On November 29, 2018 Genomic Health, Inc. (NASDAQ: GHDX) and the NSABP Foundation reported the publication of positive results from a new analysis of the NSABP-led B-20 study reconfirming that the Oncotype DX Breast Recurrence Score test predicts which patients with early-stage, HER2-negative breast cancer will benefit from chemotherapy (Press release, Genomic Health, NOV 29, 2018, View Source [SID1234531720]).

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Applying the patient criteria from the TAILORx study, the largest ever breast cancer treatment trial, sponsored by the National Cancer Institute (NCI), and led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), NSABP conducted a new analysis in 569 patients from its previously completed B-20 study. The results show that Oncotype DX provides definitive information about which patients will derive life-saving benefit from chemotherapy treatment.

"We previously had an unprecedented amount of data on patients with Oncotype DX Breast Recurrence Score results of 25 or lower, and now with the results from TAILORx and the new B-20 analysis, we have critical confirmation for patients with scores over 25 that they should be treated with chemotherapy," said Norman Wolmark, M.D., chairman of the NSABP Foundation in Pittsburgh, Pennsylvania. "Our publication underscores the important clinical value of the Oncotype DX test in guiding treatment decision in every early-stage, HER2-negative breast cancer patient."

The new results, published in November in the Nature Partner Journals (NPJ) Breast Cancer, show a statistically significant (p < 0.001) benefit from the addition of chemotherapy to hormonal therapy in patients with Breast Recurrence Score results greater than 25.

About 50 percent of all breast cancer patients diagnosed worldwide each year have hormone-receptor positive, HER2-negative, node-negative cancer. The TAILORx study, published in The New England Journal of Medicine, definitively established that chemotherapy may be spared in the majority of these patients. Importantly, some early-stage breast cancer patients – as reinforced by the new NSABP publication – will derive life-saving benefit from chemotherapy, including women with Breast Recurrence Score results of 26 to 100. TAILORx participants with Breast Recurrence Score results from 26 to 100 were treated with chemotherapy plus endocrine therapy.

"The new B-20 study analysis, combined with the published results from TAILORx, provide unparalleled evidence from randomized patients that Oncotype DX can predict which patients will benefit from chemotherapy," said Steven Shak, M.D., chief scientific officer and chief medical officer, Genomic Health. "Also recognized by the National Comprehensive Cancer Network (NCCN) as the only multi-gene test to predict chemotherapy benefit, physicians can now tell every patient more confidently, based on Oncotype DX, whether they should receive chemotherapy or not."

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to AR-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On November 29, 2018 Noxopharm (ASX: NOX) reported the final results from its Phase 1b CEP-1 trial evaluating its lead immuno-oncology/radio-enhancer drug candidate, Veyonda, in combination with low-dose carboplatin in late-stage metastatic solid cancers (Press release, Noxopharm, NOV 29, 2018, View Source [SID1234531738]).

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The CEP-1 trial was a first-in-human study for Veyonda and was designed to confirm the safety of Veyonda both as a monotherapy and in combination with chemotherapy, as well as patient and doctor acceptance of the treatment regimen. The study, which ran between January 2017 and July 2018, was managed by a UK-based clinical research organisation and conducted in the European country of Georgia at sites subject to FDA audit. Top line data was presented earlier at the Clinical Oncology Society of Australia (COSA) Annual Meeting on 13 November 2018. With the Final Report now received, the Company is able to comment on the outcome, in particular, the effect of treatment on cancer progression.

