Daily Health and Medicine News

Gout Treatment News

Savient Pharma 1Q loss widens on costs

Shares of Savient Pharmaceuticals Inc. slid Thursday after the company posted a wider quarterly loss that missed estimates, prompting an analyst to downgrade the stock.

Savient said its first-quarter loss widened on higher costs as the drugmaker prepared for the launch of its gout treatment Krystexxa.

The company lost $13.5 million, or 19 cents per share, compared with a loss of $8.3 million, or 13 cents per share, during the same period a year prior. Revenue rose 18 percent to $1.3 million from $1.1 million.

Analysts polled by FactSet expected a loss off 30 cents per share on $1.9 million in revenue.

The company reported $300,000 in revenue from Krystexxa. The company’s other drug is Oxandrin, which is used for weight gain following involuntary weight loss.

Operating costs jumped 81 percent to $20.8 million, mainly related to the launch of Krystexxa. In March, the company launched the drug, which is a treatment for adult patients with a type of chronic gout that doesn’t respond well to conventional therapy.

Shares of the company fell $2.04, or 18.4 percent, to $9.04 in afternoon trading and earlier traded at $8.77, its lowest point in 52 weeks. The stock has traded as high as $23.46 over the last year.

Leerink Swann Research analyst Joseph Schwartz downgraded shares to “Underperform” from “Market Perform” and lowered his price target to $4 from $9, saying the company may have overestimated the demand for Krystexxa.

He said the market opportunity for the drug in the U.S. is likely up to 60,000 patients instead of the hundreds of thousands the company expects. He lowered his annual sales estimate for the drug to $350 million from $500 million.

Regeneron Reports First Quarter 2011 Financial and Operating Results

VEGF Trap-Eye is a fusion protein locally administered in the eye that is designed to bind Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PlGF), proteins that are involved in the abnormal growth of new blood vessels. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare LLC has rights to market VEGF Trap-Eye outside the U.S., where the companies will share equally in profits from any future sales of VEGF Trap-Eye.

In February 2011, Regeneron submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). In April 2011, the FDA accepted the BLA for filing and granted the Company’s request for Priority Review. Under Priority Review, the target date for an FDA decision on the VEGF Trap-Eye BLA is August 20, 2011.

Also in February 2011, data from the Phase 3 VIEW 1 and VIEW 2 trials of VEGF Trap-Eye in patients with wet AMD and the Phase 3 COPERNICUS trial in macular edema due to central retinal vein occlusion (CRVO) were presented at the Bascom Palmer Eye Institute’s Angiogenesis, Exudation and Degeneration 2011 meeting. Results of the Phase 2 DA VINCI trial of VEGF Trap-Eye in diabetic macular edema (DME) were also presented.

In April 2011, Regeneron and Bayer HealthCare announced positive top-line results for VEGF Trap-Eye in the Phase 3 GALILEO study in patients with macular edema due to CRVO. The positive results from the GALILEO study confirmed the results of the similarly designed COPERNICUS study that were announced in December 2010. In GALILEO, the primary endpoint at week 24 was achieved: 60.2% of patients receiving 2 milligrams (mg) of VEGF Trap-Eye monthly gained at least 15 letters of vision from baseline, compared to 22.1% of patients receiving sham injections (p<0.0001). The key secondary endpoint of the study was also met: patients receiving 2 mg of VEGF Trap-Eye monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001). As in the COPERNICUS trial, VEGF Trap-Eye was generally well tolerated in the GALILEO study and the most common adverse events were those typically associated with intravitreal injections or the underlying disease. Serious ocular adverse events in the VEGF Trap-Eye group were 2.9% and were more frequent in the control group (8.8%). The most frequently reported adverse events overall in the VEGF Trap-Eye arm were eye pain, conjunctival hemorrhage, and elevated intraocular pressure. The most frequently reported adverse events in the control group were macular edema, eye irritation, and reduction of visual acuity. Detailed results of the GALILEO study will be presented at the EURETINA Congress in London in May 2011.

Based on these positive results, Regeneron intends to submit a regulatory application for marketing approval for VEGF Trap-Eye in CRVO in the U.S. in the second half of 2011, and Bayer HealthCare is planning to submit regulatory applications in Europe in 2012.

In April 2011, Regeneron and Bayer Healthcare announced that Bayer HealthCare has initiated the Phase 3 VIVID-DME study of VEGF Trap-Eye in DME in Australia. The trial will also be conducted in Europe and Japan. Regeneron intends to commence a second Phase 3 study (VISTA-DME) in DME later in 2011 in the U.S., Canada, and other countries.

