On July 11, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck’s Temodar (Press release, Mylan, JUL 11, 2016, View Source [SID:1234513811]). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

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Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, had U.S. sales of approximately $176.5 million for the 12 months ending May 31, 2016, according to IMS Health.

Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

On July 11, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), in collaboration with researchers from the Institute of Cancer Research in London, reported positive results for EndoPredict, a second-generation prognostic gene expression test for breast cancer (Press release, Myriad Genetics, JUL 11, 2016, View Source [SID:1234513812]). The study achieved its primary endpoint by demonstrating that EndoPredict (EPclin) was superior to the first-generation Oncotype DX Breast Recurrence Score (RS) in predicting the long-term recurrence of ER+, HER2- primary breast cancer. The study was published in the Journal of the National Cancer Institute (JNCI).

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"This important study demonstrated that EndoPredict more accurately predicted the recurrence of breast cancer up to 10 years after diagnosis in patients with ER+, HER2- breast cancer than the other test studied," said Jack Cuzick, Ph.D., FRS, director of the Wolfson Institute of Preventive Medicine in London, and an investigator of the study. "These findings will help physicians identify patients who do not need adjuvant chemotherapy following surgery, resulting in a more personalized treatment for their patients."

The analysis included 928 women from the TransATAC study and compared the prognostic power of EndoPredict versus the first-generation test. The primary endpoint of the study was distant relapse-free survival. This analysis showed that EndoPredict markedly outperformed Oncotype DX across the 10-year follow-up period with prognostic power more than four times higher (EPclin: LRX2= 139.3; RS: LRX2=29.1). Using pre-defined cutoffs, EndoPredict and Oncotype DX identified 58.8 percent and 61.7 percent of patients as low risk with hazard ratios for low- versus non-low-risk of 5.9 and 2.7, respectively. Importantly, the authors noted that "EPclin’s superior ability to classify patients as low risk was further demonstrated by the similar number of patients classified as low risk by RS coupled with a substantially lower 10-year recurrence rate (5.8% for EPclin vs 10.1% for RS)."

"EndoPredict significantly outperformed the first-generation prognostic test in this head-to-head study, especially for late distant recurrences and in node-positive patients" said Ralf Kronenwett, M.D., chief scientific and medical officer, Sividon. "Additionally, EndoPredict did not classify any patients as intermediate risk, while Oncotype DX classified 28 percent of as intermediate risk which can be confusing for clinicians trying to make treatment decisions."

The JNCI publication can be accessed at: View Source

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About EndoPredict
EndoPredict is a next-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety.

On July 11, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported that it has been granted a new European patent covering its investigational Phase 3 cancer immunotherapy drug Multikine* (Leucocyte Interleukin) (Press release, Cel-Sci, JUL 11, 2016, View Source [SID:1234513827]). The patent, EU Patent: EP 1 773 368 B1, titled "A Method Of Pre-Sensitizing Cancer Prior To Treatment With Radiation and/or Chemotherapy And A Novel Cytokine Mixture," is not limited to any one particular type of cancer and can include multiple types of cancer.

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This invention relates to a novel method for pre-sensitizing cancer cells prior to a therapeutic treatment such as chemotherapy or radiation therapy. This effect is created by CEL-SCI’s immunotherapy drug Multikine which, as part of its mode of action, induces cancerous cells to enter a proliferative cell cycle phase therapy, thereby potentially increasing their vulnerability to chemotherapy and radiation therapy.

Geert Kersten, Chief Executive Officer of CEL-SCI, said, "This European patent should protect one of the largest applications for Multikine, namely its use in combination with radiation and chemotherapy. Our ongoing Phase 3 clinical trial in head and neck cancer patients is administering Multikine therapy as part of a first-line treatment, before any other treatments and prior to surgery, followed by radiation or concurrent chemoradiotherapy."

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. The study is being conducted in 24 countries and has enrolled over 850 patients so far.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On July 11, 2016 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of cell therapies, reported an exclusive license agreement with the leading Japanese immuno-oncology company, ONO Pharmaceutical Co., Ltd. (TSE: 4528), for the development and commercialization of Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan (Press release, Celyad, JUL 11, 2016, View Source [SID1234516411]). This license agreement opens new markets to Celyad and expands the global footprint of its NKR-2 T-cell cancer immunotherapy treatment and potentially for other disease conditions.