The topline outcomes of the study are:

Veyonda was well tolerated as a monotherapy, with just 1 case of anemia attributed to it
Veyonda at 400mg and 800 mg dosages did not exacerbate carboplatin toxicity
A combination of Veyonda and low-dose carboplatin provided suspension of tumour growth, or better, for at least 6 months in solid tumours (breast, ovarian, lung, prostate) in nearly 50% of patients considered unlikely to respond to further chemotherapy
The Company believes that the response rate and ongoing survival of patients post-study, suggests that a meaningful increase in survival is achievable and therefore worthy of consideration of an eventual marketing approval process
The Company also believes that this points to a combination of Veyonda and low-dose carboplatin as offering a potential treatment option for those cancer patients considered too unwell to undergo chemotherapy and/or unlikely to respond to chemotherapy because of their cancer becoming unresponsive to chemotherapy.
Study details. CEP-1 recruited 19 subjects with late-stage metastatic solid cancers (breast, ovarian, lung, prostate) who had stopped responding to chemotherapy, including carboplatin, and for whom no remaining standard treatment options were available. All patients entered the study with progressive disease and were assessed as having limited survival prospects. Subjects were administered Veyonda as a monotherapy for the first month and then in combination with two dosages of carboplatin (3 cycles of carboplatin followed by 3 cycles of carboplatin at 50% and 75% respectively of a standard dose) over six months, producing a 7-month treatment course in full.

Safety: With the exception of one (1) patient who displayed hypersensitivity to carboplatin at the initial injection, in no case was toxicity severe enough to require combination therapy needing to be withheld or have the dosage reduced.

Overall, 83% of patients experienced 1 or more adverse events, the majority during combination therapy. The most common events were anaemia (low red blood cells), neutropenia (low white blood cells) and hypocalcemia (low blood calcium levels). 95% of events occurred during combination therapy, of which 80% were attributed to carboplatin. One (1) severe case of anaemia was reported during monotherapy and possibly attributed to Veyonda.

Cancer status: A high proportion of patients showed tumour responses ranging from stable disease (a halt in disease progression) to partial response (decreased tumour load), despite a patient population that was heavily pre-treated with chemotherapy and assessed as ineligible for further treatment. Individual efficacy results for patients assessable after 3 cycles of combination therapy (left figure) and after 6 cycles (right figure) are detailed in the figure below. Bars reflect the change in total tumor(s) size for each patient and annotations show categorical response according to RECIST 1.1 criteria (PR = partial response; SD = stable disease; PD = progressive disease) for the same patients. Fourteen patients completed 3 cycles and were able to be assessed; 8 completed 6 cycles and were able to be assessed.

At 3-months, 10 of 14 patients had shown no tumour progression; 8 of these were evaluable after a further 3 cycles (6 cycles total) and of these, 6 patients had shown no disease progression at the end of the study, including one partial responder with an almost 100% reduction in tumour size.

Two photos accompanying this announcement are available at
View Source
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Rationale: The active ingredient in Veyonda, idronoxil, restores sensitivity to carboplatin in cancer cells that have stopped responding to carboplatin after multiple courses of treatment. The rationale of the CEP program is that Veyonda will restore sensitivity to chemotherapy or will act synergistically with chemotherapy, such that the dosage of chemotherapy can be lowered to a tolerable level, if required. The ultimate objective is to utilize Veyonda as a chemo-sensitizer to provide meaningful anti-cancer effects while avoiding serious side-effects that are often treatment-limiting, particularly in in patients considered too unwell to undergo cancer therapy. The CEP regimen also offers the prospect of improving tolerability of chemotherapy regimens in children, where successful treatment with chemotherapy can come at the cost of toxicities with long-term sequelae.

Comments: "The CEP-1 data are highly encouraging, suggesting that in addition to serving as a potential enhancer of radiotherapy, Veyonda appears to have broader utility as an enhancer of chemotherapy as well," said Greg van Wyk M.D., Noxopharm Chief Medical Officer. "Chemotherapy-induced toxicity remains a significant challenge for patients and oncologists that can lead to long-lasting and debilitating side effects, such as peripheral nerve damage and hearing loss. We are hopeful that combining Veyonda with a lower than normal dosage of chemotherapy will provide a more tolerable treatment option for patients who have chemotherapy-resistant disease or who are only able to tolerate lower doses of chemotherapy."

