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

BioCryst Pharmaceuticalsa has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioCryst Pharmaceuticals, MAY 8, 2015, View Source [SID1234503956]).

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

Genocea Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genocea Biosciences, MAY 8, 2015, View Source [SID1234503890]).

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CEL-SCI CORPORATION REPORTS SECOND QUARTER FISCAL YEAR 2015 FINANCIAL RESULTS

On May 8, 2015 CEL-SCI Corporation (NYSE MKT: CVM) reported financial results for the quarter ended March 31, 2015 (Filing, Q2, Cel-Sci, MAY 8, 2015, View Source [SID:1234506595]).

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Recent key clinical developments include:

Reported new record high patient enrollment numbers – 24 patients in January, 25 patients in February and 29 patients in March in the Phase III head and neck cancer trial; with continued increase post-Q2 of 31 patients in April.

A total of four hundred thirty-seven (437) patients have been enrolled in the Phase III study as of April 30, 2015.

Trial received clearance in Romania, the Philippines, Malaysia and Belarus.

Reached milestone of trial approval in 21 countries as originally planned; trial to expand into additional countries based on strong interest.

Continued patient enrollment in the Phase I trial in HIV/HPV co-infected men and women with peri-anal warts at San Diego Naval Medical Center.

"We have enrolled approximately half of the 880 patients planned for our Phase III head and neck cancer trial. Twenty-one countries have cleared the trial and clinical centers around the world are actively recruiting patients. We are pleased with the progress we have made. Our CROs are putting forth their best efforts to complete patient recruitment by the end of 2015. We are conservatively estimating completion in the first quarter of 2016," stated CEL-SCI Chief Executive Officer Geert Kersten.

CEL-SCI reported an operating loss of ($7,759,343) for the quarter ended March 31, 2015 versus an operating loss of ($6,226,435) for the quarter ended March 31, 2014. The operating loss for the six months ended March 31, 2015 was ($17,755,084) versus ($12,160,745) during the six months ended March 31, 2014. The rise in operating loss was attributable to an increase in research and development expenses of approximately $1,717,000 in the first half of fiscal year 2015 compared to the first half of fiscal year 2014. R&D expenses increased primarily because of the increase in patient enrollment in the Company’s Phase 3 clinical study for head and neck cancer. In addition, the general and administrative expenses increased by approximately $4,027,000 for the first half of fiscal year 2015 compared to the first half of fiscal year 2014. G&A expenses increased primarily because of an increase of approximately $3,043,000 in employee compensation costs related to the issuance of shareholder approved shares of restricted stock and an increase in legal fees of approximately $872,000 primarily related to the arbitration with the Company’s former clinical research organization (CRO).

CEL-SCI’s net loss available to common shareholders for the quarter ended March 31, 2015 was ($12,556,236) or ($0.17) per basic share, versus ($13,365,580) or ($0.24) per basic share during the quarter ended March 31, 2014. The net loss available to common shareholders for the six months ended March 31, 2015 was ($20,401,554) or ($0.27) per basic share, versus ($18,817,445) or ($0.36) per basic share during the same six months ended March 31, 2014. The increase in net loss for the three and six month periods of 2015 as compared to the same periods in 2014 was primarily attributable to the increase in operating loss off-set by the reduced loss reported of the non-cash charge for the change in value of derivative instruments caused by a decrease in the Company’s common stock.

About Multikine

Multikine* (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would 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. The trial is expected to expand into a total of approximately 100 clinical centers in about 25 countries.

Multikine is also being tested in a Phase I study under a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has entered into two co-development agreements with Ergomed 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.

National Cancer Center of Japan and Takeda Partner to Discover Anti-Cancer Agents

On May 8, 2015 The National Cancer Center and Takeda reported that they have signed an agreement with the goal to discover and develop superior, innovative anti-cancer agents originated in Japan and deliver them to cancer patients and their families as quickly as possible (Press release, Takeda, MAY 8, 2015, View Source [SID:1234503901]).

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The objectives of the agreement are to contribute to the development of basic research including studies on pathogenesis and drug susceptibility of cancer by promoting exchanges among researchers, physicians, and others engaged in anti-cancer drug discovery and cancer biology research. Takeda and the NCC have agreed to share information and hold regular discussions in order to collaborate and transition findings from basic research to clinical research and development activities, leveraging the strengths of both parties.

Furthermore, in an effort to deepen their cooperation, Takeda has participated in the national academic-industrial collaboration genomic screening project "SCRUM-Japan"* led by the NCC. This project involves nation-wide medical institutions and pharma industry to collaborate to screen oncogene abnormalities. Through access of the genetic and medical information database generated by this project Takeda and NCC expect research and development of new medicines will be accelerated.

"NCC is expecting a lot to be newly created by exchanging an agreement for the partnership with Takeda," said Hitoshi Nakagama, M.D., Director, National Cancer Center Research Institute. "By sharing bio-resources, including various types of cancer cell lines and animal models, biological and biochemical techniques for functional screenings, and huge amounts of clinical materials attached with detailed pathological and clinical information, further acceleration for development of Japan-oriented novel medicine and diagnostics is expected to be promptly achieved."