ZALTRAP™ (aflibercept) – Oncology

ZALTRAP™, also known as VEGF Trap, is a fusion protein that is designed to bind VEGF-A, VEGF-B, and PlGF, proteins that are involved in the abnormal growth of new blood vessels in solid tumors. ZALTRAP™ is being developed worldwide by Regeneron and its collaborator, the sanofi-aventis Group, for the potential treatment of solid tumors.

In April 2011, Regeneron and sanofi-aventis announced that the Phase 3 VELOUR trial evaluating ZALTRAP™ in combination with the FOLFIRI chemotherapy regimen [folinic acid (leucovorin), 5-fluorouracil, and irinotecan] versus a regimen of FOLFIRI plus placebo met its primary endpoint of improving overall survival (OS) in the second-line treatment of metastatic colorectal cancer (mCRC). Full results will be presented at an upcoming medical meeting. The most frequent adverse events reported with ZALTRAP™ in combination with FOLFIRI were diarrhea, asthenia/fatigue, stomatitis and ulceration, nausea, infection, hypertension, gastrointestinal and abdominal pains, vomiting, decreased appetite, decreased weight, epistaxis, alopecia, and dysphonia.

Based upon these positive findings, Regeneron and sanofi-aventis plan to submit regulatory applications for marketing approval of ZALTRAP™ for the second-line treatment of mCRC to the FDA and the European Medicines Agency in the second half of 2011.

In February 2011, Regeneron and sanofi-aventis announced results from the Phase 3 VITAL trial evaluating ZALTRAP™ for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding ZALTRAP™ to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of ZALTRAP™ to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3% in the ZALTRAP™ arm compared to 8.9% in the placebo arm. The types and frequencies of adverse events reported in the ZALTRAP™ treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents. The most frequent Grade 3/4 adverse events included fatigue, stomatitis, disease progression, and hypertension.

Another randomized, double-blind Phase 3 trial (VENICE), which is fully enrolled, is evaluating ZALTRAP™ as a first-line treatment for metastatic, castration-resistant prostate cancer in combination with docetaxel/prednisone. Based on projected event rates, an interim analysis of the VENICE study is expected to be conducted by an Independent Data Monitoring Committee in mid-2011, and final results are anticipated in 2012.

In addition, a randomized Phase 2 study (AFFIRM) is evaluating ZALTRAP™ as a first-line treatment for metastatic colorectal cancer in combination with FOLFOX (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin). The AFFIRM study is fully enrolled, and initial data are anticipated in the second half of 2011.

ARCALYST® (rilonacept) – Gout

ARCALYST® is a fusion protein that blocks the cytokine interleukin-1 (IL-1). ARCALYST® is currently available for prescription in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. CAPS is a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.

In February 2011, Regeneron reported the results of its second and third Phase 3 studies of ARCALYST® in the prevention of gout flares in patients initiating uric acid-lowering therapy and announced that, based on these studies and a previously reported Phase 3 study, the Company plans to submit a supplemental BLA for U.S. regulatory approval of ARCALYST® in this setting in mid-2011. The Company reported that in the PRE-SURGE 2 efficacy study in gout patients initiating allopurinol therapy, ARCALYST® met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period. Patients who received ARCALYST® at a weekly, self-administered, subcutaneous dose of either 160 mg or 80 mg had a 72% decrease in mean number of gout flares compared to the placebo group (p<0.0001). These results were consistent with those in the identical Phase 3 efficacy study (PRE-SURGE 1) reported in June 2010. ARCALYST® was generally well tolerated with no reported drug-related serious adverse events. The most frequently reported adverse event was upper respiratory tract infection (15.5% with ARCALYST® 160 mg, 12.2% with ARCALYST® 80 mg, and 12.2% with placebo).

Regeneron also announced that in the third Phase 3 study (RE-SURGE), which evaluated the safety of ARCALYST® versus placebo over 16 weeks, ARCALYST® was generally well tolerated, and the safety profile was consistent with that reported in the PRE-SURGE 1 and PRE-SURGE 2 studies. RE-SURGE evaluated 1,315 patients who were at risk for gout flares while initiating or taking uric acid-lowering drug treatment. Other than injection site reactions, the incidence of treatment-emergent adverse events was generally well-balanced among the 985 patients who received ARCALYST® at a weekly, self-administered, subcutaneous dose of 160 mg and the 330 patients who received placebo. Injection site reactions, usually considered mild, were reported more commonly with ARCALYST® (15.2%) than with placebo (3.3%). Overall, the cumulative rate of infections was 20.1% in patients treated with ARCALYST® and 19.1% in placebo patients. Serious infections were reported in 0.5% of patients treated with ARCALYST® and 0.9% of placebo patients. Deaths were reported for 0.3% of patients treated with ARCALYST® and 0.9% of placebo patients.

