Peer Review Studies Find Decipher® Genomic Test Significantly Changes Postoperative Treatment Recommendations for Prostate Cancer Patients and Increases Confidence in Treatment Decisions

SAN DIEGO, May 14, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced data from two new clinical utility studies demonstrating that Decipher® Prostate Cancer Classifier significantly changed treatment decisions and increased confidence in treatment decision-making for men considering adjuvant therapy following prostate surgery. The studies are being published in upcoming issues of the journals Current Medical Research and Opinion (CMRO) and the British Journal of Urology International (BJUI), respectively.

"The American Urological Association has issued clinical guidelines recommending adjuvant radiation therapy to all prostate cancer patients with adverse pathology after surgery, despite that most men in this group did not develop metastasis or die of prostate cancer," noted John Hornberger, M.D., Principal of Cedar Associates, LLC, adjunct faculty at Stanford and senior author on the study published in CMRO. "By providing a more objective, individualized estimate of metastasis risk based on a quantitative laboratory assay, adoption of the Decipher prostate cancer test may reduce inappropriate or inconsistent use of adjuvant treatment in this population."

In the PRO-ACT study published in CMRO, 15 board-certified, community-based urologists who had ordered the Decipher test to inform management of their current patients were asked to provide treatment recommendations before and after receiving their patients' Decipher test results and then complete a decision conflict scale, a measure designed to assess confidence in treatment recommendations. Prior to receiving the Decipher test results, physicians were asked to make treatment decisions based on clinical risk factors such as Gleason score and tumor stage. Following the receipt of Decipher results, physicians changed their treatment recommendations for 30.8 percent of patients (95% CI, 23-39%). Among the 102 patients for whom observation was initially recommended, physicians changed recommendations to adjuvant radiation for 18 of those patients. Conversely, 17 of the 40 patients who were initially slated for adjuvant radiation saw recommendations change to observation. The genomic information provided by Decipher test results significantly influenced which patients were recommended adjuvant treatment (p<0.001). In addition, decisional conflict with regard to physicians' decision to treat with adjuvant radiation therapy was significantly less with the use of Decipher results than without (p<0.0001).

"Making secondary treatment decisions after our patients have had surgery is not cut and dry.  Most men who do not need additional treatment would prefer to avoid the side effects," said Ketan Badani, M.D., urologic oncologist at Columbia University in New York. "The ASSESS-D study clearly demonstrates that adding a test like Decipher, that gives physicians a readout of the genomic fingerprint of a patient's prostate cancer and provides a more precise measure of the biologic risk of developing metastasis, can help physicians make more appropriate treatment decisions, and be more confident in those decisions."

In the ASSESS-D study, a multi-center, prospective decision impact study published in BJUI, 51 community urologists reviewed and provided adjuvant treatment recommendations for randomly selected patient cases considered by clinical practice guidelines to be high risk for metastasis following prostate surgery.  Overall, 31 percent (95% CI: 27-35%) of treatment recommendations were changed after reviewing the Decipher results. Among adjuvant radiation therapy recommendations without Decipher results, 40% (n=77) changed to observation (95% CI: 33-47%) following knowledge of Decipher results. For patient cases recommended for observation, 13% (n=38) (95% CI: 9%-17%) were changed to adjuvant radiation therapy with Decipher. Case histories with low Decipher results were recommended observation 81% of the time (n=276), while for those with high Decipher results, 65% were recommended for treatment (n=118, p<0.0001). Treatment intensity was strongly correlated with the Decipher-predicted probability of metastasis (p<0.001) and the Decipher test was the dominant risk factor driving decisions in multivariable analysis (OR=8.6, 95% CI: 5.3-14.3%, p<0.0001).

About Decipher

The Decipher® Prostate Cancer Classifier directly measures a patient's biological risk of developing metastatic prostate cancer. By assessing the activity of multiple genomic markers associated with metastatic disease, Decipher provides information about the aggressiveness of a patient's tumor - information distinct from that provided by PSA and other clinical risk factors. Decipher continues to demonstrate that it can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer.

Decipher is covered by multiple private insurance plans and is available to eligible US patients through their physicians.  To learn more about ordering the Decipher test please visit www.deciphertest.com.

About GenomeDx Biosciences

GenomeDx Biosciences is focused on transforming patient management by putting usable genomic information in the hands of patients and their physicians. GenomeDx has developed the Decipher® Prostate Cancer Classifier, the first and only commercially available genomic test that predicts the risk of developing metastatic prostate cancer independently of PSA and other conventional risk assessment tools. GenomeDx is based in San Diego, California and Vancouver, British Columbia. To learn more visit www.genomedx.com

SOURCE GenomeDx Biosciences

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AbbVie Announces Initiation of Pivotal Phase III Study of Veliparib (ABT-888) for Patients with Non-Small Cell Lung Cancer

NORTH CHICAGO, Ill., April 15, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the initiation of a global Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The trial will compare patients randomized to receive either the standard chemotherapies of carboplatin and paclitaxel with the addition of veliparib, versus patients receiving carboplatin and paclitaxel with the addition of placebo.  

