Cerulean Announced CRLX101 Data Publication in PNAS

Biotech company Cerulean Pharma Inc. reported back in March 2013 that its potential treatment of late-stage, non-small cell lung cancer (NSCLC), the most common form of lung cancer, failed in a Phase 2b trials. Though the study of its experimental, anti-tumor treatment, CRLX101, showed signs of activity including tumor reductions and favorable safety profiles, the results did not meet its primary efficacy endpoint, overall survival benefit.

Press release, below, addresses the publication of study results of CRLX101; and suggests preclinical behavior of CRLX101 is translatable to humans.

SOURCE: SOURCE Cerulean Pharma Inc.

Cerulean Announces Publication of Data from Company's Lead Candidate, CRLX101, in Proceedings of the National Academy of Sciences (PNAS)

Study results suggest preclinical behavior of CRLX101 is translatable to humans

CAMBRIDGE, Mass., Sept. 9, 2013 /PRNewswire/ -- Cerulean Pharma Inc., a leader in dynamically tumor-targeted nanopharmaceuticals, today announced the publication of translational data on the company's lead candidate, CRLX101, currently in Phase 2 trials. The study results, which are published in PNAS, indicate that animal pharmacokinetic and pharmacodynamic data are translatable to humans.

Results from Phase 1 and 2 clinical trials that have been correlated to preclinical data and discussed in the paper include:

1.    A consistent manufacturing process across numerous lots of CRLX101 was observed, as evaluated by particle size, polymer molecular weight and drug loading, resulting in no significant differences in pharmacokinetics or urinary excretion in patients treated with more than one clinical lot.

2.    Low patient-to-patient variations in plasma concentrations of CRLX101, unlike what has been observed with liposomes.

3.    Similar time- and concentration-dependent behavior of camptothecin concentration between patients and animals.

4.    Consistent pharmacokinetics upon repeat dosing in patients.

5.    Predictable release kinetics of camptothecin that is largely enzyme independent.

6.    Slow release over time of the drug once in tumors, leading to a durable inhibition of topoisomerase 1.

7.    Deep permeation of intact nanoparticles in mouse and human tumors, which will enable the killing of tumor cells far from the vasculature.

"CRLX101 is designed to preferentially target tumors through leaky neovasculature, achieve uptake into cancer cells, and release its payload over time from within the cancer cells," said Mark E. Davis, professor of chemical engineering at the California Institute of Technology, scientific advisor to Cerulean, and inventor of CRLX101.

Scott Eliasof, vice president of research at Cerulean, commented: "It's difficult to obtain data on how nanoparticles work in humans. As a result, this evaluation comparing clinical trial and preclinical studies is valuable because it demonstrates that in the case of CRLX101, animal studies are a strong predictor of results in human trials."

The paper, "Correlating preclinical animal studies and human clinical trials of a multifunctional, polymeric nanoparticle," was co-authored by Mark E. Davis of the California Institute of Technology, Scott Eliasof of Cerulean Pharma, and others at Cerulean, Calando Pharmaceuticals, City of Hope Comprehensive Cancer Center and the California Institute of Technology. It is available at http://www.pnas.org/content/early/2013/08/21/1309566110.full.pdf+html.

About CRLX101 
CRLX101 is an investigational anti-cancer agent that inhibits topoisomerase 1 (Topo 1) and hypoxia-inducible factor-1a (HIF-1a). Topo 1 is an essential cell replication enzyme and a commercially validated anti-cancer target. HIF-1a is a master regulator of cancer cell survival mechanisms such as cancer stem cell formation and  is upregulated under hypoxic conditions created by traditional cancer therapies, for example anti-angiogenic agents and radiation. To date, HIF-1a has been undrugable. CRLX101 is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumors and release its payload, camptothecin, over an extended period of time, prolonging drug exposure at the site of action. CRLX101 has been dosed in more than 200 patients, many for more than six months. Anti-tumor activity (multiple RECIST responses and prolonged stable disease) has been observed in three different tumor types in highly refractory treatment settings, as monotherapy and in combination with Avastin^®. CRLX101 is currently in Phase 2 clinical development. More information on CRLX101 clinical studies can be found at www.clinicaltrials.gov.