Graham Kelly Ph.D., Noxopharm Chief Executive Officer, said, "We believe that this result goes a considerable way to confirming the good tolerability and efficacy of Veyonda. A high incidence of an anti-cancer effect in such a highly treatment-resistant patient population is very pleasing. The context here is that these patients had progressive disease, had exhausted standard treatment options, and were facing a limited lifespan. To be able to stop tumour growth or to even shrink the tumours in many of these patients over the 7 months of this study, and to do so without significant side-effects, substantiates the faith we have in this drug becoming an important addition to standard anti-cancer therapy."

"Noxopharm is committed to bringing Veyonda to market as a radio-enhancer with a strategy that we believe will see it on-market by 2022, but the CEP-1 outcome adds another dimension to our overall clinical and marketing strategies," Kelly added.

The Company now will consult with its advisors on a Phase 2 CEP study in Australian cancer patients, although its primary focus remains on its DARRT and LuPIN programs as being the likely quickest routes to market.

A family of three patents surrounding Veyonda, including one pertaining to use with chemotherapy, has entered the global national phase following a review by the International Examiner.

About Veyonda

Veyonda (previously known as NOX66) is an innovative dosage formulation of the experimental anti-cancer drug, idronoxil, developed specifically to preserve the anti-cancer activity of idronoxil in the body and to enhance its drug-like behaviour. Idronoxil is a kinase inhibitor that works by inhibiting a range of enzymes, pre-eminent among which is sphingosine kinase, a key regulator of cell pro-survival mechanisms, and which is over-expressed in many cancer cells. Idronoxil also is an immuno-oncology drug, activating the body’s innate immune system e.g. natural killer (NK) cells.

About CEP

The Company’s CEP Program (Chemotherapy Enhancement Program) is testing the ability of Veyonda to restore sensitivity of cancer cells to carboplatin in patients whose late-stage cancers have stopped responding to chemotherapy, and to do that to the extent that the dosage of carboplatin can be lowered to a level unlikely to cause serious adverse side-effects. The clinical outcome being sought is the ability to offer a well-tolerated chemotherapy regimen to patients considered unsuitable for standard dosage due to age or illness.

On November 28, 2018 Oncorus, Inc., an oncolytic virus company focused on driving innovation to transform outcomes for cancer patients, reported the nomination of ONCR-177, a next-generation locally administered oncolytic virus clinical candidate for multiple solid tumor indications (Press release, Oncorus, NOV 28, 2018, View Source [SID1234531681]). ONCR-177 utilizes Oncorus’ proprietary, next-generation oncolytic herpes simplex virus (oHSV) platform. In addition, Oncorus has created a unique synthetic oncolytic virus platform, which will enable the company to develop multiple oncolytic viruses for repeated, systemic administration. Proprietary innovations in potency and safety engineered by Oncorus into both platforms enable best-of-class potential for the company’s portfolio programs and the opportunity to pursue multiple cancer types.

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"While we’ve seen early promise of the ability of oncolytic virus therapies to improve the response rates of checkpoint inhibitors, many patients still do not respond to these agents. Our team is committed to changing this fact," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We are driving multiple proprietary innovations across two distinct platforms that are enabling a portfolio of oncolytic virus product candidates with best-in-class potential. We intend to become the leaders in realizing the full potential of this exciting treatment modality to dramatically transform outcomes for cancer patients."

Dr. Ashburn will give an update on the company’s pipeline and business at a presentation today at 7:30 AM EST at the Piper Jaffray 30th Annual Health Care Conference in New York City, highlighting key accomplishments from 2018 to date and outlining near- and long-term value drivers for the company.

