The Salk Institute embodies Jonas Salk’s mission to dare to make dreams into reality. We explore the very foundations of life, seeking new realities in neuroscience, genetics, immunology and more. We are small by choice, intimate by nature, fearless […
SAN DIEGO, May 23, 2016 /PRNewswire/ — Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced the appointment of Deborah A. Jorn to its Board of Directors, effective immediately. The Company also announced Dr. Preston Klassen has resigned to pursue other interests in drug development with a private company. Peter Flynn, PhD has been appointed as Senior Vice President, Head of Development, Regulatory Affairs and Safety, while Toni Foster will continue in her role as Senior Vice President, Project Management Office and Clinical Operations.
Jorn is a senior commercial strategist with a more than 30 year history of building multi-billion dollar global pharmaceutical businesses and a proven track record of designing and implementing innovative business and marketing strategies that have consistently delivered double-digit organic growth across numerous therapeutic areas. Jorn is the former Executive Vice President and Group Company Chair at Valeant Pharmaceuticals and was responsible for Valeant’s two largest business units, Dermatology and Gastroenterology, and led a marketing and sales organization encompassing over 1,100 team members. Prior to Valeant, she was the Chief Global Marketing Officer at Bausch and Lomb Pharmaceuticals and served as the commercial head of their $1.3 billion Global Pharmaceutical Division which included both Rx and OTC brands. She also served in senior commercial leadership roles at Schering Plough, Johnson & Johnson, and Pharmacia. Jorn received a MBA from the Stern Graduate School of Business Administration at New York University and a BA in Biochemistry from Rutgers University.
“We are pleased to have Deb Jorn join Orexigen’s Board of Directors. Deb’s extensive biopharmaceutical management experience, including brand strategy and consumer marketing, will be an asset to the Company as we advance our plans for Contrave® and Mysimba® in the U.S. and around the world,” said Mike Narachi, President and Chief Executive Officer.
Flynn and Foster will each report to Orexigen Chief Executive Mike Narachi. Flynn, who joined Orexigen in 2014, has more than 15 years of experience in biopharmaceutical research and development. Foster, with nearly 25 years of deep experience in clinical trial conduct and operations, joined Orexigen in 2012 and previously managed the enrollment and overall conduct of the Light Study cardiovascular outcomes trial.
“Preston has played an instrumental role in obtaining U.S. and European approvals for Contrave / Mysimba and has made many valuable contributions to Orexigen over the last seven years. We wish him every success in his new endeavors,” Narachi said. “Toni Foster and Pete Flynn are industry veterans who will provide strong and seamless leadership of the development, regulatory affairs, safety and clinical operations functions at Orexigen.”
About CONTRAVE® (naltrexone HCl and bupropion HCl extended release)
CONTRAVE, approved by the United States Food and Drug Administration in September 2014, is indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).
The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood. CONTRAVE has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of CONTRAVE in conjunction with lifestyle modification in 4,536 subjects randomized to CONTRAVE or placebo. In these studies, the most common adverse reactions (>5 percent) seen in patients taking CONTRAVE included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
Important Safety Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
Suicidality and Antidepressant Drugs
CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.
Neuropsychiatric Reactions in Patients Taking Bupropion for Smoking Cessation
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although CONTRAVE is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.
CONTRAVE is contraindicated in: uncontrolled hypertension; seizure disorder or a history of seizures; use of other bupropion-containing products; bulimia or anorexia nervosa, which increase the risk for seizure; chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal; patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; use during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs)—there is an increased risk of hypertensive reactions when CONTRAVE is used concomitantly with MAOIs and use with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated; known allergy to any component of CONTRAVE anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; pregnancy.
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. This warning applies to CONTRAVE because one of its components, bupropion, is a member of an antidepressant class.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of anxiety, agitation, irritability, unusual changes in behavior, and other symptoms, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for CONTRAVE should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
CONTRAVE is not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur.