About Cerulean Pharma Inc.
Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumor-targeted nanopharmaceuticals. Cerulean is applying its proprietary nanopharmaceutical platform to advance a new class of therapeutic agents to address significant unmet medical needs. With an initial focus in oncology, the Company's technology platform can be applied to a wide range of drug molecules, ranging from small molecules to peptides and RNAs. Cerulean is privately held and funded by leading investors, including Polaris Venture Partners, Venrock, Lilly Ventures, Lux Capital, and CVF, LLC. Cerulean is located in Cambridge, Massachusetts. For more information, please visit the Company's website at http://www.ceruleanrx.com.

Media Contact:
Laura Kempke 
Schwartz MSL
cerulean@schwartzmsl.com 
+1 781-684-0770

SOURCE Cerulean Pharma Inc.

Web Site: http://www.ceruleanrx.com

Safe Kids Worldwide, JNJ Report: 1.35M times per year, young athletes seen in ER for sports-related injuries

According to new report, 1.35 million times a year, a young athlete is seen in Emergency Rooms for sports-related injuries. Female athletes are eight times more likely to have knee injuries than male athletes. Of the 14 most popular sports studied, concussions account for 163,000 of those ER visits, or 12 percent.

Full press release follows.

SOURCE: SOURCE Safe Kids Worldwide, www.safekids.org

WASHINGTON, Aug. 6, 2013 /PRNewswire/ -- Every 25 seconds, or 1.35 million times a year, a young athlete suffers a sports injury severe enough to go to the emergency room, according to a new research report released today by Safe Kids Worldwide.

(Photo:  http://photos.prnewswire.com/prnh/20130806/MM58298)

The report, "Game Changers," made possible with support from Johnson & Johnson, takes an in-depth look at data from the U.S. Consumer Product Safety Commission's National Electronic Injury Surveillance System (NEISS) to explore what type of injuries are sidelining young athletes.

According to the report that studied the 14 most popular sports, concussions account for 163,000 of those ER visits, or 12 percent. That's a concussion-related ER visit every three minutes. Surprisingly, it is not just high school athletes suffering concussions; athletes ages 12 to 15 make up almost half (47%) of the sports-related concussions seen in the ER, a statistic made even more disturbing by the knowledge that younger children with concussions take a longer time to recover than older children.

The report also revealed that knee injuries account for one in ten sports-related injuries. Knee injuries, specifically tears to the anterior cruciate ligament (ACL), are disproportionately affecting young female athletes, who are up to eight times more likely to have an ACL injury than male athletes.

"We uncovered some surprising and disturbing data about how often our kids are being injured playing sports," said Kate Carr, president and CEO of Safe Kids Worldwide. "But we also found some inspiring stories from people and programs that are making a marked difference."

The study details both the types of injuries and the rates of injuries for the most popular sports. Not surprising, in 2011, the sport with the most injuries is football, which also has the highest concussion rate. Wrestling and cheerleading have the second and third highest concussion rate. The sport with the highest percent of concussion injuries is ice hockey. 

The report also includes profiles of actions some communities, sports leagues, and individual athletes who are taking a proactive stance in order to turn these statistics around.

Game-Changing Strategies 
The report outlines and endorses four overarching strategies that communities, coaches, parents and athletes are implementing to make a difference.

•   Get educated, then pass it forward. A common theme among parents and young athletes who are struggling with recovering from an injury is that they wish they knew sooner what they know now. Attend a Safe Kids sports clinic or go to www.safekids.org to find out how to keep kids safe, then tell your friends.

•   Teach athletes injury prevention skills. Instill smart hydration habits, warm-up exercises and stretches to prevent common injuries. Understand stress placed on muscles particular to the sport (pitching arm, knees, etc.) and target exercises to those areas. (Check out this video to strengthen knees and prevent ACL injuries.) Encourage athletes to get plenty of rest.

•   Encourage athletes to speak up about injuries. Too often, athletes feel like they are letting down their teammates, coaches or parents if they ask to sit out. The truth is it takes more courage to speak up about an injury that can have serious and long-term effects.

•   Support coaches in injury prevention decisions. A Safe Kids Worldwide 2012 survey found half of coaches admit to being pressured by a parent or athlete to keep an injured athlete in the game. Coaches need to be educated and confident in making decisions that protect the long-term interests of young athletes.

"Most states have laws to protect young athletes," said Carr, "but the front line of protection for our kids is parents and coaches. Working together, we can keep our kids active, strong and safe so they can enjoy the sports they love for a lifetime."