In the RE-SURGE study, ARCALYST® also met all secondary endpoints, which evaluated efficacy, over the 16 week treatment period (p<0.0001). These included the number of gout flares per patient, the proportion of patients who experienced two or more flares, and the proportion of patients who experienced at least one gout flare during the study period.

Regeneron owns worldwide rights to ARCALYST®.

Monoclonal Antibodies

Since 2007, Regeneron and sanofi-aventis have collaborated on the discovery, development, and commercialization of fully human monoclonal antibodies generated by Regeneron using its VelocImmune® technology. During the fourth quarter of 2009, Regeneron and sanofi-aventis expanded and extended their collaboration with the objective to advance an average of four to five antibodies into clinical development each year between 2010 and 2017. The following eight antibody candidates are currently in clinical development under the collaboration:

REGN727, an antibody to Proprotein Convertase Substilisin/Kexin type 9 (PCSK9), a novel target for LDL cholesterol (“bad cholesterol”) reduction, has been evaluated in Phase 1 studies using both intravenous and subcutaneous routes of administration. REGN727 is being studied as a single agent and in combination with statin therapy. Phase 2 studies have been initiated in combination with statins in patients with hypercholesterolemia.

REGN88, an antibody to the interleukin-6 receptor (IL-6R), is in a Phase 2/3 study in rheumatoid arthritis and a Phase 2 study in ankylosing spondylitis, a form of arthritis that primarily affects the spine. Both studies are enrolling patients, and initial Phase 2 results are expected in mid-2011.

REGN421, an antibody to Delta-like ligand-4 (Dll4), a novel angiogenesis target, is in a Phase 1 study in patients with advanced malignancies.

REGN668, an antibody to the interleukin-4 receptor (IL-4R), a target for allergic and immune conditions, has completed Phase 1 testing in healthy volunteers. A Phase 1b study in patients with atopic dermatitis and a Phase 2 study in eosinophilic asthma are underway.

REGN910, an antibody to angiopoietin-2 (ANG2), a novel angiogenesis target, is in a Phase 1 study in an oncology setting.

REGN475, an antibody to nerve growth factor (NGF), has completed a Phase 2 trial in osteoarthritis of the knee. In December 2010, the Company was informed by the FDA that a case confirmed as avascular necrosis of a joint was seen in another company’s anti-NGF program. The FDA believes this case, which follows previously-reported cases of joint replacements in patients on an anti-NGF drug candidate being developed by another pharmaceutical company, provides evidence to suggest a class-effect and has placed REGN475 on clinical hold. There are currently no ongoing trials with REGN475 that are either enrolling or treating patients.

REGN728 and REGN846, whose targets remain undisclosed, have entered clinical development.

Financial Results

The Company’s total revenues increased to $112.2 million in the first quarter of 2011 from $103.5 million in the same quarter of 2010. The increases were primarily due to higher collaboration revenue in the first quarter of 2011 in connection with the Company’s antibody collaboration with sanofi-aventis.

Net product sales of ARCALYST® in the first quarter of 2011 were $4.4 million. Net product sales of ARCALYST® in the first quarter of 2010 were $9.9 million, which included $5.1 million of net product sales made during the quarter and $4.8 million of previously deferred net product sales.

The Company’s total operating expenses increased to $153.2 million in the first quarter of 2011 from $132.4 million in the same quarter of 2010. The increases were primarily due to higher research and development expenses arising from the Company’s expanding research and development activities in 2011 and related higher employee headcount, principally in connection with the sanofi-aventis antibody collaboration. Research and development expenses in the first quarter of 2011 rose to $129.4 million from $117.5 million in the same quarter of 2010.

The Company had a net loss of $43.4 million, or $0.49 per share (basic and diluted), for the first quarter of 2011 compared with a net loss of $30.5 million, or $0.38 per share (basic and diluted), for the first quarter of 2010.

At March 31, 2011, cash and marketable securities totaled $607.6 million (including $7.5 million of restricted cash and marketable securities) compared with $626.9 million (including $7.5 million of restricted cash and marketable securities) at December 31, 2010.

About Regeneron Pharmaceuticals

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.

This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s product candidates and research and clinical programs now underway or planned, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize its product and drug candidates, competing drugs that may be superior to Regeneron’s product and drug candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or terminated without any product success, and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2010 and Form 10-Q for the quarter ended March 31, 2011. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.