CONTRAVE can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Caution should be used when prescribing CONTRAVE to patients with predisposing factors that may increase the risk of seizure, including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives; patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia; concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, systemic steroids.
Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations, in particular: the total daily dose of CONTRAVE does not exceed 360 mg of the bupropion component (i.e., four tablets per day); the daily dose is administered in divided doses (twice daily); the dose is escalated gradually; no more than two tablets are taken at one time; coadministration of CONTRAVE with high-fat meals is avoided; if a dose is missed, a patient should wait until the next scheduled dose to resume the regular dosing schedule.
Patients Receiving Opioid Analgesics
Vulnerability to Opioid Overdose: CONTRAVE should not be administered to patients receiving chronic opioids, due to the naltrexone component, which is an opioid receptor antagonist. If chronic opiate therapy is required, CONTRAVE treatment should be stopped. In patients requiring intermittent opiate treatment, CONTRAVE therapy should be temporarily discontinued and lower doses of opioids may be needed. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after CONTRAVE treatment is discontinued. An attempt by a patient to overcome any naltrexone opioid blockade by administering large amounts of exogenous opioids is especially dangerous and may lead to a fatal overdose or life-threatening opioid intoxication (e.g., respiratory arrest, circulatory collapse). Patients should be told of the serious consequences of trying to overcome the opioid blockade.
Precipitated Opioid Withdrawal: An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids, and those patients transitioning from buprenorphine or methadone may need as long as two weeks. Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use.
Increase in Blood Pressure (BP) and Heart Rate (HR)
CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. These events were observed in both patients with and without evidence of preexisting hypertension. In clinical practice with other bupropion-containing products, hypertension, in some cases severe and requiring acute treatment, has been reported. Blood pressure and pulse should be measured prior to starting therapy with CONTRAVE and should be monitored at regular intervals consistent with usual clinical practice, particularly among patients with cardiac or cerebrovascular disease and/or with controlled hypertension prior to treatment.
Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock. Instruct patients to discontinue CONTRAVE and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus, hives, chest pain, edema, or shortness of breath) during this treatment.
Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis.
Activation of Mania
Bupropion, a component of CONTRAVE, is a drug used for the treatment of depression. Antidepressant treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). CONTRAVE is not approved for use in treating bipolar depression.
The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hypoglycemia with Use of Antidiabetic Medications
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas). Measurement of blood glucose levels prior to starting CONTRAVE and during CONTRAVE treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.
Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).
Increased risk of hypertensive reactions can occur when CONTRAVE is used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause false positive urine test results for amphetamines.
CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
* 30 kg/m2 or greater (obese) or
* 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs and over-the-counter drugs, and herbal preparations, have not been established.
Please see accompanying full Prescribing Information and Medication Guide for CONTRAVE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
CONTRAVE® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. All other trademarks are the property of their respective owners.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen’s first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the United States in September 2014 and became the most prescribed branded obesity medication in the United States in June 2015. In Europe, the drug has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged release). Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring Contrave / Mysimba to patients around the world. Further information about Orexigen can be found at www.orexigen.com
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on our current beliefs and expectations. These forward-looking statements include statements regarding: Orexigen’s assumption of the commercialization of Contrave in the United States later this year and the launch of an effective and efficient U.S. commercial organization to drive the next phase of growth for Contrave. The inclusion of forward looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the potential that the marketing and commercialization of Contrave will not be successful; additional analysis of the interim results or the final data from the terminated Light Study, including safety-related data, and the additional CVOT may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; Orexigen’s ability to obtain and maintain global intellectual property protection for Contrave; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; the therapeutic and commercial value of Contrave; Orexigen’s ability to maintain sufficient capital to fund its operations for the foreseeable future; estimates of the capacity of manufacturing and other facilities to support Contrave; the potential for a Delaware court to determine that one or more of the patents are not valid or that Actavis’ proposed generic product is not infringing each of the patents at issue; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Annual Report on Form 10-K filed with the Securities and Exchange Commission February 26, 2016, and its other reports, which are available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investors.” All forward looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
VP, Corporate Communications and Business Development
SOURCE Orexigen Therapeutics, Inc.
