preclinical studies, PUR003 produced significant treatment efficacy and demonstrated prophylaxis in multiple models of influenza, across different strains and in different animal species, including swine. These results were presented recently at the NIAID Influenza Antiviral Development Workshop.

“As evidenced by recent news, there is clearly a need for new therapies to treat and prevent the transmission of influenza,” said John P. Hanrahan, M.D., M.P.H., Chief Medical Officer and Senior Vice President, Pulmatrix. “Our iCALM therapies have demonstrated a meaningful impact on both the transmission and severity of infectious respiratory diseases in animals, and as such we believe they will offer breakthrough, practical solutions to treat and prevent human infection by airborne pathogens, including influenza.”

About PUR003

PUR003 is the lead drug candidate of Pulmatrix, and is an inhaled Cationic Airway Lining Modulator (iCALM) therapy designed to treat, prevent, and reduce transmission of a broad spectrum of airborne pathogens that pose community and public health risks. Pulmatrix expects to advance PUR003 into multiple clinical studies to demonstrate its utility in the treatment, prevention, and control of infectious and progressive respiratory diseases in 2009, including influenza. In a 2008 Phase 1 double-blind, placebo-controlled, randomized study designed to evaluate the safety and tolerability of single ascending doses of inhaled PUR003, the drug was found to be well tolerated at all doses with no serious adverse events reported. Furthermore, in preclinical studies, PUR003 demonstrated significant efficacy in the treatment and prophylaxis of influenza across multiple strains and in multiple species, including swine.

About Pulmatrix

Pulmatrix is discovering and developing a new class of inhaled therapies that treat, prevent, and help control respiratory diseases. These inhaled Cationic Airway Lining Modulator (iCALM) drugs stimulate host defense mechanisms that prevent infection and enhance the clearance of pathogens, and have the potential to address a wide range of significant medical needs through a novel pathogen independent approach. The Pulmatrix approach is based on the ground-breaking scientific work of renowned Harvard Professor David Edwards, and is financed by leading life science investors Polaris Venture Partners and 5AM Ventures. For additional information about the Company, please visit pulmatrix.

Source
Pulmatrix Continue reading →

A national clinical trial which opens imminently will aim to assess the impact of a novel anti-cancer drug in the setting of donor bone marrow transplantation for myeloma.

As part of this trial, investigative studies will be performed in the University of Leeds to determine the effect of this drug on the immune system recovery post bone marrow transplant and how this may relate to disease control.

The three year studies, funded by Yorkshire Cancer Research, will officially start next month at the university and test the drug Lenalidomide (Revlimid®) produced by global pharmaceutical company Celgene International S? rl. Lenalidomide is currently used under licence in the UK and internationally for myeloma patients who have not undergone a high-risk bone marrow transplant.

The Leeds studies will run parallel to the ongoing national clinical study and will specifically assess whether Lenalidomide is beneficial to the immune systems of multiple myeloma patients who have undergone a bone marrow transplant and are therefore at severe risk of contracting a life-threatening infection.

The laboratory studies are being conducted by
St James’s University Hospital and Leeds Institute of Molecular Medicine consultant haematologist Dr Gordon Cook and Clinical Scientist Dr Clive Carter.

The study ultimately aims to deliver a safer bone marrow transplant treatment strategy without affecting the usefulness of such a procedure for multiple myeloma cancer patients whose prognosis is limited.

Dr Cook said: “Recovery of the immune system after a donor bone marrow transplant is a highly complex process influenced by many key elements and sadly infection-related mortality still remains the main cause of death in the first 100 days after a bone marrow transplant.

“Simply put, we know that the success of donor stem cell transplantation in myeloma relates to the donor immune system attacking the tumour cells.

“So the trial has been set up to test a new drug, Lenalidomide (Revlimid) which has been found, through international phase three trials, to be effective at disease control in myeloma patients .

“Fundamentally, we will be testing this drug’s effect in myeloma patients who have specifically undergone a donor transplant to see if it increases recovery of their immune system whilst keeping the disease controlled in the same way it does those who haven’t undergone a transplant.

