On July 21, 2015 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the pricing of its previously announced underwritten public offering (Press release, CytRx, JUL 21, 2015, View Source;p=RssLanding&cat=news&id=2069484 [SID:1234506553]).

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CytRx is offering 9,100,000 shares of common stock at a public offering price of $2.75 per share for gross proceeds of approximately $25.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by CytRx.

CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and its drug discovery activities and for general corporate purposes, which may include pre-commercialization activities relating to aldoxorubicin, working capital, capital expenditures, research and development and other commercial expenditures. CytRx has granted the underwriters a 30-day option to purchase up to an additional 1,365,000 shares of common stock. The offering is expected to close on or about July 24, 2015, subject to the satisfaction of customary closing conditions.

Jefferies LLC is the sole book-running manager for the offering. Oppenheimer & Co. Inc., Aegis Capital Corp., FBR Capital Markets & Co., and H.C. Wainwright & Co., LLC are acting as co-lead managers for the offering.

CytRx is offering the shares described above pursuant to a shelf registration statement on Form S-3, including a base prospectus, which was previously filed with and has been declared effective by the Securities and Exchange Commission (SEC). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement related to the offering was filed with the SEC on July 20, 2015 and a final prospectus supplement related to the offering will be filed with the SEC today. Copies of the final prospectus supplement and the accompanying prospectus, when available, may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by email at [email protected] or by phone at 877-547-6340 or by accessing the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of CytRx Corporation, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 20, 2015 Dr. Jack Kavanaugh, Chairman of Novonco Pharmaceuticals, Inc., reported that Novonco has licensed the exclusive rights to City of Hope’s novel anti-cancer agent COH29, a potential breakthrough agent in the fight against hard-to-treat cancers, including ovarian cancer (Press release, Novonco Therapeutics, JUL 20, 2015, View Source [SID1234645698]).

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The small molecule COH29 inhibits the production of ribonucleotide reductase (RNR), an enzyme that is central to production of many types of cancer cells. Current clinically-established RNR inhibitors — such as hydroxyurea and gemcitabine — have drawbacks, including a short half-life and drug resistance. But COH29 represents a new class of RNR inhibitors, with unique targeted-action mechanisms that limit damage to non-cancer cells, thus limiting side effects. Preclinical trials suggest it can overcome hydroxyurea and gemcitabine resistance in cancer cells and may serve as a first- or second-line treatment in relevant cancers. This novel therapeutic agent has been in development at City of Hope’s Beckman Research Institute.

In preclinical studies, COH29 has been shown to reduce tumor growth in human cancers, including leukemia and ovarian cancer — diseases that are hard to treat, and it has also shown promise against breast cancer cells. "One of the real potentials of COH29," says Dr. David Horne, co-chairman of Novonco’s Medical Advisory Board, "is its potent antitumor activity against BRCA1-deficient ovarian cancer."

Ovarian cancer (OC) is the most lethal — and the second most-common — gynecologic cancer in the United States, with over 20,000 new cases and 14,000 deaths expected yearly. Most of the cases are diagnosed at an advanced stage, with a corresponding 5-year survival rate of only 27 percent. Today, primary treatment of OC typically consists of surgery followed by first-line chemotherapy with a platinum/taxol combination. First-in-human Phase I clinical trials of COH29 are scheduled to begin in the fall of 2015 at City of Hope.

"We at Novonco are excited to work with City of Hope on COH29, which holds so much promise for the treatment of ovarian and other hard-to-treat cancers," says Dr. Kavanaugh. The company is working on two other cancer therapeutic platforms, based on individual licensing arrangements with City of Hope and the University of California Irvine.

In 2009, in conjunction with City of Hope, Dr. Kavanaugh founded ZetaRx Therapeutics. Dr. Kavanaugh was also the Chairman and CEO of ZetaRx, which became the core of Juno Therapeutics. Juno was the largest biotech IPO of 2014 and attained a market cap of approximately $6 billion.

On July 20, 2015 National Cancer Institute reported that Interim results from a randomized controlled phase II trial show that pembrolizumab (Keytruda) improves progression-free survival in patients with melanoma that has gotten worse during treatment with ipilimumab (Yervoy), and with a BRAF or MEK inhibitor (if the tumor carried the BRAF V600 mutation), compared with chemotherapy (Press release, , JUL 20, 2015, View Source [SID:1234506700]).

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The findings were published online in The Lancet Oncology on June 24. Antoni Ribas, M.D., Ph.D., of the University of California, Los Angeles, was the first author of the study, which was sponsored by Merck Sharp & Dohme, the maker of pembrolizumab.

Pembrolizumab is a targeted therapy known as an immune checkpoint inhibitor. The drug, a monoclonal antibody, binds to a protein on T cells called PD-1. When PD-1 is activated by binding to a protein that is produced by many tumor cells, the immune response is suppressed. Binding of pembrolizumab to PD-1 blocks activation of the PD-1 pathway, allowing the immune response to proceed.

In September 2014, the Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab as a second-line therapy for advanced melanoma that has progressed (gotten worse) during treatment with ipilimumab or BRAF inhibitors. The approval was based on results from a randomized phase IB trial, called KEYNOTE-001. As a condition of this accelerated approval, Merck was required to conduct a multicenter randomized trial to establish the superiority of pembrolizumab over standard therapy and to describe its clinical benefit.