Results of Vepoloxamer Nonclinical Studies in Advanced Heart Failure Presented at European Society of Cardiology 3rd World Congress on Acute Heart Failure
– Ex vivo study results indicate that by limiting unregulated calcium entry, vepoloxamer improves calcium cycling and left ventricle (LV) function in dogs with severe heart failure
SAN DIEGO, May 23, 2016 /PRNewswire/ — Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, today announced that data from nonclinical studies of vepoloxamer, its lead product candidate, were presented at the European Society of Cardiology 3rd World Congress on Acute Heart Failure by Dr. Hani N. Sabbah, Professor of Medicine and Director of Cardiovascular Research at Henry Ford Health System, at 9:30 a.m. CEST on May 21, 2016. The conference is being held in Florence, Italy May 21 through May 24, 2016.
The studies evaluated the effects of vepoloxamer on ventricular function and calcium cycling proteins in dogs with severe heart failure. Animals were randomized to receive vepoloxamer or placebo (saline) and each received two infusions of vepoloxamer or saline control administered three weeks apart. Tissue samples obtained three weeks after the second infusion were assessed for Ca2+-ATPase activity, phosphorylated (p) phospholamban at serine-16 (p-PLB-s16), p-ryanodine receptors at serine-2808 (p-RYR-s2808) and p-sodium-calcium-exchanger 1 (p-NCX-1) measured using specific antibodies and Western blotting. LV tissue from seven normal animals was utilized for comparison. LV function was assessed by full hemodynamics, plasma n-terminal-pro brain natriuretic peptide (NT-proBNP) and plasma- troponin-I (Tn-I) at baseline and at 1, 2 and 3 weeks following each infusion.
With regard to calcium cycling proteins, saline infusions had no effect on any of the examined functional measures. However, as previously reported, treatment with vepoloxamer partially normalized activity and protein levels. The results suggest that by limiting unregulated calcium entry into the cell, vepoloxamer decreased calcium overload in failing cardiomyocytes and improved calcium cycling proteins, leading to improved LV function. With regard to ventricular function, vepoloxamer increased LV ejection fraction and progressively reduced NT-proBNP and Tn-I. These benefits were sustained for up to 3 weeks after the second infusion of vepoloxamer. The results suggest that therapy with repeat intravenous 2-hour infusions of vepoloxamer, pulsed at 3-week intervals, limits calcium overload, normalizes sarcoplasmic reticulum (SR) calcium cycling, improves LV systolic function, lowers NT-proBNP and reduces Tn-I, a measure of ongoing cardiomyocyte death.
Dr. Sabbah said: “Reducing calcium overload and normalization of key calcium cycling proteins along with improvements in LV systolic function are very promising findings and suggest significant potential to improve treatment for both acute and chronic heart failure patients.”
Dr. R. Martin Emanuele, the Company’s Senior Vice President, Development, said: “We believe the activity of vepoloxamer is very different from existing therapies and may offer a new approach to treating heart failure by directly improving heart function. Also, because of its unique mechanism, vepoloxamer should be additive to existing therapies. We look forward to further demonstrating vepoloxamer’s potential in our ongoing Phase 2 clinical trial in chronic heart failure patients.”
- Dr. Sabbah’s presentation, entitled “Vepoloxamer (purified poloxamer-188) improves LV function, limits cardiomyocyte calcium overload and restores integrity of calcium cycling proteins in myocardium of dogs with advanced heart failure,” was given during a rapid fire session at 9:30 a.m. CEST on May 21, 2016, in Florence, Italy.