Savient Pharmaceuticals (SVNT) Finally Sells Kyrstexxa and Stops Auctioning Itself Off

Shares of small cap biotech Savient Pharmaceuticals (SVNT: Charts, News, Offers) have been trading near the lower end of its 52-week range of $9.06 to $23.46 despite the blockbuster potential of its chronic gout treatment, Kyrstexxa. Kyrstexxa is the first new gout treatment in four decades and a vast improvement over existing medications, treating a previously untreatable disease, and was approved by the FDA last year. The FDA granted Kyrstexxa an orphan status, which means that Savient’s drug will enjoy seven years of marketing exclusivity, being untouchable by biotech competitors and generic drug makers. This should be fantastic news for investors – stocks such as InterMune ITMN have skyrocketed overnight on similar prospects of locking up the market with an exclusive drug. InterMune shares in particular have more than tripled in five months on news that its exclusive idiopathic pulmonary fibrosis drug Esbriet had been approved by the European Union. So why has the market continuously punished Savient? Should new investors with a longer time frame with higher risk tolerance pick up shares in expectation of high sales of Kyrstexxa, or is something rotten under the company’s shiny surface?

Something is indeed rotten – Savient’s management. Immediately after receiving FDA approval for Kyrstexxa, the management team attempted to auction the company off to the highest bidder, which caused investors to lose confidence in the company and dump shares. At the time, Savient believed that it didn’t have the capital to develop a sales and marketing team, and would incur losses which would be better spent on research and development for new products. Therefore, the company’s management believed that a big pharmaceutical company – such as Novartis AG (NVS: Charts, News, Offers), Pfizer (PFE: Charts, News, Offers) or Merck (MRK: Charts, News, Offers) would be better equipped to market Kyrstexxa, and they expected these big buyers to pay a high premium on the stock price to acquire its drug.

However, the big fish didn’t bite, and the management didn’t profit – they only sunk their own stock – crashing from above $23 to $9 after its last attempt to auction itself off failed. Shares of Savient had been trading near $15 prior to FDA approval, which may lead value investors to point out that its current share price at $11 is irrational. However, at $11 the stock still trades at a massive 15.6 times book value, compared to an industry price to book ratio of 3.2, meaning that the company simply doesn’t have the cash or earnings per share to back up its share price, with considerable downside risk. However, Savient still has a drug which is attractive to either large pharmaceuticals or a generic drug maker such as Teva Pharmaceuticals (TEVA: Charts, News, Offers), and the purchase of the company seems inevitable. However, with a series of failed auctions, buyers may be waiting for Savient’s stock price to collapse before swooping in to pick up the company at a steep discount.

The company has since launched its Kyrstexxa by itself, spending capital training a sales force in January and hiring former ImClone Systems CEO John Johnson to oversee operations. Analysts believe that Kyrstexxa could bring in sales of $600 million in the United States along for the first quarter of 2011, which is based on approximately 10,000 patients being administered the drug. Beyond the current quarter, analysts forecast that the number of patients using Kyrstexxa could increase to 45,000-56,000, which could bring in approximately $3 billion in the future. In the United States alone, approximately 100,000 of 2 million gout patients suffer from severe refractory gout, an estimate which Savient claims is closer to 170,000, which would be in critical need of Kyrstexxa. Investors, analysts and potential buyers are watching Savient’s earnings report on May 5 in expectations of revenue between $2 to $3 million which would signal that demand for Kyrstexxa is healthy and growing. Anything under that may cause shares to crash further, as the company becomes even less attractive to large pharmaceutical companies.

Cancer News and Treatment

Researchers find new lung cancer treatment

RESEARCHERS looking for better ways to treat tumours in children say they may have stumbled instead on something even better – a new therapy for lung cancer, Australia’s single biggest cancer killer.

Lung cancer is the fifth-most commonly diagnosed cancer in this country, accounting for 9703 diagnoses in 2007 – fewer than half the 19,403 new prostate cancer cases recorded the same year.

It also lags well behind bowel cancer (14,234 cases), breast cancer (12,670) and melanoma (10,342).

But lung cancer remains far and away the single most deadly cancer, claiming 7626 lives in 2007 – nearly double the number of the next-biggest, bowel cancer (4047).

Part of the reason lung cancer remains so deadly is that it is often detected relatively late, and is often difficult if not impossible to remove surgically.

But scientists at the Children’s Cancer Institute Australia, in Sydney, have found a new approach that promises to tackle another reason why the prognosis for most patients with lung cancer can be so poor: the tendency for their tumours to resist chemotherapy drugs.

Maria Kavallaris, the head of the CCIA’s tumour biology and targeting program, and a former president of the Australian Society for Medical Research, said her team used a “gene-silencing” approach to knock out the gene in the cancer cells that made them resistant to the effects of chemotherapy.

The findings, presented at the Australasian Gene Therapy Society meeting in Melbourne yesterday, have so far been tested successfully in mice, and Professor Kavallaris said she hoped human trials would begin next year.

“When we switch off this gene, and treat the cancer cells with the chemotherapy that they weren’t responding to before, then they become responsive,” Professor Kavallaris said.

“It’s still early days, but it’s showing great promise. It’s very encouraging.”