"Takeda is so pleased to partner with the NCC," said Michael Vasconcelles, M.D., Head, Oncology Therapeutic Area Unit, Takeda. "By leveraging NCC’s clinical research with Takeda’s technology infrastructure and tools for drug discovery, we hope that together we can have greater impact in a shorter amount of time to bring innovative treatments to the oncology community."

*For details, please refer to the National Cancer Center’s press release issued on March 10.
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Novartis lung cancer drug Zykadia® gains EU approval, providing new therapy for certain patients with ALK+ NSCLC

On May 8, 2015 Novartis reported that the European Commission has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib[1] (Press release, Novartis, MAY 8, 2015, View Source [SID:1234503882]). The approval of Zykadia in the European Union (EU) provides patients with advanced ALK+ NSCLC previously treated with crizotinib a new treatment option that specifically targets the genetic makeup of their cancer.

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"Molecular testing for genetic drivers in lung cancer plays a critical role as patients and physicians determine how to proceed with therapies, especially after they have experienced disease progression following initial treatment," said Stefania Vallone, international relations, Women Against Lung Cancer in Europe and board member, Lung Cancer Europe (LuCE). "Patients with resistant ALK+ NSCLC have had very few treatment options available that specifically target the genetic makeup of their disease. The approval of Zykadia brings new hope to the lung cancer community as we continue to advocate for innovative therapies."

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Each year, there are 1.6 million people diagnosed worldwide with lung cancer, the leading cause of cancer death[2]. The most common type of lung cancer is NSCLC, accounting for 85-90% of all cases[3]. Of those, 2-7% are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumor[4]. Despite significant treatment advances for patients with ALK+ NSCLC, disease progression is often inevitable and more treatment options are needed[5].

The EU approval of Zykadia is based on data from two global, multicenter, open-label, single-arm studies [Study A (also known as ASCEND-1) and Study B (also known as ASCEND-2)]. Data from Study A demonstrated patients with ALK+ NSCLC who received Zykadia 750 mg daily after previous treatment with chemotherapy followed by an ALK inhibitor experienced an overall response rate (ORR) of 56.4%[1]. Detailed results from Study B will be presented at an upcoming medical congress.

"The approval of Zykadia in the European Union is significant for ALK+ NSCLC patients who have exhausted the other treatment options for their disease," said Bruno Strigini, President, Novartis Oncology. "This approval is yet another example of our commitment to precision oncology and our continued focus on developing treatment approaches that target specific genetic and molecular characteristics of cancer."

The EU approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in February 2015 and applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. Outside the EU, Zykadia is approved in the United States and other countries within North America, South America, Central America and Asia. Additional regulatory reviews for Zykadia are underway worldwide.

About the Zykadia Clinical Trials
The primary efficacy endpoint for these studies was overall response rate (ORR), including complete response and partial response, for patients who were treated with a 750 mg dose of Zykadia, confirmed by repeat assessments performed not less than four weeks after the criteria for response was first met. Additional evaluations included duration of response (DOR), progression-free survival (PFS) and overall survival (OS). Tumor evaluations were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 in Study A and RECIST 1.1 in Study B. Tumor-related endpoints (ORR, DOR and PFS) were assessed by investigator and by blinded independent review committee (BIRC). Comparative efficacy data from randomized clinical studies are not available[1].

Study A was a Phase I study, which included a dose-escalation phase and an expansion phase at the recommended dose of 750 mg. The study evaluated a total of 246 ALK+ NSCLC patients who were treated with 750 mg of Zykadia: 163 had received prior treatment with an ALK inhibitor and 83 were ALK inhibitor-naïve. In patients who had previously received treatment with an ALK inhibitor, the ORR was 56.4% [95% CI, 48.5-64.2%], the median DOR was 8.3 months [95% CI, 6.8-9.7 months] and the median PFS was 6.9 months [95% CI, 5.6-8.7 months] based on investigator assessment[1].

Study B was a Phase II study designed to evaluate the efficacy and safety of 750 mg Zykadia in patients with locally advanced or metastatic ALK+ NSCLC. Study B evaluated 140 patients who had been previously treated with one to three lines of chemotherapy followed by treatment with crizotinib, and who had then progressed on crizotinib[1]. Detailed results from Study B will be presented at an upcoming medical congress.

In Studies A and B, brain metastases at baseline were seen in 60.1% and 71.4% of patients who had received prior treatment with an ALK inhibitor, respectively. The ORR, DOR and PFS by BIRC assessment for patients with brain metastases at baseline were similar with those reported for the overall population of these studies[1].

