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OPKO Announces 4Kscore® Abstracts at the 2015 American Urological Association (AUA) Annual Meeting

On May 18, 2015 OPKO Health, Inc. (NYSE:OPK) reported six important new clinical trial results pertaining to the 4Kscore test presented at the 2015 American Urological Association (AUA) annual meeting, May 15 to May 19, 2015, in New Orleans (Press release, Opko Health, MAY 18, 2015, View Source [SID:1234506562]).

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Date and time, title and location of the 4Kscore presentations at the New Orleans Morial Convention Center (NOMCC):

Friday, May 15, 1:00 pm – Moderated poster MP6-04: The 4Kscore Test predicts high-grade prostate cancer on biopsy with PSA less than 4 ng/mL; NOMCC #220-221

Sunday May 17, 11:10 am – Urologic Oncology Forum podium presentation: Screening for lethal prostate cancer using PSA and related blood biomarkers; NOMCC #356-357

Sunday May 17, 12:50 am – Urologic Oncology Forum podium presentation: Use of commercial blood biomarkers to identify risk of aggressive prostate cancer; NOMCC #356-357

Monday, May 18, 8:00 am – Moderated poster MP60-06: The performance of the 4Kscore for predicting high-grade cancer on biopsy of the prostate does not depend on the age of the patient; NOMCC #206-207

Monday May 18, 10:30 am – Podium presentation PD38-03: The 4Kscore is associated with more advanced disease at radical prostatectomy; Results from a multi-Institutional prospective trial; NOMCC #215-216

Tuesday, May 19, 8:00 am – Moderated poster MP77-20: Among men with low-grade prostate cancer on prostate biopsy, the 4Kscore predicts more aggressive prostate cancer at prostatectomy; NOMCC 228-230

In addition to the regular AUA program presentations, the OPKO 4Kscore test will also be featured on Tuesday May 19th in an industry program titled "Biomarkers and Genomic Testing in Prostate Cancer: Integration Into Clinical Practice" from 10:00 – 11:00 am at NOMCC Science and Technology Hall #1043

About the 4Kscore Test

The 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2). These biomarkers are combined with a patient’s age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between a Urologist and patient.

R&D alliance restructure presents new DNA damage response partnership opportunities including leading PolQ project

On May 18, 2015 Cancer Research Technology (CRT) reported that Teva Pharmaceutical Industries Ltd has returned a portfolio of DNA Damage Response (DDR) projects to CRT (Press release, Cancer Research Technology, MAY 18, 2015, View Source [SID1234523205]). The move, which follows a strategic decision by Teva to focus on market-ready or close-to-market assets in oncology, presents new partnership opportunities including a leading PolQ project.

The alliance, which bought together world-leading Cancer Research UK scientists in the field of DDR research, CRT’s drug discovery team (CRT’s Discovery Laboratories) and Teva, has successfully established an early DDR portfolio that will continue to be developed by CRT’s Discovery Laboratories whilst a new partner is sought.

The portfolio includes a drug discovery programme targeting PolQ. PolQ is implicated in a wide range of roles including double strand break repair. It is anticipated that Inhibitors of PolQ will induce radiosensitisation in a range of cancers, and potentially exhibit stand alone activity in Homologous Recombination (HR) deficient tumours**.

The DNA damage response pathways can activate cell cycle checkpoints to stop cells dividing, or they can activate specific DNA repair pathways in response to certain types of DNA damage. Some of the proteins in these pathways are mutated, or non-functional in human tumours. This can cause cancer cells to be more reliant on an intact DNA repair pathway for survival providing a therapeutic window. Developing new drugs that target DDR is a promising new avenue of research to tackle this problem.

Dr Phil L’Huillier, said: "Together with Teva, CRT has created an exciting portfolio, backed by a world-class hub of expertise in DDR-related basic, translational, and clinical research, that we will continue to develop through our in-house drug discovery laboratories.

"This restructure represents a unique new partnership opportunity to research and develop first-in-class cancer drugs that exploit DNA damage and repair response processes to fight cancer."

. The move, which follows a strategic decision by Teva to focus on market-ready or close-to-market assets in oncology, presents new partnership opportunities including a leading PolQ project.

"This restructure represents a unique new partnership opportunity to research and develop first-in-class cancer drugs that exploit DNA damage and repair response processes to fight cancer."

Agios Announces FDA Fast Track Designation Granted to AG-120 for Treatment of Patients with Acute Myelogenous Leukemia with an IDH1 Mutation

On May 18, 2015 Agios Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation (Press release, Agios Pharmaceuticals, MAY 18, 2015, View Source [SID1234504501]).

AG-120 is a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein being evaluated in two Phase 1 clinical trials, one in hematologic malignancies that recently initiated three expansion cohorts, and one in advanced solid tumors, including glioma.

"We are pleased that now both AG-120 and AG-221 have been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our lead IDH programs as important new therapies for people with AML who carry these mutations," said Chris Bowden, M.D., chief medical officer of Agios. "We look forward to presenting new data from the ongoing Phase 1 study at the EHA (Free EHA Whitepaper) Annual Congress next month and remain on track to initiate a global, registration-enabling Phase 3 study in collaboration with Celgene in AML patients who harbor an IDH1 mutation in the first half of 2016."

The FDA’s Fast Track Drug Development Program is designed to expedite clinical development and submission of New Drug Applications (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available.

10-Q – Quarterly report [Sections 13 or 15(d)]

Vaccinogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Vaccinogen, MAY 15, 2015, View Source [SID1234504463]).

10-Q – Quarterly report [Sections 13 or 15(d)]

TapImmune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, TapImmune, MAY 15, 2015, View Source [SID1234504460]).