The researchers are still trying to work out how best to deliver the drug to cancer cells in live patients – such as injection, or steady infusion through a drip.

It is hoped the therapy, if successful in later trials, could also prove useful for solid cancers in children, such as neuroblastoma – which is one of the most aggressive childhood cancers.

A new treatment for childhood cancers such as neuroblastoma was what the CCIA team were looking for when they realised their therapy could be of benefit to adult patients as well.

First Wednesday events to support cancer treatment and survivors

It’s time to Paint the Town Purple for First Wednesday this month.

Go Downtown and Relay for Life are working together for the event, which is in its second year. Relay teams will be gathered throughout downtown Salem to raise money for the June 17-18 event, and cancer survivors are encouraged to check in at the survivor’s table at Liberty and Court streets NE.

The highlight of the evening will be the Luminaria Concert, which begins at 7:30 p.m. in the Trinity Ballroom of the Reed Opera House, 189 Liberty St. NE.

The concert will feature some of Oregon’s biggest names in blues and soul, including Norman Sylvester, Garry Meziere, Dave Fleschner, Larry London and Terry Robb. They will play together, but you can hear them individually during the “Battle for the Best — Tunes for Tips” solo competition; vote with your money for the best performance.

During the concert, sponsorships for 11 lap quilts will be auctioned off; there is a suggested $25 starting bid. In turn, the lap quilts will go to people in cancer treatment.

Inside and outside the ballroom will be the paper lanterns called “luminarias,” which will be lighted to honor a survivor or memorialize someone who has died.

The concert is free, but there is a suggested $3 donation. All proceeds will go to Relay for Life.

Elsewhere, Travel Salem (181 High St. NE) will host a wine tasting and reception. At Dave Wilson Designer Goldsmith, 216 Commercial St. NE, Susan Trueblood Stuart will show “Painting My Way Through Cancer,” 21 paintings she made during her struggle with jaw cancer.

Per usual, there are gallery shows, restaurant specials and shop sales.

Nucletron Showcases Five Innovations in Cancer Treatment at ESTRO

Nucletron, a leading provider of state-of-the-art radiotherapy solutions for cancer treatment will feature five new innovations at the ESTRO Anniversary Congress, May 8-11 in London, all designed to meet the growing interest and need to more effectively treat a wide variety of cancers. In addition, as one of the first industry partners with the organization, Nucletron will be celebrating its long collaboration with ESTRO on its 30th anniversary.

“2011 is the Year of Radiotherapy in the UK, and there is no better location than London for ESTRO to hold this year’s meeting and commemorate its 30th anniversary. Nucletron is proud of our long term partnership with ESTRO, and we’re looking forward to working with the organization and its members to further advance the important role of radiotherapy, in particular brachytherapy, in the multimodality treatment of cancer,” said Jos Lamers, CEO of Nucletron. “Our commitment to product innovation, professional education, and raising awareness of the benefits of brachytherapy – all aimed at ensuring patient access to quality cancer care – will highlight Nucletron’s presence at this year’s meeting,” he added.

Nucletron will feature five innovative products and solutions at this year’s meeting, all of which were developed with the needs of the modern radiotherapy department for speed, efficiency, accuracy and quality in mind. Awareness of brachytherapy will also receive special attention, with the presentation of a range of awareness and educational materials.

The Vaginal CT/MR Multi Channel Applicator (VCMC) is the first Precise Dose Delivery Solution (PDDS(TM)) for treating gynecologic cancers. The VCMC features a unique design of multiple channels which are curved in the tip of the applicator, and which can be loaded selectively. This provides accurate precision and dose direction, bringing dosimetry measurably closer to the vaginal wall. The VCMC is easy to assemble, clean & sterilize, thus providing economical treatment and optimized day-to-day utilization. This new addition to Nucletron’s range of innovative applicators allows healthcare providers to tackle more complex or advanced endometrial and other gynecological cancers. The recent PORTEC (Postoperative Radiation Therapy for Endometrial Carcinoma) 2 study highlighted the benefits of vaginal brachytherapy versus external beam radiotherapy, in particular significantly lower toxicity and superior QOL outcomes. Delivering the dose where it is most needed, a key aspect of brachytherapy in sparing healthy tissue and reducing treatment toxicity, makes this unique CT/MR-compatible applicator a logical solution in response to the demands of modern gynecologic radiotherapy.

Nucletron’s Prostate Solutions represent a seamless, all-in-one solution that addresses clinical needs, whether these call for low dose rate (LDR or “seeds”), High Dose Rate (HDR) or both. This all-in-one solution is the only one to cover both HDR & LDR in one software configuration. It combines dynamic treatment planning and delivery with advanced robotic accuracy, thereby improving clinical outcomes in patients undergoing prostate brachytherapy. Built around the latest state-of-the-art Oncentra(R) software, each solution integrates ultrasound technology allowing optimal control over the treatment process. Nucletron’s advanced Robotic Seed Delivery technology guarantees reliable, reproducible and precise treatment. The unique combination of dynamic treatment planning and delivery with advanced robotic accuracy helps health care professionals improve clinical outcomes in patients undergoing prostate brachytherapy.

