News Article | June 12, 2017
TUCSON, Ariz.--(BUSINESS WIRE)--Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced today that an Independent Data Monitoring Committee (IDMC), following a planned interim futility analysis, recommended continuation of the company’s pivotal Phase 3 trial, CPP FAP-310, evaluating CPP-1X/sulindac for adults with familial adenomatous polyposis (FAP). FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. For most FAP patients, current medical practice recommends a lifetime of periodic monitoring as well as surgeries (FAP-related events). These FAP-related events include surgical removal of the colon, rectum, surgical pouch, duodenum, and/or high risk adenomas. “The IDMC’s recommendation to continue this ongoing pivotal Phase 3 clinical trial is an important win for FAP patients and an important clinical milestone for CPP,” said Jeff Jacob, Chair and CEO of the company. “We look forward to completing the trial and bringing to market a first-in-class pharmaco-prevention therapeutic.” The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. The ongoing trial has enrolled 171 patients at 17 research institutes in the United States, Canada, and Europe. Patients receive daily treatments of CPP-1X/sulindac or one of the single agents for at least two years, during which the time to the first occurrence of any FAP-related event is evaluated. The U.S. Food and Drug Administration (FDA) has granted CPP orphan drug designation for CPP-1X/sulindac for the treatment of FAP. The IDMC is an independent group of experts that monitors patient safety and other data and makes recommendations on continuation of the clinical trial based on its findings. For more information on the clinical trial (CPP FAP-310), please visit: https://clinicaltrials.gov/ct2/show/NCT01483144. Cancer Prevention Pharmaceuticals, Inc. (CPP) is developing therapeutics designed to reduce the risk of cancer and other diseases. CPP’s pharmaco-prevention approach has been used with success in other disease categories such as cardiovascular, neurovascular, and infectious disease. In addition to the CPP FAP-310 trial, CPP is co-sponsoring with the National Cancer Institute (NCI) and SWOG a large Phase 3 trial in colon cancer survivors. CPP is also working collaboratively with nonprofit groups to support their clinical trials in neuroblastoma, gastric cancer, and early-onset type 1 diabetes. CPP is located in Tucson, Arizona. For more information, please visit www.canprevent.com. This press release contains forward-looking statements on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “looks forward to,” and similar expressions. These statements are based upon our current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the expected completion of the Phase 3 trial and our intent to bring to market a first-in-class pharmaco-prevention therapeutic. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements including, among others, our ability to obtain the necessary regulatory approvals for commercialization of our therapeutics, our ability to commence or complete our clinical trials and those of our investigators on time or to achieve desired results, our ability to receive anticipated funding, our ability to successfully develop, market or sell our products, or our ability to maintain our material licensing agreements. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
News Article | July 17, 2017
TUCSON, Ariz.--(BUSINESS WIRE)--Cancer Prevention Pharmaceuticals, Inc. (“CPP”) announced today the launch of a Phase 2 clinical trial at Vanderbilt University Medical Center to evaluate CPP-1X in patients with precancerous gastric lesions who are at high risk for gastric cancer. The trial is funded by the National Cancer Institute (NCI) and run in collaboration with Keith T. Wilson, M.D., and Douglas R. Morgan, M.D., MPH, of Vanderbilt University School of Medicine, Vanderbilt University Medical Center, and the Vanderbilt-Ingram Cancer Center. This randomized, double-blind, placebo-controlled pharmaco-prevention trial will enroll 300 patients. Each patient will receive daily treatment for 18 months to determine the drug’s effectiveness in ameliorating DNA damage in patients with premalignant atrophic gastritis or intestinal metaplasia. This trial is an initial step in a program to determine if CPP-1X can prevent gastric cancer. In 2015, CPP received Orphan Drug Designation for CPP-1X for the treatment of gastric cancer including cancer of the gastroesophageal junction from the U.S. Food and Drug Administration (FDA). CPP was also granted orphan designation in familial adenomatous polyposis and neuroblastoma in the United States and European Union. “Our mission is to develop new therapeutics that focus on the prevention of cancer and its recurrence,” said Jeffrey Jacob, CEO of CPP. “We are pleased to collaborate with the NCI and leaders in gastric cancer prevention at Vanderbilt University to evaluate the potential of CPP-1X in reducing the progression of precancerous lesions in high-risk patients, and thereby help prevent gastric cancer.” “Currently there are no agents for the prevention of gastric cancer in patients with precancerous conditions of the stomach,” said