In the current trial, called KEYNOTE-002, 540 patients with advanced melanoma were randomly assigned to receive one of three treatment regimens: pembrolizumab at a dose of 2 milligrams per kilogram of body weight every 3 weeks, pembrolizumab at a dose of 10 milligrams per kilogram of body weight every 3 weeks, or chemotherapy selected by the patient’s physician. Neither the patients nor the investigators knew which dose of pembrolizumab individual patients received, although they knew whether the treatment was pembrolizumab or chemotherapy.

Overall survival will be the primary endpoint at the final analysis. At this interim analysis, the primary endpoint was progression-free survival, and the secondary endpoints included safety.

The 6-month progression-free survival rates were 34 percent for patients who received the lower dose of pembrolizumab, 38 percent for patients who received the higher dose of pembrolizumab, and 16 percent for patients who received chemotherapy.

Patients in the pembrolizumab groups had lower incidences of treatment-related grade 3-4 adverse events than patients in the chemotherapy group. Such side effects were seen in 20 patients who received the lower dose of pembrolizumab (11 percent), 25 patients who received the higher dose of pembrolizumab (14 percent), and 45 patients who received chemotherapy (26 percent).

The most common treatment-related grade 3-4 adverse events in the lower-dose pembrolizumab group were fatigue, edema, and myalgia. In the higher-dose pembrolizumab group, the most common treatment-related grade 3-4 adverse events included colitis, decreased appetite, and diarrhea. And for the chemotherapy group, the most common grade 3-4 treatment-related adverse events included anemia, fatigue, and neutropenia.

Study participants were surveyed about their health-related quality of life (HRQoL). Overall, patients in the pembrolizumab groups scored better on HRQoL measures than patients in the chemotherapy group. "The inclusion of HRQoL data is a real strength and reflects the favorable tolerability of pembrolizumab, particularly in a group of patients with poor prognosis and who have been heavily pretreated," wrote the authors of an accompanying editorial.

Although more data are needed to assess overall survival, the current results suggest that the two doses of pembrolizumab are associated with similar outcomes, the study authors noted.

"These findings corroborate published results as well as the FDA’s decision to grant accelerated approval to pembrolizumab," said Howard Streicher, M.D., of NCI’s Cancer Therapy Evaluation Program, who was not involved in the trial. "The study clearly demonstrates the improvement of progression-free survival at either dose of pembrolizumab across every group in the study without regard to age or the number of prior treatments."

Based on the published studies to date, Dr. Streicher added, the emerging standard of care for the initial treatment of metastatic melanoma will involve giving sequences and combinations of the BRAF/MEK inhibitors and PD1/PDL1/CTLA4 monoclonal antibodies, such as ipilimumab, pembrolizumab, and nivolumab (Opdivo).

On July 20, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, reported that the Sarah Cannon Cancer Research Center at HealthOne, Denver, CO has been added as a clinical trial site for the ongoing, multicenter Phase I/II study of VAL-083 in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer (Press release, DelMar Pharmaceuticals, JUL 20, 2015, View Source [SID:1234506538]).

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"This fifth clinical site greatly adds to our recruitment bandwidth as part of our strategy to increase patient access as we continue with the expansion phase of our Phase I/II GBM clinical trial. Our goal is to complete the expansion phase and advance VAL-083 into registration-directed Phase II/III clinical trials for refractory glioblastoma in the timeliest manner possible," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.

Sarah Cannon Research Institute (SCRI) is the research arm of HCA’s global cancer enterprise, Sarah Cannon. SCRI’s Denver site is directed by Gerald Falchook, M.D., M.S. Dr. Falchook completed his oncology training at MD Anderson Cancer Center, where he also served as a faculty member for six years developing investigator-initiated clinical trials as well as collaborating with pharma/biotech industry partners to bring promising new drugs to cancer patients.

"Expanding our collaboration with SCRI provides access to leading oncologists to support the development of VAL-083 as a novel cancer chemotherapy and will enable more rapid patient enrollment to our GBM clinical trial by accessing SCRI’s large network of patients," added Mr. Bacha.

DelMar’s multicenter Phase I/II study with VAL-083 is ongoing in patients with recurrent GBM. The clinical trial is an open-label, single arm, safety and tolerability dose-escalation study utilizing a standard dose escalation design, until the maximum tolerated dose (MTD) or the maximum specified dose has been reached. Eligible GBM inclusion criteria requires previous treatment with surgery and/or radiation, if appropriate. Eligible GBM patients must have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).

Recently DelMar presented interim data from this ongoing study in GBM at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar is also enrolling patients in the trial at four other oncology centers of excellence: The Mayo Clinic Cancer Center in Rochester, MN, The Brain Tumor Center at University of California, San Francisco (UCSF),.; The Sarah Cannon Cancer Research Center in Nashville, TN.; The Sarah Cannon Research Institute affiliate site at the Florida Cancer Specialist Research Institute in Sarasota, FL.; and. More information on the VAL-083 Phase I/II clinical trial in GBM may be found at View Source

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).