Key 2018 Accomplishments:

Nomination of lead clinical candidate, ONCR-177. Oncorus recently nominated a lead clinical candidate, ONCR-177, a locally administered oncolytic virus therapy. ONCR-177 features key innovations engineered into Oncorus’ next-generation oHSV platform, including the largest number of immunomodulatory payloads in the class. These payloads include IL-12, FLT3L, CCL4 and antagonists of the clinically proven checkpoint inhibitors, CTLA-4 and PD-1, to enable the recruitment and activation of T cells, natural killer (NK) cells and dendritic cells and increase the likelihood of productive anti-tumor responses. ONCR-177 is also a fully-replication competent virus in that it retains the ability to expresses γ34.5, which allows the virus to replicate in the presence of host antiviral immune responses, a feature unique among oHSVs that have been developed to date or are being developed currently. ONCR-177 also features Oncorus’ proprietary microRNA-attenuation strategy, which leverages the differential expression of microRNA sequences to allow robust viral replication in tumor cells, while preventing replication in healthy tissue. In addition, Oncorus has developed a complementary and orthogonal approach to protecting neurons from viral infection by engineering mutations in UL37, an HSV protein, which prevent both axonal retrograde transport and latency.
The company intends to file an investigational new drug application (IND) and start a first-in-human study by the end of 2019 in order to evaluate ONCR-177 in multiple solid tumor indications.

"The promise of oncolytic viruses as a therapeutic tool in the fight against cancer has been clear for some time. However, a fundamental challenge to date has been the need to sacrifice potency to ensure safety," said Christophe Quéva, Ph.D., Oncorus’ Chief Scientific Officer. "Our team has been working diligently to enhance our oHSV platform in a number of innovative ways to successfully overcome this ‘potency versus safety’ tradeoff. We are very encouraged by our progress to date and look forward to seeing how our innovations improve outcomes in clinical studies involving ONCR-177."

Achieved in vivo proof-of-concept for synthetic virus program for repeat, systemic administration. Oncorus has made notable progress advancing its research programs for systemic intravenous delivery for its breakthrough synthetic virus platform. Systemic delivery of oncolytic viruses offers the promise of targeting indications not amenable to locally administered oncolytic virus therapy such as cancers of the lung. The company recently achieved in vivo proof-of-concept for its systemic virus platform and aims to nominate a lead clinical candidate synthetic virus by the end of 2019.
Solidified leadership with key hires. Oncorus made key management hires in 2018 that helped expand the company’s expertise, solidify its leadership team, and position it for rapid growth. In September, the company announced that Theodore (Ted) T. Ashburn, M.D., Ph.D., was appointed President and CEO. Dr. Ashburn brings a wealth of experience in immuno-oncology drug development and commercialization to Oncorus. Mitchell H. Finer, Ph.D., Oncorus’ co-founder, founding CEO and MPM Capital Managing Director, assumed the role of Executive Chairman. Other key hires include John Goldberg, M.D., Senior Vice President, Clinical Development; Brett Belongia, Ph.D., Senior Director of CMC; Brian Haines, Ph.D., Senior Director Pharmacology, Toxicology; and Tooba Cheema, Ph.D., Director of Biomarkers and Translational Medicine.
Closed the third and final tranche of Series A round of financing. Oncorus closed a third and final tranche of its Series A financing, which raised a total of $61.4 million. The company’s blue-chip investor syndicate includes founding investor MPM Capital, as well as MPM’s UBS Oncology Impact Fund (OIM), Deerfield Management, Arkin Bio Ventures, Long March, Astellas and Celgene.
Continued to build a robust intellectual property (IP) estate. Oncorus continued to pursue a broad IP strategy and augment its current patent estate surrounding its proprietary innovations for both its oHSV and synthetic virus platforms and respective applications.
2019 Goals:

Oncorus’ key goals and upcoming value drivers include:

Filing an IND and initiating a first-in-human Phase 1 study involving ONCR-177
Nominating a lead synthetic virus clinical candidate for repeat systemic administration, and
Continuing to expand its team with the recruitment of key talent across multiple disciplines
"It’s an exciting time to be in the oncolytic virus therapy space, given the continued progress of this modality and its potential to become an important addition to the arsenal of immuno-oncology therapies available to cancer patients," said Dr. Finer. "2018 has been a year of important growth for Oncorus on both the scientific and business fronts. We have clear momentum as we approach 2019 and look forward to transitioning into a clinical stage company, progressing our portfolio of best-in-class products and, above all, realizing the promise of oncolytic virus therapy for cancer patients."