Dr. Wilson. “Gastric cancer, which is also known as stomach cancer, is the third leading cause of cancer-related deaths in the world, and we need prevention options for these patients,” added Dr. Morgan. The American Cancer Society estimates the incidence of stomach cancer in the United States in 2015 to be about 24,590 cases, and about 10,720 people will die from this type of cancer this year. CPP’s pharma partners have certain rights to CPP’s combination product CPP-1X/sulindac. CPP-1X as a standalone therapy is owned exclusively by CPP. CPP is developing therapeutics that reduce the risk of cancer. CPP’s approach has been used with great success in other disease categories such as cardiovascular, neurovascular and infectious disease. Agents that target pre-disease states have helped reduce death rates from these conditions by 50%-70% over the past 30 years. Just as these other prevention therapies represent the largest-selling drug classes on the market today, CPP believes there is even more potential for therapies that reduce the risk of cancer. In addition to this Phase II gastric cancer trial, CPP is sponsoring a large Phase III trial in colon cancer survivors and a Phase III trial for familial adenomatous polyposis (FAP), a disease that causes hundreds to thousands of colon polyps, and has a 100% risk of colon cancer unless treated by surgical removal of the colon/rectum. CPP is also working collaboratively with clinical collaborators to support trials in neuroblastoma—treating and preventing relapse. Additional information on CPP is available at www.canprevent.com. About Vanderbilt University Medical Center and the Vanderbilt-Ingram Cancer Center Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated to patient care, research, and biomedical education. Its reputation for excellence in each of these areas has made Vanderbilt a major patient referral center for the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt for their health care needs, not only because of its excellence in medical science, but also because the faculty and staff are dedicated to treating patients with dignity and compassion. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research. Vanderbilt-Ingram Cancer Center (VICC) is one of only two National Cancer Institute-designated Comprehensive Cancer Centers in Tennessee and 47 in the country to achieve this special distinction. Its 300 faculty members generate more than $140 million in annual federal research funding, ranking it among the top 10 centers in the country in competitive grant support, and its clinical program sees more than 6,000 new cancer patients each year. VICC is a member of the National Comprehensive Cancer Network, a non-profit alliance of the world’s leading cancer centers dedicated to improving cancer care for patients everywhere. This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the planned Phase II trial of the CPP-1X therapy as well as the company's focus, collaborative partners, and independent and partnered product candidates. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Allott E.H.,Duke University |
Allott E.H.,Cancer Prevention Pharmaceuticals |
Allott E.H.,Veterans Affairs Medical Center Durham |
Howard L.E.,Duke University |
And 10 more authors.
Cancer Epidemiology Biomarkers and Prevention | Year: 2014
Background: Evidence for an association between total cholesterol, low- and high-density lipoproteins (LDL and HDL, respectively), triglycerides, and prostate cancer is conflicting. Given that prostate cancer and dyslipidemia affect large proportions of Western society, understanding these associations has public health importance. Methods: We conducted a retrospective cohort analysis of 843 radical prostatectomy (RP) patients who never used statins before surgery within the Shared Equal Access Regional Cancer Hospital (SEARCH) database. Multivariable Cox proportional hazards analysis was used to investigate the association between cholesterol, LDL, HDL, and triglycerides and biochemical recurrence risk. In secondary analysis, we explored these associations in patients with dyslipidemia, defined using National Cholesterol Education Program guidelines. Results: Elevated serum triglycerides were associated with increased risk of prostate cancer recurrence [HRper 10 mg/dl, 1.03; 95% confidence interval (CI), 1.01-1.05] but associations between total cholesterol, LDL and HDL, and recurrence risk were null. However, among men with dyslipidemia, each 10 mg/dl increase in cholesterol and HDL was associated with 9% increased recurrence risk (HR, 1.09; 95% CI, 1.01-1.17) and 39% reduced recurrence risk (HR, 0.61; 95% CI, 0.41-0.91), respectively. Conclusions: Elevated serum triglycerides were associated with increased risk of prostate cancer recurrence. Cholesterol, LDL, or HDL were not associated with recurrence risk among all men. However, among men with dyslipidemia, elevated cholesterol and HDL levels were associated with increased and decreased risk of recurrence, respectively. Impact: These findings, coupled with evidence that statin use is associated with reduced recurrence risk, suggest that lipid levels should be explored as a modifiable risk factor for prostate cancer recurrence. ©2014 AACR.