The most common adverse reactions with an incidence of >=10% were diarrhea, nausea, vomiting, tiredness (fatigue), liver laboratory test abnormalities (requires blood test monitoring), abdominal pain, decreased appetite, constipation, rash, kidney laboratory test abnormalities (requires blood test monitoring), heartburn and anemia. Grade 3-4 adverse reactions with an incidence of >=5% were liver laboratory test abnormalities, tiredness (fatigue), diarrhea, nausea and hyperglycemia (requires blood test monitoring)[1].

About Zykadia

Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal "fusion protein" that promotes the development and growth of certain tumors in cancers including non-small cell lung cancer (NSCLC). Zykadia is approved by the European Commission for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Outside the European Union, Zykadia is approved for patients with ALK+ NSCLC in the United States and other countries within North America, South America, Central America and Asia. Additional regulatory reviews for Zykadia are underway worldwide.

Zykadia Important Safety Information
Zykadia may cause serious side effects.

Zykadia may cause stomach upset and intestinal problems in most patients, including diarrhea, nausea, vomiting and stomach-area pain. These problems can be severe. Patients should follow their doctor’s instructions about taking medicines to help these symptoms, and should call their doctor for advice if symptoms are severe or do not go away.

Zykadia may cause severe liver injury. Patients should have blood tests prior to the start of treatment with Zykadia, every two weeks for the first month of treatment and monthly thereafter, and should talk to their doctor right away if they experience any of the following symptoms: tiredness (fatigue), itchy skin, yellowing of the skin or the whites of the eyes, nausea or vomiting, decreased appetite, pain on the right side of the abdomen, urine turns dark or brown, or bleeding or bruising more easily than normal.

Zykadia may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those symptoms from lung cancer. Patients should tell their doctor right away about any new or worsening symptoms, including trouble breathing or shortness of breath, fever, cough, with or without mucous, or chest pain.

Zykadia may cause very slow, very fast, or abnormal heartbeats. Doctors should check their patient’s heart during treatment with Zykadia. Patients should tell their doctor right away if they feel new chest pain or discomfort, dizziness or lightheadedness, faint, or have abnormal heartbeats, blue discoloration of lips, shortness of breath, swelling of lower limbs or skin, or if they start to take or have any changes in heart or blood pressure medicines.

Zykadia may cause high levels of glucose in the blood. People who have diabetes or glucose intolerance, or who take a corticosteroid medicine have an increased risk of high blood sugar with Zykadia. Patients should have glucose blood tests prior to the start of treatment with Zykadia and during treatment. Patients should follow their doctor’s instructions about blood sugar monitoring and call their doctor right away with any symptoms of high blood sugar, including increased thirst and/or urinating often.

Before patients take Zykadia, they should tell their doctor about all medical conditions, including liver problems; diabetes or high blood sugar; heart problems, including a condition called long QT syndrome; if they are pregnant, if they think they may be pregnant, or if they plan to become pregnant; are breastfeeding or plan to breastfeed.

Zykadia may harm unborn babies. Women who are able to become pregnant must use a highly effective method of birth control (contraception) during treatment with Zykadia and up to 3 months after stopping Zykadia. It is not known if Zykadia passes into breast milk. Patients and their doctor should decide whether to take Zykadia or breastfeed, but should not do both.

Patients should tell their doctor about medicines they take, including prescription medicines, over-the-counter medicines, vitamins and herbal supplements. If they take Zykadia while using oral contraceptives, the oral contraceptives may become ineffective.

The most common adverse reactions with an incidence of >=10% were diarrhea, nausea, vomiting, tiredness (fatigue), liver laboratory test abnormalities (requires blood test monitoring), abdominal pain, decreased appetite, constipation, rash, kidney laboratory test abnormalities (requires blood test monitoring), heartburn and anemia. Grade 3-4 adverse reactions with an incidence of >=5% were liver laboratory test abnormalities, tiredness (fatigue), diarrhea, nausea and hyperglycemia (requires blood test monitoring).

Patients should stop taking Zykadia and seek medical help immediately if they experience any of the following, which may be signs of an allergic reaction:

Difficulty in breathing or swallowing
Swelling of the face, lips, tongue or throat
Severe itching of the skin, with a red rash or raised bumps
Patients should tell their doctor of any side effect that bothers them or does not go away. These are not all of the possible side effects of Zykadia. For more information, patients should ask their doctor or pharmacist.

Patients should take Zykadia exactly as their health care provider tells them. Patients should not change their dose or stop taking Zykadia unless their health care provider advises them to. Zykadia should be taken once a day on an empty stomach. Patients should not eat for at least 2 hours before and 2 hours after taking Zykadia. If a dose of Zykadia is missed, they should take it as soon as they remember. If their next dose is due within the next 12 hours, they should skip the missed dose and take the next dose at their regular time. They should not take a double dose to make up for a forgotten dose. Patients should not drink grapefruit juice or eat grapefruit during treatment with Zykadia, as it may make the amount of Zykadia in their blood increase to a harmful level. If patients have to vomit after swallowing Zykadia capsules, they should not take more capsules until their next scheduled dose.