April 24, 2012

Interferon-Free Regimens at EASL 2012


Provided by NATAP (All links open into new windows)

from Jules: There are about 8 interferon-free regimens below and/or presented at EASL, again bear in mind this is a work in process, this is the first step in designing the best interferon-free terapies, but the SVR rates are very good here, although admittedly in small studies this shows and proves what we are capable of seeing here, with better & more potent regimens coming in the future. All the companies & researchers are working towards 2-4 drug all oral regimens for naives with SVR rates approaching & achieving for some 100%. For null-responders we will likely need improved regimens, at this meeting Abbott reported 94% SVR rates with 12 weeks therapy with a 3-drug all oral regimen of their protease+NNRTI+RBV & 47% in null responders, but this was not their best regimen, 24 weeks needs more exploration, and if we need 3 potent orals or even 4 potent orals not including RBV this will be studied and if perhaps some interferon for these patients are needed we will see that studied as well, as the hardest to treat are the cirrhotic, non-CC null responders. We have potent protease inhibitors, potent NS5A inhibitors, potent nucleotides and useful potent NNRTIs so there is a lot to work with.

EASL 47th Annual Meeting
Barcelona, Spain
April 18th - 22nd 2012

EASL: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)

EASL: A 12-Week Interferon-Free Regimen of ABT-450/r + ABT-333 + Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naïve HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders - (04/23/12)

EASL: A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects - (04/19/12)

EASL: Once Daily GS-7977 Plus Ribavirin in HCV Genotypes 1-3: The ELECTRON Trial - (04/21/12)

EASL: Gilead Announces Early Sustained Virologic Response Rates for GS-7977 Plus Ribavirin in Genotype 1 Treatment-Naïve Hepatitis C Patients - press release - (04/19/12)

EASL: Gilead Announces Sustained Virologic Response Data for 12-Week Regimen of GS-7977 Plus Pegylated Interferon and Ribavirin in Genotype 1 Hepatitis C Patients - press release - (04/19/12)

EASL: Dual Oral Therapy with NS5A Inhibitor Daclatasvir (BMS-790052) and NS3 Protease Inhibitor Asunaprevir (BMS-650032) in HCV Genotype 1b-Infected Null Responders or Patients Ineligible/Intolerant to Peginterferon/Ribavirin - (04/19/12)

EASL: SVR4 and SVR12 with an interferon-free regimen of BI 201335 AND BI 207127, +/- ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: Interim results of SOUND-C2 - (04/22/12)

EASL: The efficacy and safety of the interferon-free combination of BI 201335 and BI 207127 in genotype 1 HCV patients with cirrhosis: Interim analysis from SOUND-C2 - (04/20/12)

EASL: Gilead: Interim Sustained Virologic Response Rates in Treatment-Naïve HCV Genotype 1a and 1b Patients Treated for 12 or 24 Weeks with an Interferon-Free All-Oral Quad Regimen - (04/21/12)

EASL: Alisporivir plus ribavirin is highly effective as interferon-free or interferon-add-on regimen in previously untreated HCV-G2 or G3 patients: SVR12 results from VITAL-1 Phase 2b study - (04/22/12)
relevant studies


EASL: GS-7977 + PEG/RBV in HCV Genotype 1: The ATOMIC Trial An End To Response-Guided Therapy - (04/20/12)

EASL: TMC435 with peginterferon and ribavirin in treatment-experienced HCV genotype 1 patients: the ASPIRE study, a randomised Phase IIb trial - (04/19/12)

EASL: TMC435 in patients infected with HCV genotype 1 who have failed previous pegylated interferon / ribavirin treatment: Virologic analyses of the ASPIRE trial - (04/19/12)

EASL: Alisporivir (ALV) plus Peg-interferon/Ribavirin (PR) in HCV G1 Treatment-experienced Patients Achieves Primary Endpoint with Superior Efficacy at Treatment Week 12 Compared to Retreatment with PR - (04/22/12)

Chinese researchers eye anti-AIDS gel: molecule seems to block HIV from entering human cells


Scientists report they have discovered a molecule that blocks HIV from entering human cells (shutterstock.com)

Unprotected sex accounts for more than 90% infections in China, says researchers

Published: Tuesday, April 24, 2012, 11:39 AM Updated: Tuesday, April 24, 2012, 12:30 PM

Chinese researchers said Monday they have discovered an HIV-blocking agent that could be developed into a gel to limit the sexual transmission of AIDS.

Scientists from Hong Kong University said joint research with Shanghai Targetdrug Co., Nanjing University and City University of Hong Kong had discovered a molecule that blocks HIV from entering human cells.

Zhiwei Chen, director of the AIDS Institute of the University of Hong Kong Li Ka Shing Faculty of Medicine, said the potency of the TD-0680 molecule against sexually transmitted HIV was "encouraging."

The new molecule could be developed into a microbicide gel to "prevent HIV sexual transmission" by killing off the virus as it tries to enter the body.

This would give people, especially women, an "alternative method to protect themselves from the virus, in addition to condoms", Chen said.

"The ideal solution is to develop an effective vaccine. Since such a vaccine remains elusive, we must explore other strategies such as topical microbicide," he said.