Allott E.H.,Duke University |
Howard L.E.,Duke University |
Howard L.E.,Cancer Prevention Pharmaceuticals |
Cooperberg M.R.,Veterans Affairs Medical Center |
And 8 more authors.
BJU International | Year: 2014
Objective To investigate the effect of statin use after radical prostatectomy (RP) on biochemical recurrence (BCR) in patients with prostate cancer who never received statins before RP. Patients and Methods We conducted a retrospective analysis of 1146 RP patients within the Shared Equal Access Regional Cancer Hospital (SEARCH) database. Multivariable Cox proportional hazards analyses were used to examine differences in risk of BCR between post-RP statin users vs nonusers. To account for varying start dates and duration of statin use during follow-up, post-RP statin use was treated as a time-dependent variable. In a secondary analysis, models were stratified by race to examine the association of post-RP statin use with BCR among black and non-black men. Results After adjusting for clinical and pathological characteristics, post-RP statin use was significantly associated with 36% reduced risk of BCR (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.47-0.87; P = 0.004). Post-RP statin use remained associated with reduced risk of BCR after adjusting for preoperative serum cholesterol levels. In secondary analysis, after stratification by race, this protective association was significant in non-black (HR 0.49, 95% CI 0.32-0.75; P = 0.001) but not black men (HR 0.82, 95% CI 0.53-1.28; P = 0.384). Conclusion In this retrospective cohort of men undergoing RP, post-RP statin use was significantly associated with reduced risk of BCR. Whether the association between post-RP statin use and BCR differs by race requires further study. Given these findings, coupled with other studies suggesting that statins may reduce risk of advanced prostate cancer, randomised controlled trials are warranted to formally test the hypothesis that statins slow prostate cancer progression. © 2014 The Authors. BJU International © 2014 BJU International.
News Article | December 9, 2016
— Neuroblastoma Pipeline Market Companies Involved in Therapeutics Development are Ability Pharmaceuticals SL, Acetylon Pharmaceuticals Inc, Advanced Accelerator Applications SA, Alissa Pharma, Ampio Pharmaceuticals Inc, APEIRON Biologics AG, AstraZeneca Plc, Bayer AG, Bellicum Pharmaceuticals Inc, Bexion Pharmaceuticals LLC, BioLineRx Ltd, Bionucleon Srl, Biotec Pharmacon ASA, Cancer Prevention Pharmaceuticals, Inc., Cebiotex SL, Celgene Corp, Cielo Therapeutics Inc, Cleveland BioLabs Inc, Codagenix, Inc., CorMedix Inc, Curis Inc, Cyclacel Pharmaceuticals Inc, DEKK-TEC Inc, EnGeneIC Ltd, Errant Gene Therapeutics LLC, F. Hoffmann-La Roche Ltd, GlaxoSmithKline Plc, Green Cross Cell Corp, Ignyta Inc, Incuron, LLC, Juno Therapeutics Inc, Kolltan Pharmaceuticals Inc, Lindis Biotech GmbH, MabVax Therapeutics Holdings Inc, MediaPharma srl, Merck & Co Inc, Merrimack Pharmaceuticals Inc, Morphogenesis Inc, Novartis AG, Novogen Ltd, OGD2 Pharma SAS, Pfizer Inc, Pharmacyclics Inc, Progenics Pharmaceuticals Inc, ProNAi Therapeutics Inc, Recombio SL, Ribomic Inc., Sapience Therapeutics Inc, Sareum Holdings Plc, Shionogi & Co Ltd, Syros Pharmaceuticals Inc and Tiltan Pharma Ltd. Neuroblastoma is the cancer of the nerve tissues and neural crest cells of adrenal glands, neck, chest or spinal cord, occurring predominantly in children. It usually begins in the adrenal glands further spreading to other parts of the body. The predisposing factors involved in neuroblastoma include genetic conditions. Symptoms include lump in abdomen or chest, weakness, bone pain, breathing problems, dark circles around the eyes and difficulty in movement. The condition may be diagnosed by X-ray imaging, CT scan, MRI, biopsy, urine test, etc. It may be controlled by chemotherapy, radiation therapy, stem cell transplants and medication such as monoclonal antibody regimens. This research provides comprehensive information on the therapeutics under development for Neuroblastoma (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Inquire more about this research report at http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=774100 The Neuroblastoma (Oncology) pipeline guide also reviews of key players involved in