Keeping kids safe is a team effort. There is nothing more important than growing healthy, happy kids. Throughout our 25 year partnership, Safe Kids and Johnson & Johnson have remained committed to reducing preventable injuries in children.

Safe Kids Worldwide is a global network of organizations dedicated to providing parents and caregivers with practical and proven resources to protect kids from unintentional injuries, the number one cause of death to children in the United States. Throughout the world, almost one million children die of an injury each year, and every one of these tragedies is preventable. Safe Kids works with an extensive network of more than 600 coalitions in the U.S. and in 23 countries to reduce traffic injuries, drownings, falls, burns, poisonings and more. Since 1988, Safe Kids has helped reduce the U.S. childhood death rate from unintentional injury by 55 percent. Working together, we can do much more for kids everywhere. Join our effort at safekids.org.

SOURCE Safe Kids Worldwide

Hansen Medical, New Clinical Study Enrollment Commencement

Hansen Medical announces enrollment of first patients into new clinical study evaluating the use of the Artisan(R) family of Control Catheters with the Sensei(R) X Robotic System for the treatment of atrial fibrillation. If successful, Hansen Medical intends to use the new clinical study data to support a submission to the FDA to obtain approval for a broader label claim for use of the Artisan family of Control Catheters with the Sensei X Robotic Catheter System in atrial fibrillation procedures.

Full press release below.

SOURCE: Hansen Medical, Inc.

MOUNTAIN VIEW, CA -- (Marketwired) -- 08/05/13 -- Hansen Medical, Inc. (HNSN), a global leader in intravascular robotics, today announced that the first patients have been successfully enrolled in the new study design of its ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of Hansen Medical's Artisan® family of Control Catheters with its Sensei® X Robotic Catheter System for treatment of Atrial Fibrillation (AF), the most common cardiac arrhythmia. In May, the Company announced that it had received conditional approval of the new study design from the U.S. Food and Drug Administration (FDA).

Under the revised protocol, the study will be a single arm, target performance goal study enrolling as few as 125 subjects at up to 14 investigational sites. The principal investigator of the full trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive director for Texas Cardiac Arrhythmia Institute. The co-principal investigator is Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Research Foundation (TCARF) and his team. Dr. Gallinghouse was the first physician to enroll a patient into the study under the revised protocol following IRB approval.

"I am pleased to be the first physician to enroll a patient into this new study," said Dr. Gallinghouse. "The new study design recently agreed upon with the FDA will greatly facilitate enrollment in the trial, and allow us to evaluate clinical endpoints in an expedited fashion. I look forward to continuing to enroll patients into and completing this critical evaluation of ablation of atrial fibrillation using robotic navigation."

"The enrollment of patients into this study is an important milestone for Hansen Medical,” said Hansen Medical President and CEO, Bruce Barclay. "If successful, we intend to use the data derived from this study to support a submission to the FDA to obtain approval for a broader label claim for use of our Artisan family of Control Catheters with our Sensei X Robotic Catheter System in atrial fibrillation procedures. The achievement of a broader label claim has the potential to drive further growth of our U.S. EP business."

Atrial Fibrillation is the most common cardiac arrhythmia, and it affects an estimated 3.3 million Americans and 4.5 million Europeans. This number is expected to increase due to an aging population and a rising number of people with chronic heart disease. AF is associated with increased long-term risk for severe and disabling stroke.

About Sensei ® X Robotic Catheter System
Through continued advancement of medical robotics, Hansen Medical has developed a next generation minimally-invasive, robotic catheter system, the Sensei X Robotic Catheter System, which combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in over 10,000 patients, and is powered by an accurate, robotically controlled arm that allows for catheter navigation, stability and positioning within the patient's heart atria, allowing for the following system advantages:

            Catheter Stability with Force-Sensing

            Instinctive 3D Control

            Potential for Reduced Fluoro Time for Physician

About Hansen Medical, Inc. 
Hansen Medical, Inc., based in Mountain View, California, is a global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company's Magellan" Robotic System, 9Fr Magellan" Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company's Sensei® X Robotic Catheter System and Artisan® and Artisan Extend® Control Catheters are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S., the Company's Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheters are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the U.S., the Sensei X Robotic Catheter System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X Robotic Catheter System and Artisan and Artisan Extend Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "potential," "believes," "goal," "estimate," "anticipates," and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements regarding the timing and potential results of the ARTISAN-AF Trial and statements about the anticipated growth in Hansen Medical intravascular robotics technology for EP and vascular applications. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating to engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; the commercial viability of our products in the electrophysiology and vascular markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 filed with the SEC (SCUR) on May 10, 2013 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. The Company undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investor Contacts:

Peter J. Mariani

Chief Financial Officer

Hansen Medical, Inc.