The TD-0680 molecule is several times more potent than Maraviroc, a Pfizer-developed equivalent which has been approved by the Food and Drug Administration for clinical treatment, the Chinese scientists said.

Unprotected sex accounts for more than 90 percent of AIDS infections in China, the researchers said in a statement.

Their work was published recently in the peer-reviewed Journal of Biological Chemistry.


Nordion Announces Europe-Focused Phase III Clinical Trial for TheraSphere® Liver Cancer Treatment



April 24, 2012, 1:00 a.m. EDT

OTTAWA, April 24, 2012 /PRNewswire via COMTEX/ -- Study to evaluate and compare safety and efficacy of TheraSphere® vs. sorafenib in hepatocellular carcinoma patients with portal vein thrombosis

Nordion Inc.,a leading provider of products and services for the prevention, diagnosis and treatment of disease, today announced an additional randomized, multi-centre Phase III clinical trial for TheraSphere®, Nordion's yttrium-90 (Y-90) glass microsphere treatment for liver cancer.

The YES-P trial will be focused primarily in Europe, with additional locations to be identified globally, and is targeting enrolment of about 350 patients at approximately 24 sites. The trial will further evaluate the safety and efficacy of TheraSphere® in the treatment of patients with portal vein thrombosis (PVT) associated with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer.

PVT, a complication in which a clot forms in one of the blood vessels feeding the liver, occurs in approximately 30 to 40% of HCC cases. The presence of PVT is a contraindication for most embolic therapies, but TheraSphere® represents a safe alternative.

"Nordion is excited to directly address the important question of whether TheraSphere® can extend the lives of this sub-group of HCC patients, where typical life expectancy remains unacceptably low," said Mason Ross, MD, Nordion's Vice President of Medical Affairs. "YES-P is our first major clinical trial that will be primarily conducted in Europe, thus supporting our commitment to increase our global clinical research footprint while building on the knowledge of how TheraSphere® may improve survival compared to sorafenib."

The trial will follow a two-armed design. In one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere®, while patients in the other arm will receive sorafenib.

In the last 13 months, Nordion has also announced two additional Phase III clinical trials for TheraSphere®: STOP-HCC, involving patients with HCC, and EPOCH, involving patients with colorectal cancer whose disease has metastasized to the liver.

About TheraSphere®

TheraSphere® is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive Y-90. The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.

TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters.

In the US, TheraSphere® is used to treat patients with HCC who can have placement of appropriately positioned hepatic arterial catheters, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with partial or branch portal vein thrombosis or occlusion when clinical evaluation warrants the treatment. TheraSphere® is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere® package insert/instructions for use at www.nordion.com/therasphere .

About Nordion Inc.

Nordion Inc.is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at www.nordion.com and follow us at http://twitter.com/NordionInc .

SOURCE Nordion Inc.


Fibrosis and fatty liver disease increase risk of early atherosclerosis

Public release date: 24-Apr-2012

Contact: Dawn Peters

Italian researchers report that severe fibrosis increases the early atherosclerosis risk in patients with genotype 1 chronic hepatitis C virus (HCV) infection. A second study found that fatty liver disease also increases risk of developing atherosclerosis at an earlier period. Both studies appear in the May issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

In the first study, researchers led by Dr. Salvatore Petta from the Di.Bi.M.I.S. University of Palermo in Italy evaluated 174 patients with chronic HCV (genotype 1) along with 174 controls from an outpatient cardiology unit for signs of atherosclerosis. Ultrasonography was used to measure thickening of the carotid artery. Severity of fibrosis was determined for all HCV patients.

The team found carotid plaques in 42% of HCV patients compared to 23% of patients in the control group. Older age and severe liver fibrosis were independently associated with the presence of carotid plaque according to the authors. In patients 55 years or younger who had less sever fibrosis (stage F0-F2) only 22% had plaques in their artery compared to 52% with more sever fibrosis (stage F3-F4). Patients older the 55 years of age had similar prevalence of carotid lesions for those with or without severe fibrosis at 58% and 51% respectively.

"Our findings suggest that severe liver fibrosis places chronic HCV patients at higher risk of early atherosclerosis," said Dr. Petta. "This patient group should be carefully monitored to prevent progression of cardiovascular disease that is independent of their metabolic profile." The authors also caution that a majority of the European study participants were overweight, which should be considered in applying results to other patient populations.

A second study by Dr. Michaela Kozakova and colleagues from the University of Pisa further explored whether the association between fatty liver disease and early atherosclerosis is a consequence of shared conventional risk factors or is it determined by a specific circulating factor originating from liver or adipose tissue. For this purpose the researches investigated the association between the presence of early carotid plaques and the fatty liver index (FLI), which is an established surrogate marker for fatty liver disease based on body mass index (BMI), waist circumference, triglycerides and gamma glutamyltransferase (GGT), in subjects who were part of the multicenter European RISC (Relationship between Insulin Sensitivity and Cardiovascular risk) study group. For the present study, a subgroup of 1.012 RISC subjects who were free of hypertension, diabetes, cardiovascular diseases, chronic hepatic, inflammatory and neoplastic diseases, abnormal lipid levels, and metabolic syndrome were included.