Nucletron will also be showcasing the latest version of its brachytherapy treatment planning solution Oncentra (R) Brachy. Developed with the needs of the busy radiotherapy department in mind and with a focus on shortening workflows, it combines up to 50% reduction in planning times with exemplary treatment planning accuracy. Key components of Oncentra Brachy 4.0 are library plans and GYN applicator models, the first in a series of applicator models. The ability to automatically reconstruct exact applicator geometry from a 3D library eliminates the uncertainty of individual interpretation and assures placement precision. Furthermore, the new libraries and automatic reconstruction can dramatically reduce the time needed for planning, without compromising on quality. This latest edition of Nucletron’s advanced brachytherapy software also addresses the call for reproducibility, leveraging applicator models and library plans to ensure consistency, be it between fractions or between users.

Nucletron’s commitment to external beam treatment planning will also be very much on show, with two leading edge solutions.

The first, the latest release of Oncentra External Beam, intelligently automates routine planning tasks and increases patient throughput. Speed is very much of the essence with the premier of Oncentra’s GPU technology which dramatically speeds up dose calculation, reducing complex calculation times from hours to minutes for enhanced dose algorithms. Users of Oncentra External Beam 4.0 can now routinely have collapsed cone accuracy, in pencil beam times, and creating a 3D plan can take as little as 15 seconds. Oncentra connects to all treatment delivery systems. Its modular planning environment allows it to be used with a department’s linear accelerator of choice and still benefit from the latest in planning tools and technology offered in this new version.

The second, Velocity, brings the best of modern radiotherapy – multiple modality, dose summation and adaptive planning – directly to the radiotherapy department. This innovative solution allows users to turn the sheer volume of data and complexity of today’s radiotherapy directly to their advantage. A unique range of integration tools provides the ability to combine images from multiple modalities, integrate dose summation regardless of source, and apply adaptive contouring across multiple datasets with both accuracy and speed. Velocity eliminates repetitive and time-consuming segmentation tasks by leveraging proprietary anatomy atlases, significantly decreasing treatment planning time and complexity. This new solution provides the user with the full “patient” picture and the advantage of an accelerated workflow.

To learn more about these new innovations in precision cancer treatment, visit Nucletron during the ESTRO Anniversary Conference at booth 110.

HIV drug could lead to new cervical cancer treatment

The HIV protease inhibitor lopinavir (a component of Kaletra) triggers cells infected with human papillomavirus to produce an antiviral protein, inducing death of the cancerous cells, researchers at the University of Manchester report in the journal Antiviral Therapy.

“We have now found that lopinavir selectively kills HPV-infected, non-cancerous cells, while leaving healthy cells relatively unaffected,” said Dr Ian Hampson, from Manchester’s School of Cancer and Enabling Sciences.

The finding could lead to a new form of treatment for cervical cancer, which is caused by certain high-risk types of human papillomavirus.

At present treatment options for precancerous lesions caused by human papillomavirus, and for cervical cancer, are limited to freezing with liquid nitrogen in early stages, to electrocauterisation, or to surgery and chemotherapy in cases of cervical cancer.

However, in low and middle-income settings surgical treatments for precancerous lesions and for cervical cancer are often more difficult to deliver due to limited screening programmes, a lack of surgically trained staff and lack of medicines. Due in part to these obstacles, cervical cancer is the most common malignancy in women in sub-Saharan Africa.

Treatments which can be delivered easily by nurses and by affected women, starting on the day when a precancerous lesion is identified, could be particularly important in reducing progression to cervical cancer and deaths from cervical cancer in the developing world.

Although HPV vaccination is being introduced in some countries it cannot protect women who have already developed precancerous changes or who have been infected by high-risk HPV types that are not included in the two vaccines now available.

More generally, a drug which is effective against HPV could revolutionise the prevention of anal and oral cancers caused by HPV.

The University of Manchester researchers tested the effect of lopinavir on HPV-infected cells derived from cervical cancer and from human foreskin.

They found that lopinavir increased the production of ribonuclease L in cells infected with cancer-causing HPV types. HPV appears to reduce the expression of ribonuclease L, but the process which HPV reduces Ribonuclease L expression is inhibited by lopinavir.

The authors also speculate that the same process could lower host antiviral defences and so permit infection with other viruses, indicating a possible explanation for the association between HPV infection and subsequent risk of HIV infection in men and in women.