therapeutic development for Neuroblastoma and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical and Discovery stages are 1, 1, 15, 15, 1, 43 and 4 respectively. Similarly, the Universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 8, 7, 9 and 4 molecules, respectively. Neuroblastoma (Oncology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Buy a copy of this research report at http://www.reportsnreports.com/purchase.aspx?name=774100 • The pipeline guide provides a snapshot of the global therapeutic landscape of Neuroblastoma (Oncology). • The pipeline guide reviews pipeline therapeutics for Neuroblastoma (Oncology) by companies and universities/research institutes based on information derived from company and industry-specific sources. • The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. • The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. • The pipeline guide reviews key companies involved in Neuroblastoma (Oncology) therapeutics and enlists all their major and minor projects. • The pipeline guide evaluates Neuroblastoma (Oncology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. • The pipeline guide encapsulates all the dormant and discontinued pipeline projects. • The pipeline guide reviews latest news related to pipeline therapeutics for Neuroblastoma (Oncology) • Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. • Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. • Find and recognize significant and varied types of therapeutics under development for Neuroblastoma (Oncology). • Classify potential new clients or partners in the target demographic. • Develop tactical initiatives by understanding the focus areas of leading companies. • Plan mergers and acquisitions meritoriously by identifying key players and its most promising pipeline therapeutics. • Formulate corrective measures for pipeline projects by understanding Neuroblastoma (Oncology) pipeline depth and focus of Indication therapeutics. • Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope. • Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. For more information, please visit http://www.reportsnreports.com/reports/774100-neuroblastoma-pipeline-review-h2-2016.html
Pollak K.I.,Cancer Prevention Pharmaceuticals |
Pollak K.I.,Duke University |
Lyna P.,Cancer Prevention Pharmaceuticals |
Bilheimer A.,Cancer Prevention Pharmaceuticals |
And 4 more authors.
Nicotine and Tobacco Research | Year: 2013
Introduction: Smoking during pregnancy causes multiple perinatal complications; yet, the smoking rate among pregnant women has remained relatively stagnant. Most interventions to help pregnant smokers quit or reduce their smoking are not easily disseminable. Innovative and disseminable interventions are needed. Methods: We recruited 31 pregnant smokers in their second trimester from prenatal clinics. We assessed feasibility, acceptability, and preliminary efficacy of an SMS text-based intervention in a 2-arm design. We compared SMS-delivered support messages to an intervention that provided support messages plus a scheduled gradual reduction (SGR) to help women reduce their smoking more than 3 weeks. We sent women in the SGR arm "alert texts" at times to instruct them to smoke. We asked women not to smoke unless they received an alert text. Results: Most women (86%) reported reading most or all of the texts. Women in both arms rated the program as helpful (M = 6, SD = 1 vs. M = 5, SD = 2, SGR vs. support only, respectively). Women in the SGR arm had a higher rate of biochemically validated 7-day point prevalence at the end of pregnancy 13.4% versus 7.5%. Of those still smoking, women reduced their smoking substantially with more reduction in the SGR arm (SGR arm: M = 16, SD = 11 vs. support messages only: M = 12, SD = 7). Conclusions: We developed an easily disseminable intervention that could possibly promote cessation and reduction among pregnant women with SMS texting ability. Women in this pilot were enthusiastic about the program, particularly those in the SGR arm. This program needs further examination. © The Author 2013. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.
Reinau D.,University of Basel |
Meier C.,University of Basel |
Meier C.,Boston University |
Gerber N.,Cancer Prevention Pharmaceuticals |
And 2 more authors.