In such a healthy population, only about 5% of subjects had small carotid plaques, and these subjects were older, had a FLI of 60 or more, and had higher blood pressure, LDL cholesterol, glucose, GGT and C-reactive protein than participants without plaques. In logistic regression model, after adjustment for conventional cardiovascular risk factors, family history, liver transaminase and alcohol consumption, the independent predictors of plaque presence were age, FLI of 60 or more and smoking habit. However, when FLI in the model was replaced by variables used in its equation the predictors of early atherosclerosis were age, GGT and smoking.

"Our cross-sectional study indicates that GGT may represent a link between fatty liver disease and development of early atherosclerosis," concludes Dr. Kozakova. On the basis of these results the authors suggest the GGT levels in the blood could be used as a biomarker of atherosclerosis.


Full Citations:Carotid Atherosclerosis and Chronic Hepatitis C: A Prospective Study of Risk Associations." Salvatore Petta, Daniele Torres, Giovanni Fazio, Calogero Cammà, Daniela Cabibi, Vito Di Marco, Anna Licata, Giulio Marchesini, Alessandra Mazzola,Gaspare Parrinello, Salvatore Novo, Giuseppe Licata and Antonio Craxì. Hepatology; April 4, 2012 (DOI: 10.1002/hep.25508); Print Issue Date: May 2012. http://onlinelibrary.wiley.com/doi/10.1002/hep.25508/abstract.

"Fatty Liver Index, Gamma-glutamyltransferase and Early Carotid Plaques." Michaela Kozakova, Carlo Palombo, Marco Paterni Eng, Jacqueline Dekker, Allan Flyvbjerg, Asimina Mitrakou, Amalia Gastaldelli, Ele Ferrannini and the RISC Investigators. Hepatology; Published Online: April 19, 2012 (DOI: 10.1002/hep.25555); Print Issue Date: May 2012. http://onlinelibrary.wiley.com/doi/10.1002/hep.25555/abstract.

Author Contact: Media representative at the University of Pisa is Dr. Roberta Filidei who can be reached at R.Filidei@adm.unipi.it. or 804-827-0890 begin_of_the_skype_highlighting 804-827-0890 end_of_the_skype_highlighting. Contacts at the University Hospital are Dr. Del Mauro and Dr. Zanotto who can be reached at ufficio.stampa@ao-pisa.toscana.it.

These studies are published in Hepatology. Media wishing to receive a PDF of the article may contact healthnews@wiley.com.

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Hepatology's current impact factor is 10.885.Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350.

About Wiley-Blackwell

Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit http://www.wileyblackwell.com or our new online platform, Wiley Online Library (http://www.wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.


Family history of liver cancer increases risk of developing the disease

Public release date: 24-Apr-2012

Contact: Dawn Peters

70-fold elevated risk of hepatocellular carcinoma in those with family history and hepatitis B or C markers

A family history of liver cancer is reported to increase risk of developing hepatocellular carcinomas (HCC), independent of hepatitis according to findings published in the May issue of Hepatology, a journal of the American Association for the Study of Liver Diseases. The study also shows 70-fold elevated risk of HCC in those with liver cancer in the family and markers for hepatitis B (HBV) or hepatitis C (HCV).

Liver cancer ranks sixth in incidence and the third cause of mortality worldwide. According to the World Health Organization (WHO) liver cancer was responsible for 700,000 deaths in 2008, with HBV and HCV accounting for 78% of all cases of HCC. A vaccine for HBV has been available since 1982; however prior studies have shown familial clustering of HCC in East Asia where HBV is common. While medical evidence reports family history to be related to HCC risk, little is known of this relationship in non-Asian populations.

"There is a high incidence of liver cancer in southern Italy which is likely a result of a higher frequency of HCV in this area," explains Professor Carlo La Vecchia from the Istituto di Ricerche Farmacologiche ''Mario Negri" and the University of Milan in Italy. "Our study investigated the relationship between family history and liver cancer in a Western population."

The case-control study was carried out between January 1999 and July 2002, and included 229 cases of HCC and 431 hospital controls. HCC patients ranged in age from 43 to 84 years, providing survey information and blood samples. The control group included patients admitted to hospital for conditions not related to tumors. Analysis of data on family history and liver cancer updated to April 2011 was also performed.

Results show that 75% of the cases and 11% of controls showed evidence of HBV and HCV infection. Family history of liver cancer was associated to HCC risk after adjusting for chronic HBV and HCV. Compared to subjects without family history of liver cancer and no chronic HBV and HCV, researchers reported an odds ratio of 73 for those with both risk factors, indicating a 70-fold increased risk of developing HCC.

"Our findings confirm that individuals with a positive family history of liver cancer have three times higher risk of developing HCC," notes Professor La Vecchia. "Monitoring individuals with family history, particularly those with hepatitis markers, could help to identify HCC at an earlier stage, and hence potentially reduce mortality from HCC."


