On February 14, 2018 Oncoceutics Inc. and Calvert Research, LLC reported that the two companies have entered into a second product development and investment partnership agreement, this time to further develop and enable the submission of an investigational new drug (IND) application for ONC206, Oncoceutics’ next generation molecule (Press release, Oncoceutics, FEB 14, 2018, View Source [SID1234558372]).

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As a part of this second agreement, Calvert Research will enlist the capabilities of its CRO affiliate, Calvert Laboratories, Inc. to conduct certain GLP animal safety and pharmacology studies on ONC206 in its GLP certified facilities. In addition, Calvert Research has made a second equity investment in Oncoceutics. This agreement follows the same successful investment-development partnership model established between Oncoceutics and Calvert Research in 2013 that lead to Oncoceutics being able to open an IND application for ONC201, its lead molecule.

ONC206 is a member of a family of drug candidates called "imipridones" that possess the same core structure of ONC201 and that have demonstrated the same favorable drug characteristics, including efficacy in pre-clinical models against cancer with high levels of safety. Given these attractive attributes, Oncoceutics filed a pre-IND application with the FDA describing its plans for a clinical trial with ONC206 and received positive written feedback to the pre-IND submission from the FDA. Based on the FDA written response, Oncoceutics has defined all of the studies required to have an IND accepted by the FDA. These include manufacturing ONC206 in quantity and at quality sufficient to treat people, and the toxicology work necessary to open an investigational new drug application (IND) that will be completed by Calvert Laboratories. Oncoceutics expects to complete all studies by the end of 2018 and to file the IND and begin first-in-human studies for ONC206 in 2019.

Previously, Oncoceutics has announced that the United States Patent and Trademark Office (USPTO) has issued a patent providing the company with composition of matter protection for ONC206.

"We are pleased to enter into a second investment partnership agreement with Calvert Research, a firm that possesses excellent capabilities in the field of GLP-compliant animal safety studies," said Martin Stogniew Ph.D., Chief Development Officer of Oncoceutics. "By bringing the second member of the imipridone family towards a clinical trial, we are continuing our transformation of Oncoceutics from a company with one drug in development into a company developing a portfolio of drugs."

On February 14, 2018 The U.S. Food and Drug Administration reported the approval of Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant) (Press release, US FDA, FEB 14, 2018, View Source [SID1234523990]). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.

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"The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public."

According to the National Cancer Institute (NCI) at the National Institutes of Health, prostate cancer is the second most common form of cancer in men in the U.S.. The NCI estimates approximately 161,360 men were diagnosed with prostate cancer in 2017, and 26,730 were expected to die of the disease. Approximately 10 to 20 percent of prostate cancer cases are castration-resistant, and up to 16 percent of these patients show no evidence that the cancer has spread at the time of the castration-resistant diagnosis.

Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.

The safety and efficacy of Erleada was based on a randomized clinical trial of 1,207 patients with non-metastatic, castration-resistant prostate cancer. Patients in the trial either received Erleada or a placebo. All patients were also treated with hormone therapy, either with gonadotropin-releasing hormone (GnRH) analog therapy or with surgery to lower the amount of testosterone in their body (surgical castration). The median metastasis-free survival for patients taking Erleada was 40.5 months compared to 16.2 months for patients taking a placebo.

Common side effects of Erleada include fatigue, high blood pressure (hypertension), rash, diarrhea, nausea, weight loss, joint pain (arthralgia), falls, hot flush, decreased appetite, fractures and swelling in the limbs (peripheral edema).

Severe side effects of Erleada include falls, fractures and seizures.

This application was granted Priority Review, under which the FDA’s goal is to take action on an application within 6 months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program, an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page.

The FDA granted the approval of Erleada to Janssen Pharmaceutical Companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On February 14, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, February 21, 2018 to report its fourth quarter and full year 2017 financial results and provide a corporate update (Press release, Blueprint Medicines, FEB 14, 2018, View Source;p=RssLanding&cat=news&id=2332382 [SID1234523965]).

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To access the live conference call, please dial 1-855-728-4793 (domestic) or 1-503-343-6666 (international), and refer to conference ID 3391675. A live webcast will be available under "Events and Presentations" in the Investors section of Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On February 14, 2018 NanOlogy, a clinical-stage pharmaceutical development company and affiliate of DFB Pharmaceuticals, reported the first patient in a Phase 1/2 clinical trial of a submicron particle paclitaxel topical anhydrous ointment for the treatment of cutaneous metastases (Press release, NanOlogy, FEB 14, 2018, View Source [SID1234523975]). The open label dose escalating trial of three different strengths of the product will be followed by dose confirmation to evaluate safety. NanOlogy has licensed the topical formulation for use in oncology from DFB Soria, which is owned and operated by DFB.

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Because no other topical treatment options exist for many patients suffering from cutaneous metastases, the company says it will seek to gain FDA fast track status if the results of this trial are successful.

Separately, Soria has completed enrollment in a Phase 2 actinic keratosis clinical trial that is evaluating different strengths of the topical formulation for safety and efficacy. Results from the randomized, double-blind, placebo-controlled trial are expected in April; preliminary blinded observations are promising.

On February 13, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP), reported that management will host a conference call and webcast slide presentation on Thursday, March 1, at 4:30 p.m. ET to provide a corporate update and discuss financial results for the fourth quarter and year ended Dec. 31, 2017 (Press release, Ziopharm, FEB 13, 2018, View Source [SID1234523991]).

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The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 3782628. To access the slides and live webcast or the subsequent archived recording, visit the "Investors & Media" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.