On November 28, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that nine abstracts, including two oral presentations, relating to the company’s hematology/oncology portfolio were accepted for the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego from December 1-4 (Press release, Jazz Pharmaceuticals, NOV 28, 2018, View Source;p=RssLanding&cat=news&id=2378498 [SID1234531666]).

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"We look forward to showcasing our commitment to the hematology/oncology community at ASH (Free ASH Whitepaper) by advancing the science and addressing the clinical needs of patients with blood cancers and with complications of stem cell transplantation," said Allen Yang, M.D., Ph.D., head of clinical development and acting chief medical officer of Jazz Pharmaceuticals. "We’ve made great progress in the last year with the initiation of new clinical trials for Vyxeos and Defitelio, the marketing authorization of Vyxeos in the European Union, and a collaboration with MD Anderson Cancer Center to evaluate potential treatment options for hematologic malignancies."

Jazz Pharmaceuticals data at the 2018 ASH (Free ASH Whitepaper) Annual Meeting will highlight the following:
Results from a post-hoc analysis from the pivotal Phase 3 randomized trial of Vyxeos (daunorubicin and cytarabine) liposome for injection, also known as the molecule name CPX-351, in a subgroup of older patients with newly diagnosed high risk (secondary) AML with myelodysplasia-related changes (AML-MRC) that evaluated the efficacy of Vyxeos compared to conventional 7+3 chemotherapy on overall survival and remission rates as well as the safety profile in older adults with AML-MRC. Additionally, data will be presented from an exploratory analysis which evaluated the impact of hematopoietic cell transplantation (HCT) on survival in patients treated with Vyxeos compared to 7+3 in the Phase 3 trial.

Vyxeos abstracts include:

Efficacy and Safety of CPX-351 versus 7+3 in a Subgroup of Older Patients with Newly Diagnosed Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Enrolled in a Phase 3 Study [Abstract #1425; Saturday, December 1, 6:15 PM – 8:15 PM PST]
Population Pharmacokinetic (PK)/Pharmacodynamic (PD) Modeling of Myelosuppression in Patients with Hematologic Malignancies for CPX-351 and Standard-of-Care 7+3 Therapy [Abstract #4037; Monday, December 3, 6:00 PM – 8:00 PM PST]
The Impact of Hematopoietic Cell Transplantation on Survival: An Exploratory Analysis of a Phase 3 Study of CPX-351 versus 7+3 in Older Patients with Newly Diagnosed, High-Risk/Secondary AML [Abstract #2706; Sunday, December 2, 6:00 PM – 8:00 PM PST]
Final Safety and Efficacy Results from the CPX-351 Early Access Program (EAP) for Older Patients with High-Risk/Secondary Acute Myeloid Leukemia (sAML) [Abstract #1434; Saturday, December 1, 6:15 PM – 8:15 PM PST]
Impact of Post–Hematopoietic Cell Transplant (HCT) Survival on Cost-effectiveness of CPX-351 versus 7+3 in the Treatment of Therapy-Related AML or AML-MRC in the United States (online only)
A Phase I/Pilot Study of CPX-351 [Daunorubicin and Cytarabine Liposome for Injection (Vyxeos)] for Children, Adolescents and Young Adults with Recurrent or Refractory Acute Leukemia [Abstract #336; Sunday, December 2, 10:45 AM PST(oral presentation)]
In addition, data from an expanded access program and post-hoc analyses of clinical trials for Defitelio (defibrotide sodium) will be presented, including an oral presentation of a pooled analysis of survival based on timing of initiation in adults with Veno-Occlusive Disease/ Sinusoidal Obstruction Syndrome (VOC/SOS) following hematopoietic stem cell transplant (HSCT).