Full Citation: Family History of Liver Cancer and Hepatocellular Carcinoma." Federica Turati, Valeria Edefonti, Renato Talamini, Monica Ferraroni, Matteo Malvezzi, Francesca Bravi, Silvia Franceschi, Maurizio Montella, Jerry Polesel, Antonella Zucchetto, Carlo La Vecchia, Eva Negri and Adriano Decarli. Hepatology; Published Online: March 21, 2012 (DOI: 10.1002/hep.24794); Print Issue Date: May 2012. http://onlinelibrary.wiley.com/doi/10.1002/hep.24794/abstract.

Author Contact: To arrange an interview with Professor La Vecchia, please contact Sergio Vicario with the University of Milan at svicario@metafora-mi.it or at +39 02 45485059.

This study is published in Hepatology. Media wishing to receive a PDF of the article may contact healthnews@wiley.com.

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Hepatology's current impact factor is 10.885.Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350.

About Wiley-Blackwell

Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit http://www.wileyblackwell.com or our new online platform, Wiley Online Library (http://www.wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.


Telaprevir May Cause Severe Cutaneous Eruptions

From Reuters Health Information

By Will Boggs MD

NEW YORK (Reuters Health) Apr 19 - The antiviral agent telaprevir (Incivek) has been associated with severe cutaneous eruptions, including the DRESS syndrome (drug reaction with eosinophilia and systemic symptoms), a new report warns.

"I would like physicians to be aware of DRESS occurring in patients on telaprevir-based therapy, as its effectiveness in hepatitis C is sure to make its use more ubiquitous in the future," Dr. Peggy A. Wu from Beth Israel Deaconess Medical Center, Boston, Massachusetts, told Reuters Health in an email. "Presentation tends to be later, around 3-12 weeks, and common symptoms include fever and extensive rash."

In the March 1 online issue of the Journal of Hepatology, Dr. Wu and Dr. Steven T. Chen reported on three patients out of 56 patients at risk (5%) who developed probable or definite DRESS during therapy with telaprevir, peginterferon, and ribavirin.

The three patients were a 60-year-old man in week seven of treatment, a 56-year-old woman who had completed seven weeks of treatment, and a 55-year-old woman who presented a week after completing 12 weeks of telaprevir therapy.

All three cases were managed successfully with discontinuation of medications, topical class I corticosteroids, and systemic antihistamines.

In phase II and III clinical trials involving over 3,800 patients, 3.7% of telaprevir-treated patients developed severe cutaneous adverse events, the researchers note. The U.S. Food and Drug Administration approved telaprevir for treating HCV infection on May 23, 2011 and included DRESS among its warnings and precautions.

"The most feared complication of DRESS is end-organ damage, which in extreme cases can be life-threatening," Dr. Wu said, "so it is important to identify the syndrome early to stop the offending medications and monitor the disease."

"These are observations from a single institution during a finite amount of time," she added. "More information is needed to determine the true incidence of DRESS in telaprevir-treated patients, their prognosis, risk factors, and optimal treatment."

At this point there are no standard measures for preventing DRESS, according to Dr. Wu. "Future studies may involve genotyping those who have DRESS on telaprevir-based therapy and screening patients with associated HLA type or slow metabolism prior to receiving the medication," she said. "Although testing for human herpes virus 6 reactivation is not commonly done in this country, its association with DRESS has been made in other countries, and it may be worth screening for in the future."

SOURCE: http://bit.ly/HJbDoq

J Hepatol 2012.


Aethlon Medical Note: An Unprecedented Data Point, The Single-Treatment Capture of Hepatitis C Virus (HCV) by the Aethlon Hemopurifier®



April 24, 2012, 9:30 a.m. EDT

SAN DIEGO, April 24, 2012 /PRNewswire via COMTEX/ -- Aethlon Medical, Inc., today released the following note authored by its Chairman and CEO, Jim Joyce.

The gold standard for determining drug therapy benefit against infectious disease targets is to measure changes in patient viral load, otherwise known as the amount of virus that is detectable in circulation. Specific to Hepatitis C virus (HCV), the best predictor of whether a treated patient will achieve a long-term viral cure is the period of time it takes to first achieve undetectable viral load. We recently disclosed that the administration of Hemopurifer® therapy during the first three days of peginterferon+ribavirin (PR) drug therapy resulted in observations of immediate (IVR) and rapid virologic responses (RVR) in hard-to-treat genotype-1 patients. IVR is a 2-log or 100 fold reduction of HCV viral load at day-7. Such a response correlates with 90+% viral cure rates, yet is observed in less than 5% of patients who receive PR therapy alone. RVR is defined as undetectable HCV viral load at day-30 of treatment and correlates with viral cure rates of 86.2%, which is observed in only 10.35% of patients who initiate PR therapy.

In this note, I will discuss an unprecedented data point that further validates the potential of Hemopurifier® therapy to improve the benefit of current interferon-based and emerging all-antiviral drug regimens. This same data point also provides further evidence that may help to explain our recent IVR and RVR treatment observations.

As the result of a collaborative discussion with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), our researchers initiated an effort to establish a protocol that would quantify the amount of HCV captured within our Hemopurifier® during a single treatment application. This would first entail a post-treatment preparation for each Hemopurifier®, which would then need to be frozen until ready for shipment on dry ice. This process is still being perfected as two of the first three cartridges analyzed were badly cracked. The next step was to establish a repeatable protocol methodology that would allow biological fluid to be eluted from within the Hemopurifier® so that PCR, the standard for measuring viral copies, could be utilized to validate and quantify the capture of HCV during treatment. The results were compelling.