"Lung cancer is one of most common cancers worldwide and can be difficult to treat, particularly when it is diagnosed in the more advanced stages of the disease," said Scott Brun M.D., vice president, Pharmaceutical Development, AbbVie. "This Phase III trial is an important step in the development of veliparib and in potentially providing patients with squamous non-small cell lung cancer with a new treatment option."

This randomized, placebo-controlled, double-blind, multicenter, Phase III trial will recruit approximately 900 patients. The primary efficacy outcome of the trial is overall survival (OS). Other pre-specified outcome measures include progression-free survival (PFS), and objective response rate (ORR). The safety of veliparib will also be evaluated in the trial.

More information on the trial is available at www.clinicaltrials.gov (NCT02106546).

About Veliparib (ABT-888)
Veliparib (ABT-888) is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs damage to DNA, and contributes to chemotherapy resistance in cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumor types, including breast, ovarian, and non-small cell lung cancers.

About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85-to-90 percent of diagnosed cases.i There are three common subtypes of NSCLC: adenocarcinoma, squamous cell (epidermoid) carcinoma, and large cell (undifferentiated) carcinoma. Adenocarcinoma accounts for approximately 40 percent of lung cancers and is the most common form of NSCLC in patients who smoke, have smoked or have never smoked. Adenocarcinoma typically originates in the outer parts of the lung. Squamous cell carcinoma accounts for about 25-to-30 percent of NSCLC cases, and is usually found in the middle airways of the lungs. Squamous cell is often linked to patients with a history of smoking. About 10-to-15 percent of NSCLC cases are considered large cell carcinomas, which tend to grow and spread quickly, making it a more difficult-to-treat form of NSCLC. Other subtypes exist, but are less common.ii

Lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women. It accounts for about 13 percent of all new cancers in the U.S. and is the leading cause of cancer-related death among both men and women, causing more deaths than colon, breast, and prostate cancers combined.iii Worldwide, it is the most common form of cancer.iv Once NSCLC is diagnosed, treatment options can include surgery, radiation therapy, chemotherapy or targeted therapies, depending on the stage of the disease.v

About AbbVie Oncology
The fight against cancer is one of the greatest battles in medicine and the varied nature of the disease requires a diverse approach that looks at multiple disease targets in a variety of tumor types. AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories.  The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases.  AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries.  For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com.  Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

i "Non-Small Cell Lung Cancer." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/index?sitearea

ii "Non-Small Cell Lung Cancer: Detailed Guide." The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/index

iii "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics

iv "Lung Cancer Incidence Statistics." Cancer Research U.K., Accessed March 12, 2014: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/lung/incidence/uk-lung-cancer-incidence-statistics#geog

v "What Are the Key Statistics About Lung Cancer?" The American Cancer Society, Accessed March 12, 2014: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-treating-general-info

SOURCE AbbVie

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Laboratory-Grown Vaginas Implanted in Patients, Scientists Report

Wake Forest Baptist Medical Center logo. (PRNewsFoto/Wake Forest Baptist Medical Center HealthWire)jwplayer.key="2kY/GKwZ2uQZmDlQ9VYArfZt2b4+KhHX3+DM4zisgtE=";WINSTON-SALEM, N.C., April 11, 2014 /PRNewswire-USNewswire/ -- Scientists reported today the first human recipients of laboratory-grown vaginal organs. A research team led by Anthony Atala, M.D., director of Wake Forest Baptist Medical Center's Institute for Regenerative Medicine, describes in the Lancet long-term success in four teenage girls who received vaginal organs that were engineered with their own cells.

"This pilot study is the first to demonstrate that vaginal organs can be constructed in the lab and used successfully in humans," said Atala. "This may represent a new option for patients who require vaginal reconstructive surgeries. In addition, this study is one more example of how regenerative medicine strategies can be applied to a variety of tissues and organs."

The girls in the study were born with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome, a rare genetic condition in which the vagina and uterus are underdeveloped or absent. The treatment could also potentially be applied to patients with vaginal cancer or injuries, according to the researchers.

The girls were between 13 and 18 years old at the time of the surgeries, which were performed between June 2005 and October 2008. Data from annual follow-up visits show that even up to eight years after the surgeries, the organs had normal function.

"Tissue biopsies, MRI scans and internal exams using magnification all showed that the engineered vaginas were similar in makeup and function to native tissue, said Atlantida-Raya Rivera, lead author and director of the HIMFG Tissue Engineering Laboratory at the MRKH in Mexico City, where the surgeries were performed.

In addition, the patients' responses to a Female Sexual Function Index questionnaire showed they had normal sexual function after the treatment, including desire and pain-free intercourse.

The organ structures were engineered using muscle and epithelial cells (the cells that line the body's cavities) from a small biopsy of each patient's external genitals. In a Good Manufacturing Practices facility, the cells were extracted from the tissues, expanded and then placed on a biodegradable material that was hand-sewn into a vagina-like shape. These scaffolds were tailor-made to fit each patient.