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Celyad will receive an upfront payment of 1.25 JPY B (€11.25 million or $12.5 million) and is eligible of up to 30.075 JPY B (€270.75 million or $299 million) in development and commercial milestones. Celyad will also receive double digit royalties based on net sales of the licensed product in ONO’s territories.

Under the terms of the agreement, Celyad will continue developing its allogeneic NKR-2 T-cell immunotherapy in the EU and US territories, and ONO will be responsible for future development and commercialization in ONO’s territories (Japan, Korea and Taiwan). Both companies will also explore the opportunity to collaborate to collectively run global registration trials and combination trials. In addition, Celyad grants to ONO an exclusive option to license for development and commercialization of its autologous NKR-2 T cell product in the above ONO territories.

Dr. Christian Homsy, CEO of Celyad, said: "We are very pleased to collaborate with ONO and to activate the development of our NKR-2 T-cell allogeneic platform in Japan, Korea and Taiwan. This license agreement is a great opportunity for Celyad to expand the scope of its immuno-oncology clinical programs and bring this breakthrough science to numerous patients around the world. Further, this license agreement with ONO, the leader in immuno-oncology in Asia, validates our NKR-2 approach and its tremendous potential."

Georges Rawadi, VP Business Development of Celyad, said: "Celyad surrounds itself with the best immuno-oncology experts in the world to develop its NKR T-cell platform. This is why we have entered this agreement with ONO. Through this commercial license agreement, Celyad aims to expand the clinical and commercial potential of its allogeneic NKR-2 T-cell immunotherapies worldwide."
Gyo Sagara, President, Representative Director and CEO of ONO, said: "We are very delighted to collaborate with the leading cell therapy company, Celyad, for its distinct immuno-oncology candidates. Celyad’s NKR-2 is backed by cutting-edge science and we believe that it can be a new therapeutic option for patients who are not cured with existing therapies."

On July 11, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS) (Press release, CytRx, JUL 11, 2016, View Source;p=RssLanding&cat=news&id=2184496 [SID:1234513826]).

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In accordance with the FDA-granted special protocol assessment, the current analysis occurred following 191 progression events. Because enrollment was interrupted by a partial clinical hold in November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed. This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints. The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016. The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.

For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator’s choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study’s primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease ≥ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator’s choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

"While results from this current analysis are immature, a near doubling of response rates with aldoxorubicin suggests a highly active therapy which may benefit certain patients with soft tissue sarcoma," said Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California. "Because enrollment was interrupted by a clinical hold, both PFS and response data need to be analyzed at a future date to account for patients enrolled later in the trial. I look forward to this subsequent analysis providing a more complete understanding of aldoxorubicin’s potential in this very challenging disease."

Treatment-related adverse events for aldoxorubicin were consistent with those observed in prior studies. Aldoxorubicin was not associated with clinically significant cardiac, kidney or liver toxicities. The Company plans to present updated results of the study at an upcoming medical meeting.

"The complexity, in terms of tumor diversity and primary location, makes soft tissue sarcoma extremely difficult to treat, especially in the relapsed and refractory setting, resulting in few treatment advances over the last four decades," said Daniel Levitt, M.D., Ph.D., Executive Vice President and Chief Medical Officer of CytRx. "This first-of-its-kind study in STS included a comparator arm with multiple regimens, allowing for treatments to be matched to specific sarcoma subtypes. Despite a requirement for this challenging study design, aldoxorubicin demonstrated markedly greater activity over investigator’s choice therapy. That said, the unforeseen clinical hold that interrupted this study impacted the outcome of the current evaluation, underscoring a need for a subsequent analysis."

"In over 550 patients treated to date, aldoxorubicin has demonstrated anti-tumor activity in multiple tumor types and has shown a manageable safety profile," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "With approximately $68.2 million in cash and equivalents as of our last 10-Q filing, CytRx is funded through the next Phase 3 STS trial analysis and through a readout of our global Phase 2b trial of aldoxorubicin in small cell lung cancer. We are deeply grateful for the continued support and commitment of the patients, their families, the investigators and clinical support professionals participating in the Phase 3 trial."