Defitelio abstracts include:

Incidence of Post-Hematopoietic Stem Cell Transplantation (HSCT) Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) Without Hyperbilirubinemia at Diagnosis and Efficacy of Defibrotide in an Expanded-Access Program [Abstract #2080; Saturday, December 1, 6:15 PM – 8:15 PM PST]
A Pooled Analysis of Survival by Defibrotide Timing of Initiation in Adults with Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) Following Hematopoietic Stem Cell Transplant (HSCT) [Abstract #815; Monday, December 3, 3:45 PM PST (oral presentation)]
Cost-Effectiveness of Defibrotide for the Treatment of Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) with Multi-Organ Dysfunction (MOD) Post-Hematopoietic Stem Cell Transplantation (HSCT) in Canada [Abstract #4702; Monday, December 3, 6:00 PM – 8:00 PM PST]
About Vyxeos
Vyxeos (daunorubicin and cytarabine) is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion, and is approved for the treatment of two types of secondary AML in adult patients, newly diagnosed therapy-related acute myeloid leukaemia (t-AML) and AML with myelodysplasia-related changes (AML-MRC). Vyxeos is the first product developed with the company’s proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos received U.S. FDA approval and orphan drug exclusivity in August 2017 and EU EMA marketing authorization in August 2018. Vyxeos received Orphan Drug Designation for the treatment of AML by the U.S. FDA in September 2008 and by the European Commission in January 2012 (with retention of the designation reaffirmed in July 2018). Vyxeos received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom.

Important Safety Information
Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles or legs
unusual tiredness
Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
Vyxeos contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Please see full Prescribing Information for Vyxeos including BOXED Warning, and visit www.Vyxeos.com for additional information.

About Defitelio
In the U.S., Defitelio (defibrotide sodium) injection 80mg/mL received U.S. FDA marketing approval on March 30, 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication.

In Europe, defibrotide is marketed under the name Defitelio* (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients undergoing HSCT therapy. It is the first and only approved treatment in Europe for severe VOD. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

*This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC. (View Source)

Important Safety Information

Defitelio should not be given to patients who are:

Currently taking anticoagulants or fibrinolytics
Allergic to Defitelio or any of its ingredients
Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.

Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.

The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

Please see full Prescribing Information for Defitelio and visit www.Defitelio.com for additional information.

On November 28, 2018 Cold Genesys, Inc. reported that it has entered into a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate the combination of Cold Genesys’ lead oncolytic immunotherapy candidate CG0070 with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), in a Phase 2 clinical study (Press release, Cold Genesys, NOV 28, 2018, View Source [SID1234531682]).

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The trial is planned to evaluate the preliminary safety and efficacy of CG0070 plus KEYTRUDA in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), an unmet medical need, as no treatment for this indication has been approved by the FDA in approximately 20 years.

CG0070, an investigational oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway, which is present in many cancers. Several CG0070 clinical studies including a completed Phase 2 study (BOND2) have demonstrated a favorable safety profile and encouraging efficacy in patients with NMIBC following BCG failure.

"We are delighted to be collaborating with Merck on this innovative combination approach," said Arthur Kuan, CEO of Cold Genesys. "CG0070, which has demonstrated clinical safety and efficacy in over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with KEYTRUDA, which also has demonstrated single agent activity in the indication."

Cold Genesys will sponsor the study. Additional details of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CG0070

CG0070, a selectively replicative oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective Rb pathway. CG0070 was designed to work in two complementary ways. First, it replicates inside the tumor’s cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, which can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells. In advanced clinical studies, CG0070 has been shown to be a safe and efficacious agent in NMIBC following BCG failure. The scientific rationale and clinical results to date of CG0070 make it a promising agent to be developed for a variety of solid tumor types to be used alone or in combination with immune checkpoint modulators.