In the two cracked cartridges referenced above, our researchers recovered and measured the capture of 145 million and 353 million copies of HCV. However, when the fully intact Hemopurifier® was analyzed, our researchers recovered and measured that 300 billion (300,000,000,000) copies of HCV had been captured during a single six-hour treatment. For those viruses captured, the possibility of continued progeny virus replication was eliminated. I applaud our research team for establishing this unprecedented data point, which defines the contribution our Hemopurifier® can provide to current and future HCV treatment regimens. Additionally, this data point serves as a model for capture capacity of other disease enhancing particles, whether they be associated with cancer, sepsis or other viral conditions.

About Aethlon Medical

The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT(TM) System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT(TM) product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome(TM) to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com .

Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT(TM) system including the ability to capture hepatitis c virus, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.


James A. JoyceChairman and CEO858.459.7800 x301jj@aethlonmedical.com

Jim FrakesChief Financial Officer858.459.7800 x300jfrakes@aethlonmedical.com

John P. SalvadorDirector, Communications858.459.7800 x307jps@aethlonmedical.com

SOURCE Aethlon Medical, Inc.


New Protease Inhibitor TMC435 Cures Most HCV Patients


From Medscape Medical News

Daniel M. Keller, PhD

April 24, 2012 (Barcelona, Spain) — In patients infected with hepatitis C virus (HCV) genotype 1 for whom previous treatment with pegylated interferon plus ribavirin (PR) failed to eliminate the virus, treatment with TMC435 plus PR was significantly more effective than PR plus placebo. TMC435 is a once-daily oral therapy that inhibits HCV NS3/4A protease.

Stefan Zeuzem, MD, professor of medicine and chief of the Department of Medicine I at the J.W. Goethe University Hospital in Frankfurt, Germany, presented the results of the international, double-blind, placebo-controlled phase 2b ASPIRE clinical trial here at The International Liver Congress 2012.

The 462 patients in this trial were assigned to 48 weeks of active therapy with 1 of 4 treatment regimens: TMC435 + PR for 12 weeks, followed by PR + placebo weeks for 36 weeks; TMC435 + PR for 24 weeks, followed by PR + placebo for 24 weeks; TMC435 + PR for 48 weeks; or PR + placebo for 48 weeks (control group).

In patients receiving TMC435, the dose was 100 or 150 mg daily. All patients were followed for 24 weeks after the 48-week treatment period.

Eligible men and women were 18 to 70 years of age, had a body weight of 40 to 125 kg, were chronically infected with HCV genotype 1 HCV, and had plasma HCV RNA greater than 10,000 IU/mL. They had to have received at least 1 previous course of PR for at least 12 consecutive weeks.

Patients were ineligible for the trial if they had decompensated liver disease or liver disease from any cause other than HCV; if they had hepatocellular carcinoma; if they were infected with HIV, hepatitis B virus, or any HCV that was not genotype 1; or if they had any laboratory or hematologic abnormalities.

At baseline, about two thirds of the patients were men, median age was about 50 years, body weight ranged from 80.0 to 84.8 kg, and 83% to 89% had HCV RNA greater than 800,000 IU/mL. Previously in each group, about 40% had relapsed, 35% had partially responded, and 25% had not responded.

In the 3 TMC435 groups (both the 100 and 150 mg doses), 53% to 68% of patients achieved rapid viral responses, compared with 2% in the control group (P < .001 for all groups vs control group). Rapid viral response meant there was undetectable virus in the blood at week 4.

The sustained viral response rates at 24 weeks (SVR24) ranged from 61% to 80% for the TMC435 groups, compared with 23% in the control group.

In the TMC435 groups, compared with the control group, previous responders had the highest SVR24 rates (85% vs 37%), followed by previous partial responders (57% to 75% vs 9%), followed by previous nonresponders (46% to 51% vs 19%).

No patients with advanced liver fibrosis achieved a virologic cure in the control group, whereas with TMC435, "there was a substantial chance for the patients to achieve sustained virologic response rates," Dr. Zeuzem reported.

TMC435 Well Tolerated

Discontinuation of treatment because of viral breakthrough was 9% to 17% in the TMC435 groups and 53% in the control group. Viral relapse occurred in 6% to 18% of the TMC435 group and 44% of the control group.

The incidence and severity of adverse events were similar in the TMC435 and control groups. Serious adverse events affected 6% to 10% of patients in the TMC435 groups and 6% in the control group. Grade 3/4 adverse events occurred in 28% to 36% of the TMC435 groups and in 26% of the control group. The most frequently reported adverse events in patients receiving TMC435 were headache, fatigue, and influenza-like illness, but these events were present at equivalent levels in the control group.

However, pruritus was more common in the TMC435 groups than in the control group (35% VS17%). Similarly, more rash of any type occurred in the TMC435 groups than in the control group (23% to 30% vs 18%). However, less than 1% of patients receiving TMC435 experienced rash of grade 3 or lower.