Co-author on the paper, Dr Lynne Hampson, said: “These results are very exciting since they show that the drug not only preferentially kills HPV-infected non-cancerous cells by re-activating known antiviral defence systems, it is also much less toxic to normal non-HPV infected cells.

“Lopinavir is obviously safe for people to take as tablets or liquid but our latest findings provide very strong evidence to support a clinical trial using topical application of this drug to treat HPV infections of the cervix.”

Standard dose Kaletra treatment in women with HIV is unlikely to show an association with a reduced risk of cervical cancer due to the dose needed to kill HPV-infected cells.

Dr Hampson said: “Our results suggest that for this drug to work against HPV it would be necessary to treat virus-infected cells of the cervix with roughly 10-15 times the concentration that is normally found in HIV-infected patients taking lopinavir as tablets. This implies that, for this treatment to work, it would need to be locally applied as a cream or pessary.”

Obesity Today: News and Treatment

Could obesity treatment lower death risk?

Obesity treatment could be needed by people suffering from coronary artery disease who tend to put weight on around their stomach.

According to research from the Mayo Clinic, published in the Journal of the American College of Cardiology, people with belly fat and coronary artery disease are twice as likely to die as those who tend to put on weight elsewhere.

Francisco Lopez-Jimenez, lead investigator of the project, commented: “Visceral fat has been found to be more metabolically active. It produces more changes in cholesterol, blood pressure and blood sugar.

“However, people who have fat mostly in other locations in the body, specifically, the legs and buttocks, don’t show this increased risk.”

The research team looked at data from nearly 16,000 people involved in five studies around the world and confirmed that ‘central obesity’ increased the risk of death.

According to the researchers, physicians should consider counselling coronary artery disease patients with normal body mass indexes to lose weight if they have a large waist circumference or a high waist-to-hip ratio.

Discrimination hurts: Lack of fair treatment leads to obesity issues

People, especially men, who feel any kind of discrimination, are likely to see their waistlines expand, according to research from Purdue University.

“This study found that males who persistently experienced high levels of discrimination during a nine-year period were more likely to see their waist circumference increase by an inch compared to those who did not report discrimination,” said Haslyn E.R. Hunte, an assistant professor of health and kinesiology. “Females who reported similar experiences also saw their waistlines grow by more than half an inch. This shows how discrimination hurts people physically, and it’s a reminder how people’s unfair treatment of others can be very powerful.

“People who feel unfairly treated should be aware of this connection between the stress related to their perception and consider coping strategies like exercise or other healthy behaviours as a coping mechanism for such stress. More importantly, as a society we must become more aware of how we treat people and that treating others unfairly matters beyond hurt feelings.”

These findings are published online in the American Journal of Epidemiology. The study, based on a predominantly white sample of more than 1,400 people, compared health and ageing data from the 1995 and 2004 National Survey of Midlife Development in the United States. Hunte found that people who reported recurring discrimination tended to have a higher increase in waist circumference over time. Men reported an average of 2.39 centimetres increase in waist circumference compared to those who reported low levels of discrimination, and women reported an average increase of 1.88 centimetres over others during the nine-year period.

“While this study shows there is a difference between men and women, it doesn’t provide specific reasons for that difference,” Hunte said. “More research will need to be done to understand how and why men and women cope differently with this stress or if there are differences in how their bodies react.”

Hunte focused on waist circumference – instead of the body mass index formula, which measures obesity based on height and weight –because abdominal fat is a better indicator of poor cardiovascular-related health outcomes than body mass index.

“Being fat is not healthy, but there are greater problems with individuals who are more pear shaped, meaning that fat builds up in their waist region, rather than someone whose fat is deposited throughout the body,” Hunte said. “There is some indication that stressors, such as interpersonal discrimination, can concentrate fat around the midsection. We’re not sure why, and more work needs to be done to understand this connection between behaviour and physiology. How does what’s above the skin affect what is taking place under the skin?”

People who reported ongoing perceptions of discrimination said they were treated with less courtesy than others, received poorer customer service or people acted as if they were afraid of them. The source of discrimination is not known, but Hunte did exempt individuals who reported that they felt discrimination due to their weight.

Hunte is planning to investigate this further by studying biomarkers, such as cortisol, which is a stress-induced hormone, in relationship to effects of discrimination.

Hunte was supported by the Department of Health and Kinesiology and the Robert Wood Johnson Foundation Health and Society Scholars program. The national survey was funded by National Institute of Aging and the John D. Catherine T. MacArthur Foundation Research Network on Successful Midlife Development.

Vivus trims 1st-quarter loss on lower spending

Drug developer Vivus Inc. said Monday that it posted a smaller loss for the first quarter as it spend less on research and development as its drugs neared approval.

