On December 8, 2015 FUJIFILM Corporation (President: Shigehiro Nakajima) reported the progress in a Phase I clinical trial of anti-cancer agent FF-10501 in the United States in patients with relapsed or refractory myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) (Press release, Fujifilm, DEC 8, 2015, View Source [SID:1234508497]). The emerging results have revealed that to date FF-10501 was well tolerated in those patients and produced partial remission*1 and marrow complete remission*2 in some patients.

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These results were presented on December 7th at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting (Orland, Florida), the biggest hematology meeting in the world, by principal investigator, Professor Garcia-Manero MD, of The University of Texas MD Anderson Cancer Center*3 (MD Anderson Cancer Center hereafter).

MDS is a type of hematological malignancy, in which the disorder of blood-forming hematopoietic stem cells (myelodysplasia) causes inefficient production of blood cells triggering cytopenia. Current MDS patients in the United States and in Japan are estimated to be around 60,000 and 11,000, respectively, many of them in the senior age group. It is also a refractory disease progressing to AML for some patients with poor prognosis. AML is characterized by a higher rate of abnormal hematopoietic stem cells in bone marrow than in MDS, and inefficient production of blood cells and peripheral organ failure due to migrating myeloblasts. The numbers of patients with AML in the United States and in Japan are estimated to be around 25,000 and 6,000, respectively.

Fujifilm initiated the Phase I clinical trial of FF-10501 in patients with blood cancer at MD Anderson Cancer Center in the United States in August 2014. Although the trial is still underway, some positive responses have been observed in the study as follows:

– FF-10501 was well tolerated in all 17 patients〔AML (13), MDS (4)〕
– FF-10501 produced stable disease in 6 AML and 2 MDS patients
– FF-10501 produced 2 partial remissions in AML patients and 1 marrow complete remission in MDS patients

Fujifilm will continue the study to further evaluate tolerability and efficacies with higher doses at MD Anderson Cancer Center and proceed to early Phase IIa study.

Fujifilm tapped into the advanced technology to synthesize and design chemical compounds, nurtured through the development of photographic films, to develop FF-10501. The technology utilized in the development for enhancing its temporal stability and applying strong analysis technology to elucidate new mechanisms of action and identify biomarker candidates for verifying its efficacy. The agent is expected not only to inhibit the growth of hematological cancer cells but also promote their differentiation to cells with normal functions.

Fujifilm is dedicated to research and development for innovative pharmaceutical products and new production processes by combining the technologies and know-how accumulated in the photographic film business including chemical synthesis capacity, design ability, analysis technology, nanotechnology, and production technology, with the technological expertise of its pharmaceutical affiliates such as Toyama Chemical. Defining "oncology", a field with numerous unmet medical needs, as its focal area, the company will actively promote research and development to expand business deployment and supply innovative pharmaceutical products so as to contribute to resolving social issues.

On December 8, 2015 Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) reported that the U.S. Food and Drug Administration (FDA) has approved BENDEKA, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine (Press release, Teva, DEC 8, 2015, View Source;p=RssLanding&cat=news&id=2120888 [SID:1234508496]). BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

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"We are thrilled that the FDA has approved BENDEKA and are excited for what we believe will be a promising launch with Teva. Importantly, we believe that patients with CLL or indolent B-cell NHL that has progressed will benefit from the multiple administration options this product offers," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and healthcare providers," said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. "We are pleased to add BENDEKA to Teva’s Oncology portfolio, and bendamustine franchise, furthering our commitment to enhancing treatment options for patients affected by cancer."

BENDEKA was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.
Under the February 2015 exclusive license agreement for BENDEKA, Teva is responsible for all U.S. commercial activities for the product including promotion and distribution. Teva expects to make BENDEKA commercially available to prescribers during the first quarter of 2016.

Indications

BENDEKA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information

Contraindication: BENDEKA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.

Myelosuppression: Bendamustine hydrochloride caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle.

Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with Bendamustine hydrochloride are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment measures.

Anaphylaxis and Infusion Reactions: Infusion reactions to bendamustine hydrochloride have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.