The incidence of adverse events leading to treatment discontinuation and serious adverse events was similar in all groups. Decreases in and recovery of hemoglobin values and neutrophil counts were equivalent in all groups. However, the TMC435 groups showed mild and reversible increases in bilirubin not accompanied by changes in any other liver parameters.

For patients receiving 150 mg of TMC435, 85% of previous relapsers achieved SVR24, 75% of previous partial responders achieved SVR24, 51% of previous nonresponders achieved SVR24, and 31% to 82% of patients with cirrhosis achieved SVR24.

Dr. Zeuzem and colleagues conclude that in patients with HCV genotype 1 who failed previous PR therapy, once-daily TMC435 plus PR was significantly more effective in producing a sustained viral response than PR plus placebo.

In comparing the different durations of administration of TMC435, Dr. Zeuzem explained that "TMC435 for 12 weeks in combination with pegylated interferon and ribavirin for 48 weeks achieves optimal biologic response rates." Longer treatment with TMC435 did not produce any better virologic responses.

The drug is now entering phase 3 trials for both treatment-naive and treatment-experienced patients.

Session moderator Mark Thursz, MBBS, MD, secretary general of the European Association for the Study of the Liver and professor of hepatology in the Department of Medicine at Imperial College, London, United Kingdom, asked Dr. Zeuzem if hepatologists need to continue to use SVR24 as the end point of a trial or if the follow-up period can be shortened by using sustained viral response at 12 weeks (SVR12) as the end point.

Dr. Zeuzem explained that current trials "typically use an SVR at week 12 of the follow-up period, and the concordance rates are extremely high [with SVR24]; therefore, SVR12 is the new standard."

He does not think there is a major difference between SVR12 and SVR24 for treatment-naive patients, nonresponders, or relapsers with an interferon-containing protocol such as this one. "I'm a little bit more conservative in trials using completely new drugs, [such as]...interferon-free regimens and all-oral regimens," Dr. Zeuzem said. He would like to see trials demonstrating the equivalence of SVR12 and SVR24 in those cases before adopting SVR12 for those drug regimens.

Dr. Thursz told Medscape Medical News that he, too, believes that SVR12 will be the new end point and will replace SVR24 as new drugs enter trials. "The only proviso is for people who've previously been treated and have been classified as null responders — that's a group of people with hepatitis C [in whom] the virus has not dropped by 2 logs [after 12 weeks of treatment]," he said. "These people are going to be really difficult to treat and very resistant to pretty much any kind of medication. I have some reservation about that group; otherwise, SVR12 is undoubtedly going to be, as it were, the standard."

Another group of particular concern is patients with advanced fibrosis or cirrhosis. "We know, certainly with interferon-based therapies, that response rates are much lower in that group. Then there is some concern in cirrhotics, particularly cirrhotics who've decompensated, that the metabolism of the drugs is going to be slightly different and may cause some problems," Dr. Thursz cautioned.

Dr. Zeuzem reports being a consultant for Abbott, Achillion, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead, Idenix, Inhibitex, iTherX, Janssen, Merck, Novartis, Presidio Pharmaceuticals, Roche, Santaris, and Vertx Pharmaceuticals. Dr. Thursz has disclosed no relevant financial relationships.

The International Liver Congress 2012: Abstract 2. Presented April 19, 2012.


Blood Basics

The Components of Blood and Their Importance

Blood Basics

Blood is a specialized body fluid. It has four main components: plasma, red blood cells, white blood cells, and platelets. Blood has many different functions, including:

  • transporting oxygen and nutrients to the lungs and tissues
  • forming blood clots to prevent excess blood loss
  • carrying cells and antibodies that fight infection
  • bringing waste products to the kidneys and liver, which filter and clean the blood
  • regulating body temperature
The blood that runs through the veins, arteries, and capillaries is known as whole blood, a mixture of about 55 percent plasma and 45 percent blood cells. About 7 to 8 percent of your total body weight is blood. An average-sized man has about 12 pints of blood in his body, and an average-sized woman has about 9 pints.

The Components of Blood and Their Importance

Many people have undergone blood tests or donated blood, but hematology – the study of blood – encompasses much more than this. Doctors who specialize in hematology (hematologists) are leading the many advances being made in the treatment and prevention of blood diseases. If you or someone you care about is diagnosed with a blood disorder, your primary care physician may refer you to a hematologist for further testing and treatment.


The liquid component of blood is called plasma, a mixture of water, sugar, fat, protein, and salts. The main job of the plasma is to transport blood cells throughout your body along with nutrients, waste products, antibodies, clotting proteins, chemical messengers such as hormones, and proteins that help maintain the body's fluid balance.

Red Blood Cells (also called erythrocytes or RBCs)

Known for their bright red color, red cells are the most abundant cell in the blood, accounting for about 40-45 percent of its volume. The shape of a red blood cell is a biconcave disk with a flattened center – in other words, both faces of the disc have shallow bowl-like indentations (a red blood cell looks like a donut).