Vivus also said it is looking to resubmit its application for approval of obesity drug Qnexa to the Food and Drug Administration in the fourth quarter. The approval is being sought to market Qnexa as a weight-loss treatment for men and women past child-bearing age.

The FDA declined to approve Qnexa in October, and it has asked Vivus to look into the risk of birth defects in women who use topiramate as a migraine treatment. Topiramate is an ingredient in Qnexa. The company met with the FDA earlier this month to discuss performing a retrospective study using existing electronic healthcare databases to assess birth defects in the children of women who were exposed to topiramate during pregnancy. Vivus said it has reached agreement with the FDA on the study’s design, goals and eligibility criteria.

Vivus reported a loss of $9.9 million, or 12 cents a share, for the three months ended March 31. That compares with a loss of $18.8 million, or 23 cents a share, in the prior-year quarter. The results beat analysts’ consensus forecast for a loss of 15 cents a share, according to FactSet.

The company spent $4.5 million on research and development during the quarter, down from $10.2 million in the prior-year period. The sharp decline in spending was due to Vivus’ avanafil project and potential obesity treatment Qnexa each progressing from the clinical trial stage to the approval stage.

Shares of Vivus added 45 cents, or 5.8 percent, to $8.23 in aftermarket trading. The shares rose 3 cents to $7.80 during the regular session.

Needed health care put off because of high cost, UW study shows

The high cost of health care is hurting everyone, with parents forgoing taking their sick kids to the doctor even if they have health insurance and make enough money to cover the cost, according to a new study from researchers at UW-Madison.

A research team from the UW-Madison School of Medicine and Public Health said the cost of health care relative to a family’s income, plus having a child with a limitation such as asthma, autism or obesity, can make families put off needed medical care.

The findings were presented on Sunday at the Pediatric Academic Societies annual meeting in Denver, and were released on Tuesday by the UW-Madison news service.

The research team was headed by doctoral student and graduate research assistant Lauren Wisk.

“Families aren’t choosing to spend their money on going to the doctor when someone is sick because of how much it cost them to see the doctor the last time,” Wisk said in the release. “They are sacrificing their health because it costs too much to be healthy.”

The team looked at data from six years’ worth of surveys on 6,273 families with at least one child.

Excessive financial burden was defined as a family using at least 10 percent of its income on insurance premiums and out-of-pocket health care expenses, and delayed or forgone care was defined as putting off or going without treatment or prescription medication because of the cost.

The study showed families experiencing excessive financial burdens, having a child with an ongoing limitation and a parent with intermittent insurance all increased the chances health care would be delayed or not used.

“Every U.S. family has a finite amount of resources available, and every day decisions have to be made how to allocate those resources,” Wisk said. “This study shows the unfortunate reality of the situation.”

More research is planned to see how delaying or forgoing care affects health down the road.

“We expect that if people aren’t getting the care they need, they will be sicker as a result,” Wisk said.

“When you put this all together, the cost of health care in the U.S. could actually be causing Americans to be sicker.”

Editor’s Commentary – Association of obesity with prostate cancer: A case-control study within the population-based PSA testing phase of the ProtecT study

Obesity is not associated with prostate cancer (CaP), according to a report by Dr. Polyxeni Dimitropoulou and collaborators that appears in the online version of the British Journal of Cancer.

The authors note that obesity is associated with a number of chronic diseases such as coronary artery disease, hypertension and diabetes as well as CaP mortality, but it is not clearly associated with CaP incidence. This is a case-control study nested within the PSA-testing phase of the Prostate testing for cancer and Treatment (ProtecT) study. It evaluates associations of obesity with screening-detected CaP. Obesity was measured by body mass index (BMI), waist circumference and waist-to-hip ratio (WHR).

Patients included in the analysis were age 50-69 years who had PSA testing and a diagnosis of CaP. They were matched for clinicopathologic characteristics with controls. Assessed metrics were both objective and patient-reported. Data was complete for BMI, age and family history for 3,931 controls and 919 cases.

More cases (8.1%) than controls (5.2%) had a family history of CaP. Regarding obesity, in the highest tertiles there were 18.4% cases and 21.5% controls with a BMI ≥30kg m-2. There were 30.5% of cases with >99cm waist circumference compared with 32.1% for controls. WHR was >0.95 in 31.8% of cases and 33.9% of controls. After exclusions for missing data, the number of cases (1,089) and controls (5,020) used in the analysis was similar to the eligible participants not included in the analysis in terms of family history of CaP. However, in terms of age, those included were on average one year older than those not included. Considering BMI, waist measurement and WHR, there was no relationship between any of these three obesity measures and total prostate cancer. Only BMI had a minimally significant relationship to pathological stage or grade.

Dimitropoulou P, Martin RM, Turner EL, Lane JA, Gilbert R, Davis M, Donovan JL, Hamdy FC, Neal DE