Tumor Lysis Syndrome: Tumor lysis syndrome associated with bendamustine hydrochloride has occurred. The onset tends to be within the first treatment cycle with BENDEKA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when bendamustine hydrochloride and allopurinol are administered concomitantly.
Skin Reactions: Skin reactions have been reported with bendamustine hydrochloride treatment including rash, toxic skin reactions, and bullous exanthema. In a study of bendamustine hydrochloride (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when bendamustine hydrochloride was administered concomitantly with allopurinol and other medications known to cause these syndromes. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue BENDEKA.

Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine hydrochloride, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA therapy has not been determined.

Extravasation Injury: Extravasations resulting in hospitalizations from erythema, marked swelling, and pain have been reported with Bendamustine hydrochloride. Assure good venous access prior to starting drug infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.

Embryo-fetal Toxicity: Bendamustine hydrochloride can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.

Most Common Adverse Reactions:
• Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue
• Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
• Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
• Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

For BENDEKA Full Prescribing Information, please visit: View Source

On December 8, 2015 Pfizer Inc. reported the first-ever recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards (Press release, Pfizer, DEC 8, 2015, View Source [SID:1234508494]). Five grants totaling more than $4 million in funding were awarded to support clinical research projects investigating IBRANCE (palbociclib), an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, in advanced breast cancer for 2015. Simultaneously, the company announced that it will award up to $4 million in new grants through the ASPIRE Breast Cancer Research Awards Program in 2016.

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"We are excited to support these five investigator-led studies, which we believe will contribute important new information to our body of knowledge about the role IBRANCE plays in the treatment and clinical management of advanced breast cancer," said Dr. Julia Perkins Smith, senior medical director, U.S. Breast Cancer Lead, Pfizer Oncology. "At the same time, we are looking forward to continuing the program in 2016 and further supporting investigators’ efforts in this disease area, where there is a substantial need for research that may lead to new options and improved care for metastatic breast cancer patients. Supporting the scientific and clinical exploration of our medicines both within and outside our walls is critical to our ability to make a meaningful impact on patients’ lives."

The ASPIRE Breast Cancer Research Awards Program is an extension of ASPIRE, Pfizer’s competitive grants program. Recipients were selected through a competitive application process overseen by an independent review panel of breast cancer experts. The following five investigators and studies have been awarded grants through the program to date:

Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute – A Phase Ib/IIa Study of Palbociclib in Combination With Everolimus and Exemestane in Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer
Ewa Mrozek, MD, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute – A Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor or Operable Tumor but Cannot Undergo Surgery Due to Frailty

Oana Danciu, MD, University of Illinois at Chicago – A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Cesar Augusto Santa-Maria, MD, Northwestern University – A Single Arm Phase II Study of Palbociclib in Patients With Metastatic HER2-positive or Triple Negative Breast Cancer With Brain Metastasis

Filipa Lynce, MD, Lombardi Comprehensive Cancer Center at Georgetown University Medical Center – A Phase II Safety Study of Palbociclib in Combination With Letrozole in African American Women with Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

For the new 2016 grants, investigators are encouraged to submit for consideration proposals for innovative research in several areas. Some areas of research interest include:

Improving the medical knowledge of palbociclib in the treatment of advanced breast cancer through exploring the safety and efficacy of novel combinations

Optimizing clinical management during palbociclib treatment that addresses or improves patient compliance and convenience and/or patient reported outcomes

Exploring biomarkers relevant to palbociclib in breast cancer

For more information about the 2016 ASPIRE Breast Cancer Research Awards Program and specifics regarding eligible areas of research, please visit www.aspireresearch.org (link is external). The proposal submission period ends March 31, 2016.

About IBRANCE (palbociclib)

IBRANCE is an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression.1,2

IBRANCE is approved by the FDA for use in combination with letrozole as a treatment for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease.3 The effectiveness of IBRANCE in these patients is based on a study that measured progression-free survival.3 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled. The full prescribing information for IBRANCE can be found at www.IBRANCE.com (link is external).

IBRANCE has also received regulatory approval in Albania, Chile and Macau. In the European Union, the Marketing Authorization Application for IBRANCE, which is based on results from the PALOMA-1 and PALOMA-3 trials, is currently under review with the European Marketing Agency.