About five to six weeks after the biopsy, surgeons created a canal in the patient's pelvis and sutured the scaffold to reproductive structures. Previous laboratory and clinical research in Atala's lab has shown that once cell-seeded scaffolds are implanted in the body, nerves and blood vessels form and the cells expand and form tissue. At the same time the scaffolding material is being absorbed by the body, the cells lay down materials to form a permanent support structure – gradually replacing the engineered scaffold with a new organ.

Followup testing on the lab-engineered vaginas showed the margin between native tissue and the engineered segments was indistinguishable and that the scaffold had developed into tri-layer vaginal tissue.

Current treatments for MRHK syndrome include dilation of existing tissue or reconstructive surgery to create new vaginal tissue. A variety of materials can be used to surgically construct a new vagina – from skin grafts to tissue that lines the abdominal cavity. However, these substitutes often lack a normal muscle layer and some patients can develop a narrowing or contracting of the vagina.

The researchers say that with conventional treatments, the overall complication rate is as high as 75 percent in pediatric patients, with the need for vaginal dilation due to narrowing being the most common complication.

Before beginning the pilot clinical study, Atala's team evaluated lab-built vaginas in mice and rabbits beginning in the early 1990s. In these studies, scientists discovered the importance of using cells on the scaffolds. Atala's team used a similar approach to engineer replacement bladders that were implanted in nine children beginning in 1998, becoming the first in the world to implant laboratory-grown organs in humans. The team has also successfully implanted lab-engineered urine tubes (urethras) into young boys.

The team said the current study is limited because of its size, and that it will be important to gain further clinical experience with the technique and to compare it with established surgical procedures.

Co-researchers were James J. Yoo, M.D., Ph.D., and Shay Soker, Ph.D., Wake Forest Baptist, and Diego R. Esquiliano M.D., Reyna Fierro-Pastrana P.hD., Esther Lopez-Bayghen Ph.D., Pedro Valencia M.D., and Ricardo Ordorica-Flores, M.D.,Children's Hospital Mexico Federico Gomez Metropolitan Autonomous University, Mexico.

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SOURCE Wake Forest Baptist Medical Center

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Cannabis Science (CBIS) Collaborates with Patients Out of Time, Inc., a Global Patient Advocacy Organization Dedicated to Educating Health Professionals and the Public about Therapeutic Cannabis

COLORADO SPRINGS, Colo., Feb. 5, 2014 /PRNewswire/ -- (NASD OTC: CBIS) Cannabis Science, Inc., a U.S. Company specializing in cannabis-based pharmaceutical development and related consulting operations, provides development consultation and financial support to Patients Out of Time, Inc., the premiere non-profit organization devoted to helping educate the public and healthcare professionals about the safety and effectiveness of medical cannabis. Cannabis Science is pleased to facilitate the critical work of this unique non-profit organization's ongoing conferences, events, workshops and global distribution of leading edge educational content and online resources.

CBIS's support includes supporting Patients Out of Time's marquee conference in Portland, Oregon in May 2014, entitled "The Eighth National Clinical Conference on Cannabis Therapeutics", and future conferences, helping to expand the organization's conferences from biennial to annual, for which participants or learners may earn ACCME (fully recognized continuing education) credits.

Patients Out of Time is a patient advocacy organization dedicated to educating health professionals and the public about therapeutic uses of cannabis. Incorporated in 1995, the organization is closely associated with leading research scientists on a global basis, medical and nursing professionals, and the four remaining patient participants in the federal government's Investigational New Drug (IND) program for cannabis.

"Attending Patients Out of Time's 2010 Conference led to my departure from the financial industry and my ongoing work in the medical cannabis industry.  I feel both lucky and blessed for that experience, as it taught me one of the most important lessons:  this industry is about patients and their health, not about getting high.  I like to say that it is not an accident that the first word in the organization's name is 'Patients'.   We look forward to the Portland conference in May, a conference that has become internationally renowned and a source of great pride for all involved," stated Robert Kane, Director and CFO of Cannabis Science.

About Cannabis Science, Inc.

Cannabis Science, Inc., takes advantage of its unique understanding of metabolic processes to provide novel treatment approaches to a number of illnesses for which current treatments and understanding remain unsatisfactory. Cannabinoids have an extensive history dating back thousands of years, and currently there are a growing number of peer-reviewed scientific publications that document the underlying biochemical pathways that cannabinoids modulate. The Company works with leading experts in drug development, medicinal characterization, and clinical research to develop, produce, and commercialize novel therapeutic approaches for the treatment for illnesses caused by infections as well as for age-related illness. Our initial focus is on skin cancers and neurological conditions.

Forward Looking Statements

This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing words such as "anticipate," "seek," intend," "believe," "estimate," "expect," "project," "plan," or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations regarding the use and development of cannabis-based drugs. Cannabis Science, Inc., does not undertake any duty nor does it intend to update the results of these forward-looking statements.

Cannabis Science, Inc.

Dr. Dorothy Bray, CEO & Director
dorothy.bray@cannabisscience.com
Tel: 1.888.777.0658
www.cannabisscience.com
info@cannabisscience.com

Investment Inquiries
Robert Kane, CFO & Director
robert.kane@cannabisscience.com
561.420.4824

SOURCE Cannabis Science, Inc.

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