“Whilst data exists to describe the effect of Lenalidomide on the immune system the immunological effects of Lenalidomide in the context of myeloma patients undergoing a donor transplant have yet to be studied so this trial and these studies are crucial if we are to improve survival rates for all myeloma patients.”

The results of the Leeds studies will be added to the outcomes of the clinical trial (LenaRIC) into the drug in this setting.

Myeloma patients and bone marrow donors from right across the UK will take part in the dual trial and Leeds study by providing blood samples.

Yorkshire Cancer Research Liaison Officer, Dr Kathryn Scott said: “Yorkshire Cancer Research is excited to be funding this patient-centred cancer research and hopes are high that adding this new drug to the treatment plan for myeloma patients will reduce the chances of patients succumbing to an infection after a bone marrow transplant.

“Yorkshire Cancer Research is looking to supporting more of this kind of work to complement the very early stage laboratory studies that we currently fund in Yorkshire’s five universities.”

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Head and neck cancer patients who reported lower physical quality of life were more likely to die from their disease, according to a new study from the University of Michigan Comprehensive Cancer Center. The findings could mean that identifying patients with poor quality of life could also identify patients with particularly aggressive tumors.

“Low quality of life may have value in screening patients for recurrence. By identifying patients with poor quality of life, we may also be able to identify early on those who have particularly aggressive tumors,” says lead study author Carrie A. Karvonen-Gutierrez, M.P.H., research associate at the U-M School of Public Health and the VA Ann Arbor Healthcare System.

Results of the study appear in the June 1 issue of the Journal of Clinical Oncology.

The researchers surveyed 495 people at four hospitals who had been diagnosed with head and neck cancer within the previous two years. Participants responded to questions about physical and emotional quality of life, including pain, eating and swallowing, speech and emotional well-being.

The researchers found that general physical health and quality of life issues were highly associated with survival. And in particular, patients who reported difficulty with pain, eating and speech were significantly less likely to survive. The researchers suggest that pain and declines in other physical quality of life measures could be a marker for cancer recurrence.

“Our findings validate the concept that doctors have long recognized: that persistent or increasing pain is a worrisome clinical finding. Perhaps in the future, quality of life data will be routinely collected in a standardized way, and trends in pain scores will trigger more aggressive examinations for cancer recurrence,” says study author Sonia A. Duffy, Ph.D., R.N., a research scientist at the VA Ann Arbor Healthcare System, associate professor of nursing at the U-M School of Nursing and research assistant professor of otolaryngology at the U-M Medical School.

“While patients are monitored and screened after cancer treatment, small recurrences of cancer may be difficult to detect, even with standard imaging techniques. But, for example, small islands of cancer near a nerve can cause substantial pain before the cancer is detected on routine examination or imaging scans,” says study author Jeffrey Terrell, M.D., associate professor of otolaryngology at the U-M Medical School.

The next question for the researchers is to understand whether treatments that improve quality of life can improve survival.

“Although it is not yet clear how the association works between survival and quality of life related to head and neck pain, it is clearly advantageous to minimize pain for patients. And, if in doing that, the chance of cancer recurrence or patient survival is improved, the effort is worthwhile, regardless of why these factors are related. Patients want improved quality of life after cancer treatment – whether it be to improve survival or simply to improve everyday living and feel better,” Duffy says.

Based on their findings, the study authors recommend routine quality of life assessments of patients with head and neck cancer, before treatment and again after six months, one year and two years.

Additional study authors were David L. Ronis, Ph.D., associate research scientist at the U-M School of Nursing and research scientist at the VA Ann Arbor Healthcare System; Karen E. Fowler, research associate at the U-M Medical School and VA Ann Arbor Healthcare System; and Stephen B. Gruber, M.D., Ph.D., H. Marvin Pollard Professor of Internal Medicine at the U-M Medical School.

Funding for the study was from the Department of Veterans Affairs, GlaxoSmithKline through the Managed Care Forum, and the National Cancer Institute.

Reference: Journal of Clinical Oncology, Vol. 26, No. 16, June 1, 2008

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