Important IBRANCE (palbociclib) Safety Information

Neutropenia: Neutropenia is frequently reported with IBRANCE therapy. In the randomized phase II study, Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. Febrile neutropenia can occur.

Monitor complete blood count prior to starting IBRANCE and at the beginning of each cycle, as well as Day 14 of the first two cycles, and as clinically indicated. For patients who experience Grade 3 neutropenia, consider repeating the complete blood count monitoring 1 week later. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Infections: Infections have been reported at a higher rate in patients treated with IBRANCE plus letrozole (55%) compared with letrozole alone (34%). Grade 3 or 4 infections occurred in 5% of patients treated with IBRANCE plus letrozole vs no patients treated with letrozole alone. Monitor patients for signs and symptoms of infection and treat as medically appropriate.

Pulmonary embolism (PE): PE has been reported at a higher rate in patients treated with IBRANCE plus letrozole (5%) compared with no cases in patients treated with letrozole alone. Monitor patients for signs and symptoms of PE and treat as medically appropriate.

Pregnancy and lactation: Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females with reproductive potential to use effective contraception during therapy with IBRANCE and for at least 2 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant or if pregnancy is suspected during treatment with IBRANCE. Advise women not to breastfeed while on IBRANCE therapy because of the potential for serious adverse reactions in nursing infants from IBRANCE.

Additional hematologic abnormalities: Decreases in hemoglobin (83% vs 40%), leukocytes (95% vs 26%), lymphocytes (81% vs 35%), and platelets (61% vs 16%) occurred at a higher rate in patients treated with IBRANCE plus letrozole vs letrozole alone.

Adverse reactions: The most common all causality adverse reactions (≥10%) of any grade reported in patients treated with IBRANCE plus letrozole vs letrozole alone in the phase II study included neutropenia (75% vs 5%), leukopenia (43% vs 3%), fatigue (41% vs 23%), anemia (35% vs 7%), upper respiratory infection (31% vs 18%), nausea (25% vs 13%), stomatitis (25% vs 7%), alopecia (22% vs 3%), diarrhea (21% vs 10%), thrombocytopenia (17% vs 1%), decreased appetite (16% vs 7%), vomiting (15% vs 4%), asthenia (13% vs 4%), peripheral neuropathy (13% vs 5%), and epistaxis (11% vs 1%).

Grade 3/4 adverse reactions reported (≥10%) occurring at a higher incidence in the IBRANCE plus letrozole vs letrozole alone group include neutropenia (54% vs 1%) and leukopenia (19% vs 0%). The most frequently reported serious adverse events in patients receiving IBRANCE were pulmonary embolism (4%) and diarrhea (2%).

General dosing information: The recommended dose of IBRANCE is 125 mg taken orally once daily for 21 days followed by 7 days off treatment in 28-day cycles. IBRANCE should be taken with food and in combination with letrozole 2.5 mg once daily continuously.

Patients should be encouraged to take their dose at approximately the same time each day.

Capsules should be swallowed whole. No capsule should be ingested if it is broken, cracked, or otherwise not intact. If a patient vomits or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time.

Management of some adverse reactions may require temporary dose interruption/delay and/or dose reduction, or permanent discontinuation. Dose modification of IBRANCE is recommended based on individual safety and tolerability.

Drug interactions: Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided.

Avoid concomitant use of strong and moderate CYP3A inducers. The dose of the sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

Hepatic and renal impairment: IBRANCE has not been studied in patients with moderate to severe hepatic impairment or in patients with severe renal impairment (CrCl <30 mL/min).

On December 8, 2015 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported financial results for the first quarter of fiscal year ended July 31, 2016 (Press release, OncoSec Medical, DEC 8, 2015, View Source [SID:1234508493]).

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FINANCIAL RESULTS
For the first quarter of fiscal 2016, OncoSec reported a net loss of $7.0 million, or $0.47 per share, compared to a net loss of $4.1 million, or $0.33 per share, for the same period last year. The net loss includes non-cash items such as stock compensation expense and depreciation. The increase in net loss for the quarter-ended October 31, 2015, resulted primarily from (i) additional outside services costs to support our development of next-generation device prototypes and clinical studies, (ii) additional reagent and lab supply costs to support discovery research, (iii) incremental legal and audit fees and (iv) an increase in non-cash stock-based compensation expense primarily related to our increased headcount. There were no revenues for the quarter-ended October 31, 2015 or October 31, 2014.