Swiss Medical Weekly | Year: 2012
BACKGROUND: The skin cancer incidence in Switzerland is one of the highest in Europe and still on the rise. Sun protection is the main preventive measure and of utmost importance during childhood and adolescence, since sunburns within these early phases of life increase the risk of developing skin cancer in adulthood. OBJECTIVES: The aim of this prospective study, the first of its kind in Switzerland, was to investigate the sun protective behaviour of primary and secondary school students in Basel (North-Western Switzerland) and to test their knowledge about adverse health effects of solar radiation and about protective measures. METHODS: Between March and April 2010, supervised classroom surveys during regular school lessons were conducted in 13 public schools using a multiple-choice questionnaire. 960 questionnaires were handed out to 48 school classes. Descriptive statistics and logistic regression analyses were performed on the data of 887 (>90%) students from three different grades (3 rd, 6 th and 9 th grade). RESULTS: Sun-related knowledge was high in one third of all respondents only and significantly depended on student's age and educational background. Although the oldest students reached the highest knowledge scores, they protected themselves the least from the sun. Sunscreen was the principal form of sun protection mentioned, but was insufficiently applied. Seeking shade and wearing clothing as protective measures were hardly used. High educational background (i.e., of the parents) was a determinant for routine use of sunscreen but was not associated with following other sun protective measures. The desire for a suntan had no impact on the use of sunscreen, but was a significant predictor for not seeking shade and wearing shoulderless shirts when in the sun. More than half of all study participants experienced at least one sunburn during the year preceding the survey. Fair skin type, higher grade, not seeking shade and wearing shoulderless shirts were directly associated with increased odds of sunburn. No association was found for the use of sunscreen and the occurrence of sunburn. CONCLUSIONS: In order to reduce the incidence of skin cancer in Switzerland, it is essential to improve children's and adolescents' sun protective behaviour. Future skin cancer prevention campaigns should teach proper use of sunscreen, and emphasise the value of wearing clothing and seeking shade as the most effective sun protection. Furthermore, major efforts are needed to change adolescents' attitude towards a suntan.
Cancer Prevention Pharmaceuticals and Regent University | Date: 2011-05-13
Controlling exogenous polyamines may be used, in some aspects, as an adjunctive strategy to chemoprevention with polyamine inhibitory agents, for example, anti-carcinoma combination therapies comprising ornithine decarboxylase (ODC) inhibitor and a spermidine/spermine N^(1)-acetyltransferase expression agonist, optionally based on a patients ODC1 promoter genotype. Assessing a tissue polyamine level or tissue polyamine flux may be used in some aspects, for predicting the efficacy of an anti-carcinoma combination therapy comprising, for example, an ornithine decarboxylase (ODC) inhibitor and an agent that modulates the polyamine pathway to reduce overall cellular polyamine content.
Reinau D.,University of Basel |
Meier C.R.,University of Basel |
Meier C.R.,Boston University |
Gerber N.,Cancer Prevention Pharmaceuticals |
Surber C.,University of Basel
European Journal of Cancer Prevention | Year: 2014
The incidence of skin cancer has increased worldwide, with rates being especially high in Switzerland compared with other European countries. Extensive sun exposure during childhood is considered a key factor for skin carcinogenesis. The aim of the study was to evaluate the impact of a school-based sun safety education programme developed by the Swiss Cancer Leagues on primary school students' sun-related knowledge, protective behaviours and sunburn rates. In summer 2011, 1-h sun safety education sessions were held at 33 primary schools throughout the Canton of Zurich (North-Eastern Switzerland). Children in the participating school classes (first, second and third graders) answered a questionnaire on their sun-related knowledge, behaviours and sunburn experience shortly before and 1 year after the intervention. Overall, 3110 completed pretest and 1738 post-test questionnaires were eligible for analysis. The evaluation of pretest data showed considerable room for improvement in terms of sun-related knowledge, considering that merely a good half of the children were conscious that the sun may present a hazard to health. Overall, more than 95% of students benefited from the protection of sunscreen (application by parents: 73%; application by child: 66%), but only 36% stated that they generally sought shade on sunny days. After the intervention, knowledge increased considerably and significantly (P<0.0001), but there was no change in sun-protective behaviours (use of sunscreen, seeking shade). However, we observed a nonsignificant trend towards decreased sunburn rates. The brief one-time sun safety education sessions were effective in sustainably improving children's sun-related knowledge and possibly to some extent in decreasing their sunburn rates. Copyright © Lippincott Williams & Wilkins.