- A copy of the presentation is now available on the Company’s website at: http://www.masttherapeutics.com/technology/publications/
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is developing two clinical-stage investigational new drugs for serious or life-threatening diseases and conditions. Vepoloxamer, the Company’s lead product candidate, is in Phase 3 clinical development for the treatment of vaso-occlusive crisis in patients with sickle cell disease and in Phase 2 clinical development for the treatment of patients with heart failure. Enrollment in the Company’s 388-patient Phase 3 study of vepoloxamer in patients with sickle cell disease, known as the EPIC study, was completed in February 2016. Enrollment in the Company’s Phase 2 study of vepoloxamer in patients with chronic heart failure is ongoing. AIR001, the Company’s second product candidate, is in Phase 2 clinical development for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). Enrollment in a Phase 2a study of AIR001 in patients with HFpEF is ongoing and AIR001 was recently selected by the Heart Failure Clinical Research Network for evaluation in a 100-patient, multicenter, randomized, double-blind, placebo-controlled, Phase 2 study in patients with HFpEF. More information can be found on the Company’s web site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the Company’s current expectations and assumptions. Such forward-looking statements may be identified by the use of forward-looking words such as “intend,” “plan,” “anticipate,” “believe,” “expect,” among others, and include, but are not limited to, statements relating to prospects for successful development of vepoloxamer as a treatment for heart failure patients. There are a number of factors that could cause or contribute to material differences between actual events or results and the expectations indicated by the forward-looking statements. These factors include, but are not limited to: the inherent uncertainty of outcomes in ongoing and future studies of the Company’s product candidates and the risk that its product candidates may not demonstrate adequate safety, efficacy or tolerability in one or more such studies, including in the ongoing Phase 2 study of vepoloxamer in patients with chronic heart failure; delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a “clinical hold,” and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; delays in clinical study closeouts, including blinded data review and quality control and assurance procedures; the risk that, even if current and planned clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company’s dependence on third parties to assist with important aspects of development of its product candidates, including conduct of its clinical studies and supply and manufacture of clinical trial material, and, if approved, commercial product, and the risk that such third parties may fail to perform as expected, leading to delays in product candidate development or approval or inability to meet market demand for approved products, if any; the risk that the Company may be required to repay its outstanding debt obligations on an accelerated basis and/or at a time that could be detrimental to its financial condition, operations and/or business strategy, including the prepayment of $10 million of the principal balance if results from the EPIC study are not positive; risks associated with the Company’s ability to manage operating expenses and/or obtain additional funding to support its operations on a timely basis or on acceptable terms, or at all; the potential for the Company to significantly delay, reduce or discontinue current and/or planned development and commercial-readiness activities or sell or license its assets at inopportune times if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success and may never achieve profitability; the risk that the Company is not able to obtain and maintain effective patent coverage or other market exclusivity protections for its products, if approved, without infringing the proprietary rights of others; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
SOURCE Mast Therapeutics, Inc.
SAN DIEGO, May 23, 2016 /PRNewswire/ — GenomeDx Biosciences today announced that four presentations featuring Decipher Genomics Resource Information Database (Decipher GRID®) and Decipher® Tests in Prostate Cancer will be presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting held June 3-7 in Chicago.
The abstract titled “Development and Validation of Genomic Signature that Predicts ADT Treatment Failure,” was chosen to be discussed at the Poster Discussion Session, and will be presented by R. Jeffrey Karnes, M.D., associate professor and vice chair in urology at Mayo Clinic, on Saturday, June 4 from 4:45 p.m. to 6:00 p.m. CDT.