650.404.5800

FTI Consulting, Inc.

Brian Ritchie

212.850.5683

Email Contact

John Capodanno

212.850.5705

Email Contact

Source: Hansen Medical, Inc.

New Data for Abbott's Investigational High Sensitive Troponin Test Shows It May Help Doctors Predict Heart Attack Risk

New data for Abbott's Investigational High Sensitive Troponin Test shows it may help doctors predict heart attack risk. The study, conducted by researchers at Brigham and Women's Hospital, demonstrated that Abbott's hsTnI test (currently for research-use only in the US) may help doctors predict which patients presenting with symptoms of a heart attack, such as severe chest pain, are at a higher risk for having a heart attack 30 days later.

Full press release follows.

SOURCE: Abbott

HOUSTON, July 30, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) announced today promising results from a study evaluating its High Sensitive Troponin-I (hsTnI) assay presented at this year's American Association for Clinical Chemistry (AACC) annual meeting in Houston, Texas. The study, conducted by researchers at Brigham and Women's Hospital, demonstrated that Abbott's hsTnI test (currently for research-use only in the United States) may help doctors predict which patients presenting with symptoms of a heart attack, such as severe chest pain, are at a higher risk for having a heart attack 30 days later.

A concern for patients who present with severe chest pain is that they are more likely to experience another cardiovascular event within a few weeks or months. Researchers at Brigham and Women's Hospital evaluated the performance of a hsTnI assay (Abbott, ARCHITECT) with the performance of a fourth generation troponin T assay (Roche, TnT) among 4,695 patients presenting with severe chest pain and found that the hsTnI assay identified more patients at higher risk of recurrent heart attack, even at very low troponin concentrations.

"The ability to identify patients at higher risk for another heart attack or cardiovascular death is an essential step in their prevention," said Dr. Petr Jarolim, M.D., Ph.D., one of the key authors of the study and Medical Director, Clinical Chemistry and Laboratory Control, Brigham and Women's Hospital. "This study demonstrates that the new high sensitivity cardiac troponin assays are efficient tools for classifying patients, allowing doctors to provide more aggressive treatment of those at higher risk."

Cardiac troponin, a protein found in the heart muscle, is considered the preferred biomarker used to identify suspected heart attacks, because it can detect injury to the heart.¹ Abbott's ARCHITECT STAT hsTnI assay can measure very low levels of the protein, which allows doctors to evaluate whether or not patients are having a heart attack within two to four hours after presentation.² This faster evaluation could allow doctors to reduce the time to diagnosis and treatment by several hours when compared to standard troponin tests.

"This study adds to the clinical evidence confirming the advantages of Abbott's high sensitive troponin test to provide more insight to clinicians about which patients are at greater risk for a future heart attack as compared to contemporary tests," said John Frels, PhD, divisional vice president, Diagnostics Research, Abbott. "This is important information for patient care because it may help doctors focus on the patients at greater risk for appropriate management."

The abstract for this study was selected as the first annual recipient of the Biomarkers of Acute Cardiac Disease Division Outstanding Abstract Award. The committee awarded a grant for outstanding abstract to one of the key authors of the study, Dr. Petr Jarolim (Brigham and Women's Hospital).

The ARCHITECT STAT hsTnI assay is commercially available in Europe and runs on Abbott's fully-automated ARCHITECT family of analyzers.

About Abbott Diagnostics

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 22,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness, and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.

About Abbott

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.

¹ Thygesen K, Alpert JS, Jaffe AS et al. Third universal definition of myocardial infarction. European Heart Journal. 2012; 33:2551-2567.

² Abbott ARCHITECT STAT High Sensitive Troponin-I Product Insert (PI), January 2013.

SOURCE Abbott

CONTACT: Media, Darcy Ross, (847) 937-3655 (office), (224) 475-7673 (mobile), or Jessica Masuga, (847) 935-0650 (office), (847) 970-1391 (mobile), or Financial, Tina Ventura, (847) 935-9390

Web Site: http://www.abbott.com