Research and development expenses were $3.7 million for the first quarter of fiscal 2016, compared to $2.5 million for the same period in fiscal 2015. General and administrative expenses were $3.4 million for the first quarter of fiscal 2016, compared to $1.6 million for the same period in fiscal 2015.

At October 31, 2015, OncoSec had $26.9 million in cash and cash equivalents, as compared to $32.0 million of cash and cash equivalents at October 31, 2014. OncoSec expects these funds to be sufficient to allow the Company to continue to operate its business for at least the next 12 months.

On December 8, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (OTCQX:ONCYF) (FRA:ONY) reported that Dr. D.W. Sborov and colleagues made a poster presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Oncolytics Biotech, DEC 8, 2015, View Source [SID:1234508492]). The poster presentation, titled "REOLYSIN Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma Patients," discloses updated findings from a pilot study (NCI-9603) in patients with relapsed or refractory multiple myeloma treated using the combination of carfilzomib and REOLYSIN. The ASH (Free ASH Whitepaper) Annual Meeting runs from December 5th to 8th in Orlando, FL.

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Highlights of the data presented include:

All seven patients treated at the full clinical dose had a clinical response. Patients treated at the full clinical dose (dose level 1) had a deeper and more prolonged response than those treated at dose level minus 1. Of the 12 total patients treated, 11 had a decrease in dominant monoclonal protein during treatment (used to measure clinical response), including all seven patients treated at the full clinical dose;

The combination of carfilzomib and REOLYSIN produced a significant (p=0.005) increase in caspase-3, a marker associated with apoptotic (programmed) cell death, but to a higher degree in those patients treated at dose level 1; and

The treatment combination was associated with an increased infiltration of CD8+ T-cells and the significant (p=0.005) upregulation of PD-L1, suggesting that the addition of a PD-1 or PD-L1 inhibitor may further optimize the treatment regimen.

"These findings are compelling as we continue to see a strong clinical benefit rate in this difficult to treat cancer, and clear evidence of a dose response, with patients at the higher dosing level seeing improved outcomes. We plan on testing higher dosage levels to determine the extent of this improvement," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "We recently announced a second study in multiple myeloma examining REOLYSIN together with bortezomib, with the goal of identifying the best standard of care combination to advance into later stage clinical testing."

The investigators noted that this is the first time a REOLYSIN-based combination has been tested in relapsed multiple myeloma patients. A previous single-agent study conducted by the collaborators in this patient population showed that REOLYSIN was well tolerated. The collaborators and others were noted to have conducted preclinical investigations that demonstrated that the combination of REOLYSIN and carfilzomib synergistically increased the killing of multiple myeloma cells. This provided the clinical rationale for this study.

"Based on these evolving data and input received from key opinion leaders, we believe multiple myeloma to be a compelling registration target," said Dr. Brad Thompson, President and CEO of Oncolytics. "We intend to discuss the design of a potential registration study with regulatory agencies."

NCI-9603 is a U.S. National Cancer Institute sponsored single-arm, open-label study of intravenously administered REOLYSIN with dexamethasone and carfilzomib to patients with relapsed or refractory multiple myeloma. Patients receive treatment on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle, to be repeated in the absence of disease progression or unacceptable toxicity. Approximately 12 patients will be enrolled in the study. The primary outcome measures include reovirus replication, safety, and tolerability. Secondary outcome measures include examining objective response, duration of response, clinical benefit, progression-free survival, and time to progression. Other outcome measures will include immunologic correlative markers.

A copy of the poster will be available on the Oncolytics website at: View Source

About Multiple Myeloma
Multiple Myeloma is a cancer of the plasma cells and the second most common hematological malignancy. The American Cancer Society estimates there will be 26,850 new cases diagnosed in the United States and 11,240 deaths from the disease in 2015.