Title: Development and Validation of Genomic Signature that Predicts ADT Treatment Failure
Date: Saturday, June 4, 2016
Poster Session: Hall A (1:00 p.m. to 4:30 p.m. CDT)
Discussion Session: Hall D1 (4:45 p.m. to 6:00 p.m. CDT)
Abstract Number: 5018
Poster Number: 275
Presenter: R. Jeffrey Karnes, M.D., Mayo Clinic
Title: Effect of a Genomic Classifier on Adjuvant Treatment Decision-Making Among Patients with High-Risk Pathology at Radical Prostatectomy: Results from the Multicenter Prospective PRO-IMPACT Study
Date: Saturday, June 4, 2016
Poster Session: Hall A (1:00 p.m. to 4:30 p.m. CDT)
Abstract Number: e16558
Poster Number: 310
Presenter: John L. Gore, M.D., M.S., University of Washington School of Medicine
Title: Deciphering the Genomic Fingerprint of Small Cell Prostate Cancer with Potential Clinical Utility in Radical Prostatectomy Tissues
Date: Saturday, June 4, 2016
Poster Session: Hall A (1:00 p.m. to 4:30 p.m. CDT)
Abstract Number: 5055
Poster Number: 312
Presenter: Elai Davicioni, Ph.D., GenomeDx Biosciences
Title: Validation of a Genomic Risk Classifier to Predict Prostate Cancer-Specific Mortality (PCSM) in High-Risk Patients
Date: Saturday, June 4, 2016
Poster Session: Hall A (1:00 p.m. to 4:30 p.m. CDT)
Abstract Number: 5056
Poster Number: 313
Presenter: R. Jeffrey Karnes, M.D., Mayo Clinic
About Decipher® Prostate Cancer Classifier Tests
Our Decipher prostate cancer classifier tests are currently comprised of Decipher Biopsy and Decipher Post-Op. These commercially available genomic tests provide an assessment of tumor aggressiveness based on the patient’s unique genomic profile. Decipher Biopsy is indicated for men after biopsy diagnosis and Decipher Post-Op is indicated for men after prostate removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups to better determine which patients will likely benefit from additional treatment and which will not, thereby enabling improved decision-making and helping low-risk patients avoid unnecessary treatments that have serious adverse side effects and result in unnecessary costs to the healthcare system. Studies of thousands of patients from leading cancer centers, published in multiple peer-reviewed journals, demonstrate that the Decipher tests can more accurately predict disease aggressiveness than traditional clinical measures, such as PSA and Gleason score. Decipher Post-Op is covered by Medicare and by a number of private payors and preferred provider organizations representing, together with Medicare, about 70% of the approximately 66 million adult men in the United States age 40 or older who are at increased risk of being diagnosed with prostate cancer.
Learn more at www.DecipherTest.com
About Decipher GRID®
Our Decipher Genomics Resource Information Database (Decipher GRID) is a genomic expression database that provides a foundation for open and interactive research collaboration and knowledge creation. Decipher GRID is a rapidly growing database that contains genomic profiles of thousands of patient tumors, and constitutes what we believe to be the world’s largest shared, clinically-annotated genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases utilizing cloud-based analytics. We believe Decipher GRID gives rise to new opportunities for information technology-enabled genomic solutions and enables us to more rapidly discover, develop, commercialize and drive the adoption of our existing and new genomic tests. Through Decipher GRID, GenomeDx is building a suite of genomic tests in urologic cancer that we believe will allow us to achieve our goals of reducing costs to the healthcare system and improving patient lives, from screening through late-stage therapy.
Learn more at www.DecipherGRID.com
About GenomeDx Biosciences
GenomeDx Biosciences uses the power of collaborative genomics to transform the management and treatment of cancer patients. GenomeDx has built Decipher GRID, a large genomics database in urologic cancer that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID to analyze vast amounts of genomic data, GenomeDx develops and commercializes proprietary clinical tests that are intended to provide more accurate and useful diagnostic information than both traditional diagnostic tools and existing genomic tests. GenomeDx’s Decipher Biopsy and Decipher Post-Op are commercially available prostate cancer genomic tests that provide an assessment of tumor aggressiveness based on a patient’s unique genomic profile. GenomeDx is headquartered in Vancouver, British Columbia and has offices in San Diego, California.
Learn more at www.GenomeDx.com
SOURCE GenomeDx Biosciences Inc.
Continues to execute on 2016 Company priority with second pharma company agreement
SAN DIEGO, May 23, 2016 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading molecular diagnostics company with liquid biopsy technology for cancer profiling and monitoring, announces that it has entered into a master services agreement with a biopharmaceutical company to develop targeted liquid biopsy tests for multiple tumor types and molecular targets. The agreement includes utilizing Biocept’s patented, proprietary Target Selector™ platforms to develop assays with both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA).