Production of red blood cells is controlled by erythropoietin, a hormone produced primarily by the kidneys. Red blood cells start as immature cells in the bone marrow and after approximately seven days of maturation are released into the bloodstream. Unlike many other cells, red blood cells have no nucleus and can easily change shape, helping them fit through the various blood vessels in your body. However, while the lack of a nucleus makes a red blood cell more flexible, it also limits the life of the cell as it travels through the smallest blood vessels, damaging the cell’s membranes and depleting its energy supplies. The red blood cell survives on average only 120 days.

Red cells contain a special protein called hemoglobin, which helps carry oxygen from the lungs to the rest of the body and then returns carbon dioxide from the body to the lungs so it can be exhaled. Blood appears red because of the large number of red blood cells, which get their color from the hemoglobin. The percentage of whole blood volume that is made up of red blood cells is called the hematocrit and is a common measure of red blood cell levels.

White Blood Cells (also called leukocytes)

White blood cells protect the body from infection. They are much fewer in number than red blood cells, accounting for about 1 percent of your blood.

The most common type of white blood cell is the neutrophil, which is the “immediate response” cell and accounts for 55 to 70 percent of the total white blood cell count. Each neutrophil lives less than a day, so your bone marrow must constantly make new neutrophils to maintain protection against infection. Transfusion of neutrophils is generally not effective since they do not remain in the body for very long.

The other major type of white blood cell is a lymphocyte. There are two main populations of these cells. T lymphocytes help regulate the function of other immune cells and directly attack various infected cells and tumors. B lymphocytes make antibodies, which are proteins that specifically target bacteria, viruses, and other foreign materials.

Platelets (also called thrombocytes)

Unlike red and white blood cells, platelets are not actually cells but rather small fragments of cells. Platelets help the blood clotting process (or coagulation) by gathering at the site of an injury, sticking to the lining of the injured blood vessel, and forming a platform on which blood coagulation can occur. This results in the formation of a fibrin clot, which covers the wound and prevents blood from leaking out. Fibrin also forms the initial scaffolding upon which new tissue forms, thus promoting healing.

A higher than normal number of platelets can cause unnecessary clotting, which can lead to strokes and heart attacks; however, thanks to advances made in antiplatelet therapies, there are treatments available to help prevent these potentially fatal events. Conversely, lower than normal counts can lead to extensive bleeding.

Complete Blood Count (CBC)

A complete blood count (CBC) test gives your doctor important information about the types and numbers of cells in your blood, especially the red blood cells and their percentage (hematocrit) or protein content (hemoglobin), white blood cells, and platelets. The results of a CBC may diagnose conditions like anemia, infection, and other disorders. The platelet count and plasma clotting tests (prothombin time, partial thromboplastin time, and thrombin time) may be used to evaluate bleeding and clotting disorders.

Your doctor may also perform a blood smear, which is a way of looking at your blood cells under the microscope. In a normal blood smear, red blood cells will appear as regular, round cells with a pale center. Variations in the size or shape of these cells may suggest a blood disorder.

Normal blood smear.

The four larger cells shown are called granulocytes, a type of white blood cell.

Abnormal blood smear with variation in the size and color of the red blood cells.

Where Do Blood Cells Come From?

Blood cells develop from hematopoietic stem cells and are formed in the bone marrow through the highly regulated process of hematopoiesis. Hematopoietic stem cells are capable of transforming into red blood cells, white blood cells, and platelets. These stem cells can be found circulating in the blood and bone marrow in people of all ages, as well as in the umbilical cords of newborn babies. Stem cells from all three sources may be used to treat a variety of diseases, including leukemia, lymphoma, bone marrow failure, and various immune disorders.

Where Can I Find More Information?

If after further exploration of the Blood: The Vital Connection Web site you find that you are interested in learning more about blood diseases and disorders, here are a few other resources that may be of some help:

Articles From Hematology, the ASH Education Program Book
The American Society of Hematology (ASH) Education Book, updated yearly by experts in the field, is a collection of articles about the current treatment options available to patients. The articles are categorized here by disease type. If you are interested in learning more about a particular blood disease, we encourage you to share and discuss these articles with your doctor.

Results of Clinical Studies Published in Blood
Search Blood, the official journal of ASH, for the results of the latest blood research. While recent articles generally require a subscriber login, patients interested in viewing an access-controlled article in Blood may obtain a copy by e-mailing a request to the Blood Publishing Office.

Other Resources
This section includes a list of Web links to patient groups and other organizations that provide information.


INCIVEK™ (telaprevir) Now Funded for People With Hepatitis C in Quebec and Saskatchewan


April 24, 2012

- Vertex working with other provincial funding agencies to make INCIVEK available to more people in Canada -

LAVAL, Quebec--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the province of Quebec is now funding INCIVEK (telaprevir) tablets for residents living with chronic hepatitis C. The decision comes following a priority evaluation by the Institut National D'Excellence en Santé et en Services Sociaux (INESSS). This decision includes funding for patients who are being treated for the first time as well as those who were treated previously, but did not achieve a sustained virologic response (SVR, or virologic cure), including null responders. Null responders, or those who do not respond to initial treatment, have the hardest time achieving a cure. INCIVEK is the only direct-acting antiviral medicine approved for the treatment of this group of patients. Funding in Quebec will be provided for patients with all levels of fibrosis (scarring of the liver) and in combination with available pegylated-interferon and ribavirin combinations. Earlier this month, Saskatchewan became the first province in Canada to fund this new medicine. Vertex is working closely with other provincial reimbursement agencies to secure funding that will make INCIVEK accessible to more people with hepatitis C across all of Canada.

