Cantex Pharmaceuticals, Inc. Receives FDA Fast Track Designation For CX-01 For The Treatment Of Patients Over Age 60 With Newly Diagnosed Acute Myeloid Leukemia (AML)

On August 27, 2018 Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancer, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation for Cantex’s lead product candidate, CX-01, for the treatment of patients over age 60 receiving induction therapy for newly diagnosed acute myeloid leukemia ("AML") (Press release, Cantex, AUG 27, 2018, View Source [SID1234529084]). Earlier this year, the FDA had also granted Orphan Drug Designation to CX-01 for the treatment of AML.

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Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track Designation is afforded greater access to FDA for the purpose of expediting the drug’s development, review and potential approval.

CX-01 is currently in clinical development for newly diagnosed AML, and refractory myelodysplastic syndrome ("MDS"). CX-01 is designed to block the activity of chemokines that support the resistance of blood cancers to treatment and that contribute to the delay of bone marrow recovery after chemotherapy. Among these chemokines are CXCR4 and CXCL12, which are critical to the attachment of blood cancer cells to the protective bone marrow environment, and platelet factor 4, which slows bone marrow recovery after chemotherapy.

Stephen Marcus, M.D., Chief Executive Officer of Cantex Pharmaceuticals, Inc., commented, "Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults, with approximately 19,500 new cases, more than 60% of which are in people over age 60, estimated in the United States for 2018. Over age 60, the response to initial ‘induction’ therapy is lower, the risk of relapse is higher, and the overall survival is generally shorter, creating a significant unmet medical need for improvement in the effectiveness of this induction therapy." Dr. Marcus added, "We believe that the award of Fast Track Designation represents recognition of CX-01’s potential to address a significant unmet need in the treatment of AML by enhancing the efficacy of front-line AML chemotherapy. We will work closely with major cancer treatment centers and with the FDA with the goal of bringing CX-01 to patients as quickly as possible."

About Fast Track Designation

Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions. A drug that qualifies for Fast Track Designation must demonstrate the potential to treat a serious condition for which there is an unmet medical need for improved treatment.

About Orphan Drug Designation

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides important incentives, including seven-year marketing exclusivity upon FDA approval, tax credits for qualified clinical testing, and prescription drug user fee exemption.

CytRx Corporation to Present at the H.C. Wainwright & Co. 20th Annual Global Investment Conference in New York City September 4-6, 2018

On August 27, 2018 CytRx Corporation (Nasdaq : CYTR ), a biopharmaceutical research and development company specializing in oncology, reported that Mr. Eric Curtis, President and Chief Operating Officer, will present at the H.C. Wainwright 20th Annual Global Investment Conference (Press release, CytRx, AUG 27, 2018, View Source;co-20th-annual-global-investment-conference-in-new-york-city-september-4-6-2018-300702289.html [SID1234529083]). The presentation will occur on Wednesday, September 5 at 11:40 A.M. Eastern Daylight Time at the St. Regis Hotel in New York City.

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A live and archived webcast of the presentation will be available at View Source

Lilly to Participate in Morgan Stanley Global Healthcare Conference

On August 27, 2018 Eli Lilly and Company (NYSE : LLY ) reported that it will attend the Morgan Stanley Global Healthcare Conference on Wednesday, September 12, 2018. Joshua Smiley, senior vice president and Lilly’s chief financial officer, will participate in a fireside chat at 1:40 p.m., Eastern Time (Press release, Eli Lilly, AUG 27, 2018, View Source [SID1234529082]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

CStone’s Anti-CTLA-4 Antibody CS1002 Receives IND Approval in China

On August 27, 2018 CStone Pharmaceuticals (CStone) reported that its IND application for CS1002, an investigational cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, has been approved by the China National Drug Administration (CNDA) (Press release, CStone Pharmaceauticals, AUG 27, 2018, View Source [SID1234529081]).

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"We are very pleased to obtain our third China IND approval of our investigational drugs in 2018. CStone already initiated CS1002’s Phase I clinical trial in Australia and dosed the first patient in May." said Dr. Frank Jiang, Chairman and Chief Executive Officer of CStone. " With today’s IND approval of CS1002, CStone is currently the only biopharmaceutical company in China that has all three immuno-oncology ‘backbone’ products (anti-PD-L1, anti-PD-1, and anti-CTLA-4 mAbs) in the clinical stage."

"CS1002 has demonstrated a high level of selectivity, specificity and high affinity to CTLA-4 in preclinical studies," said Dr. Jingrong Li, Senior Vice President of Product Development and Manufacture at CStone. "Combination therapies of anti-CTLA-4 mAb with anti-PD-1 mAb have demonstrated promising efficacy in multiple tumor types by global clinical trials. CStone will explore combination potentials between CS1002 and other drug candidates in our pipeline to provide better therapies for cancer patients in China and beyond."

As of today, CStone has built a portfolio of 14 oncology products, 8 of which are at clinical development stage, including 3 in registration studies. CS1001, China’s first fully human, full-length anti-PD-L1 mAb developed by CStone, has entered pivotal Phase II clinical studies, and will potentially become one of the first locally-developed anti-PD-L1 cancer drugs launched in China. In June 2018, CStone announced the exclusive collaboration and license agreements with Blueprint Medicine and Agios Pharmaceuticals. With these two deals, CStone in-licensed 4 post proof of concept assets, including ivosidenib, which is recently approved by U.S. FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, and avapritinib, which has entered global Phase III clinical studies.

About the CTLA-4 pathway

Cytotoxic T lymphocyte associated antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene that can down-regulate the activity of T cells when binding with its ligands, B7.1 and B7.2, a pathway also used by tumor cells to avoid T lymphocyte attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell activation and proliferation to induce or enhance anti-tumor immune responses. CTLA-4 provides a new immuno-therapeutic approach to a number of diseases, including tumors.

Presently, Bristol-Myers Squibb’s Yervoy (ipilimumab) is the only anti-CTLA-4 antibody to gain a market approval worldwide, although Yervoy has not yet been approved in China. Pre-clinical tests have shown that CS1002 has a relatively strong affinity to CTLA-4 and is expected to match Yervoy in terms of efficacy.

DURECT to Present at the 20th Annual Rodman & Renshaw Global Investment Conference

On August 27, 2018 DURECT Corporation (Nasdaq: DRRX) announced today that James E. Brown, President and CEO, will be presenting at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., on Thursday, September 6 at 9:10 a.m. Eastern Time (Press release, DURECT, AUG 27, 2018, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2364967 [SID1234529080]). The conference is being held at the St. Regis Hotel in New York City. Institutional investors and analysts that are attending the conference may request a one-on-one meeting through the conference coordinators.

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A live audio webcast of the presentation will be available by accessing View Source

A live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section