Following the successful completion of the first phase of the agreement, Biocept has qualified for an expanded pipeline of projects with associated milestone payments that could reach $500,000 or more based on the development of multiple assays. Additional terms of the contract were not disclosed.
“As we accumulate more data demonstrating the validity of our dual CTC and ctDNA Target Selector platforms, more pharmaceutical companies are taking notice,” said Lyle Arnold, PhD, Biocept’s Senior Vice President and Chief Scientific Officer. “We earned this project based on the flexible and robust capabilities of our technology to develop tests for multiple tumor types.”
“We are executing on a stated objective for 2016 of increasing the utilization of our tests in clinical trials and this agreement is our second with a major pharmaceutical company this year,” said Michael W. Nall, President and CEO of Biocept. “We see a significant opportunity for pharma companies to employ our liquid biopsy tests to profile specific biomarkers in their oncology drug development activities. Pharmaceutical master services agreements can take months or years to develop and labs must perform the testing on time, within under high-quality control standards. We have already shown our ability to perform and are pleased to enter into this multi-project contract as we further expand into this important aspect of our business.”
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers and melanoma. The company uses its proprietary liquid biopsy technology to provide physicians with more precise information for treating and monitoring patients with cancer. The company’s patented Target Selector™ liquid biopsy technology platform captures and analyzes circulating tumor material in both CTCs and in ctDNA. The platform has proven to be effective in identifying cancer mutations. Biocept plans to introduce additional CLIA-validated tests in the near term. For additional information, please visit www.biocept.com.
Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the detection and treatment of cancer, our impact on diagnostic strategies, the amount of work we will perform and the amount of revenue we will generate under the development project, our ability to increase our share of the pharmaceutical clinical trial market and planned future offerings, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.
SOURCE Biocept, Inc.
SAN DIEGO, May 23, 2016 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that it has entered into a definitive agreement with a single healthcare dedicated institutional fund to purchase approximately $10 million of securities in an at-the-market registered direct offering. OncoSec has agreed to sell to such investors an aggregate of 5,509,642 shares of its common stock, or pre-funded warrants in lieu thereof, at a price of $1.815 per share. Additionally, investors will receive warrants to purchase up to an aggregate of 5,509,462 shares of common stock at an exercise price of $1.69 per share for a term of 9 years. The warrants are immediately exercisable on the date of issuance.
The gross proceeds of the offering are $10 million. Net proceeds, after deducting the placement agent’s fee, financial advisory fees, and other estimated offering expenses payable by OncoSec, are expected to be approximately $9.1 million. OncoSec intends to use proceeds from the offering for general corporate purposes, including clinical trial expenses and research and development expenses.
Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, acted as the exclusive placement agent in connection with this offering. The offering is expected to close on or about May 26, 2016, subject to the satisfaction of customary closing conditions.
The securities described above are being offered by OncoSec pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission, or the SEC. A prospectus supplement related to the offering will be filed with the SEC. The securities may only be offered by means of a prospectus. Copies of the prospectus and prospectus supplement can be obtained directly from OncoSec and at the SEC’s website at www.sec.gov or by request from H.C. Wainwright & Co., LLC by e-mailing firstname.lastname@example.org.
This announcement is neither an offer to sell nor a solicitation of an offer to buy any of OncoSec’s common stock or warrants. No offer, solicitation, or sale will be made in any jurisdiction in which such offer, solicitation, or sale is unlawful.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse™, for the treatment of cancer. ImmunoPulse™ is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse™ IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse™ IL-12, is currently in clinical development for several indications, including metastatic melanoma and triple-negative breast cancer. In addition to ImmunoPulse™ IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “expect,” “will,” “intend,” and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec’s filings with the Securities and Exchange Commission.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
OncoSec Medical Incorporated
SOURCE OncoSec Medical Incorporated
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