"In clinical studies, INCIVEK demonstrated the ability to cure nearly four out of five people infected by the hepatitis C genotype-1 virus who had not been previously treated for hepatitis C and to cut treatment time to 24 weeks for most patients, which marks a fundamental shift in treatment," said Dr. Marc Bilodeau from the Liver Unit of the Centre hospitalier de l'Université de Montréal. "The decision by the Minister of Health and Social Services of Quebec to reimburse INCIVEK underscores the urgent need for new medicines to treat this potentially life-threatening but curable disease, which affects about a quarter of a million people in Canada."

Health Canada approved INCIVEK for use in combination with pegylated-interferon and ribavirin in August 2011 for adults with genotype 1 chronic hepatitis C who have not received previous treatment or who failed a prior course of treatment with an interferon-based regimen. Vertex received a positive recommendation and criteria to list INCIVEK for reimbursement in February 2012 through Priority Review granted by the Common Drug Review (CDR). The approval was based on data from Phase 3 studies that showed significant improvements in rates of virologic cure among people with hepatitis C who were treated with INCIVEK combination therapy compared to pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:

People new to treatment: 79 per cent vs. 46 per cent

People who did not achieve a viral cure with previous treatment:

Relapsers: 86 per cent vs. 22 per cent

Partial responders: 59 per cent vs. 15 per cent

Null responders: 32 per cent vs. 5 per cent

Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.

"Direct-acting antivirals represent a major step forward in the treatment of hepatitis C," said Dr. Morris Sherman, Chairman of the Canadian Liver Foundation. "In order for this new class of medicines to make a significant impact however, they need to be accessible to all patients regardless of where they live, financial status or severity of their disease. The CLF has argued that to effectively treat hepatitis C, the medical community must have access to the most effective therapies in order to best meet the needs of their patients. We applaud Saskatchewan and Quebec for prioritizing the needs of hepatitis C patients and providing access to this new treatment option."

Eligibility criteria for treatment with INCIVEK in Quebec can be viewed online at: https://www.prod.ramq.gouv.qc.ca/DPI/PO/Commun/PDF/Liste_Med/Liste_Med/liste_med_2012_04_20_en.pdf

Eligibility criteria for treatment with INCIVEK in Saskatchewan under the Exception Drug Status program are available at: http://formulary.drugplan.health.gov.sk.ca/FormularyBulletins/Bulletin133Apr2012.pdf.

In addition, INCIVEK is currently accessible to Canadians through most private health insurers. Vertex has implemented a comprehensive patient support program called INCIVEK Care™ that is designed to coordinate reimbursement, provide financial assistance for costs associated with INCIVEK for people who meet certain program criteria and provide other support services related to treatment with INCIVEK.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1

Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 per cent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8

More than 170 million people worldwide are chronically infected with hepatitis C.6,9

Hepatitis C in Canada

Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected. 9 Quebec accounts for 16 per cent of hepatitis C infections in Canada, and 32,000 cases have been reported in Quebec since 1991.10,11 In 2009, 11,357 cases of hepatitis C were reported in Canada, and of that, 1,793 cases were reported in Quebec.9,11 In 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.12 By 2022, the number of hepatitis C-related deaths is expected to increase by one-third.13

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 2,000 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.

Vertex's press releases are available at www.vrtx.com.

About Vertex in Canada

In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex employs approximately 50 researchers and support staff in Laval. For more information on Vertex, including career opportunities with Vertex Canada, and to view Vertex's press releases, please visit the company's corporate website at www.vrtx.com.



1 Canadian Liver Foundation. Viral Hepatitis: What You Need to Know. Available at: http://www.liver.ca/hepatitis/hepatitis-c.aspx. Accessed April 20, 2012.

2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.

3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.

4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.

5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.

6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.

7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).

8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.

9 Public Health Agency of Canada. Hepatitis C: Get the facts. You could have it and not know it. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php. Updated September 21, 2010. Accessed March 21, 2012.

10 Public Health Agency of Canada. Modeling the incidence of prevalence of hepatitis C infection and its sequelae in Canada, 2007. http://www.phac-aspc.gc.ca/sti-its-surv-epi/model/results-eng.php. Updated October 20, 2010. Accessed March 21, 2012.

11 Sante et Services sociaux Quebec. Hepatitis C Virus. http://itss.gouv.qc.ca/?lg=en#/itss/hepatite_c. Accessed March 21, 2012.

12 Public Health Agency of Canada. A renewed public health response to address hepatitis C: A summary report of the priority-setting process and strategic framework to action. http://dsp-psd.pwgsc.gc.ca/collection_2010/aspc-phac/HP40-44-2009-eng.pdf. Updated June 2009. Accessed March 21, 2012.

13 Sherman M, Sharfran S, Burak K, et al. Management of chronic hepatitis C consensus guidelines. Can J Gastroenterol. 2007;21 (Suppl C):25C-34C.

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Source: Vertex Pharmaceuticals Incorporated