On October 25, 2017 LabCorp (or the "Company") (NYSE: LH) reported results for the third quarter ended September 30, 2017, and increased its 2017 guidance (Press release, LabCorp, OCT 25, 2017, View Source;p=RssLanding&cat=news&id=2310992 [SID1234521154]).

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"We delivered record results highlighted by outstanding growth in the quarter, as revenue increased by 10%, adjusted EPS increased by 9%, and continued strong cash flow resulted in an increase of our full year free cash flow guidance to roughly $1 billion," said David P. King, chairman and CEO. "The Diagnostics business had strong organic and total volume growth despite the adverse impact from multiple hurricanes, and the Drug Development business turned in a solid performance, highlighted by improved margins, robust net orders, increased book-to-bill, and the closing of the Chiltern acquisition. We continue to expand our capabilities, broaden our geographic and customer base, deliver innovative solutions that only LabCorp can offer, and position ourselves for growth in the years ahead."

Consolidated Results

Third Quarter Results

Net revenue for the quarter was $2.60 billion, an increase of 9.5% compared to $2.37 billion in the third quarter of 2016. The increase in net revenue was due to growth from acquisitions of 6.9%, organic growth (net revenue growth less revenue from acquisitions for the first twelve months after the close of each acquisition) of 2.3%, and the benefit from foreign currency translation of approximately 30 basis points. In addition, revenue growth was negatively impacted by approximately 0.7% due to multiple hurricanes during the quarter.

Operating income for the quarter was $341.3 million, or 13.1% of net revenue, compared to $324.0 million, or 13.7%, in the third quarter of 2016. The increase in operating income was primarily due to acquisitions, organic revenue growth, and the LaunchPad business process improvement initiative, partially offset by higher personnel costs. The decline in operating margin was primarily due to restructuring charges, special items, and amortization totaling $105.2 million in the quarter, compared to $80.0 million during the same period in 2016. Adjusted operating income (excluding amortization of $54.6 million, as well as restructuring charges and special items of $50.6 million) for the quarter was $446.5 million, or 17.2% of net revenue, compared to $404.0 million, or 17.0%, in the third quarter of 2016.

Net earnings in the quarter were $180.6 million, compared to $179.5 million in the third quarter of 2016. Diluted EPS were $1.74 in the quarter, an increase of 1.8% compared to $1.71 in the same period in 2016. Adjusted EPS (excluding amortization, restructuring charges and special items) were $2.46 in the quarter, an increase of 9.3% compared to $2.25 in the third quarter of 2016. The Company’s adjusted earnings in the quarter were reduced by approximately $0.09 per diluted share due to the impact from multiple hurricanes.

Operating cash flow for the quarter was $350.9 million, compared to $249.9 million in the third quarter of 2016. The increase in operating cash flow was primarily due to higher cash earnings and improved working capital management. Capital expenditures totaled $75.3 million, compared to $66.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $275.6 million, compared to $183.7 million in the third quarter of 2016.

At the end of the quarter, the Company’s cash balance and total debt were $409.3 million and $7.2 billion, respectively. During the quarter, the Company invested approximately $1.2 billion in acquisitions, and repurchased $42.1 million of stock representing approximately 0.3 million shares. The Company had $447.4 million of authorization remaining under its share repurchase program at the end of the quarter.

Year-To-Date Results

Net revenue was $7.50 billion, an increase of 6.4% over last year’s $7.05 billion. The increase in net revenue was due to growth from acquisitions of 4.4%, and organic growth of 2.3%, partially offset by the impact of foreign currency translation of approximately 20 basis points.

Operating income was $1,010.0 million, or 13.5% of net revenue, compared to $989.0 million, or 14.0%, in the first nine months of 2016. The Company recorded restructuring charges and special items of $111.5 million in the first nine months of the year, compared to $82.7 million during the same period in 2016. The increase in operating income was primarily due to strong revenue growth and productivity, partially offset by higher personnel costs. The decline in operating margin was primarily due to higher amortization, restructuring charges and special items. Adjusted operating income (excluding amortization of $153.6 million, restructuring charges and special items) was $1.3 billion, or 17.0% of net revenue, compared to $1.2 billion, or 17.1%, in the first nine months of 2016.

Net earnings in the first nine months of 2017 were $561.4 million, or $5.40 per diluted share, compared to $547.7 million, or $5.25 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring charges and special items) were $7.14, an increase of 7.0% compared to $6.67 in the first nine months of 2016.

Operating cash flow was $895.4 million, compared to $727.0 million in the first nine months of 2016. The increase in operating cash flow was primarily due to higher cash earnings and lower working capital usage. Capital expenditures totaled $216.8 million, compared to $204.6 million in the first nine months of 2016. As a result, free cash flow (operating cash flow less capital expenditures) was $678.6 million, compared to $522.4 million in the first half of 2016.

***

The following segment results exclude amortization, restructuring charges, special items and unallocated corporate expenses.

Third Quarter Segment Results

LabCorp Diagnostics

Net revenue for the quarter was $1.84 billion, an increase of 9.9% over $1.67 billion in the third quarter of 2016. The increase in net revenue was driven by acquisitions, organic volume (measured by requisitions excluding those from acquisitions for the first twelve months after the close of each acquisition), price, mix, and the benefit from foreign currency translation of approximately 20 basis points. Total volume (measured by requisitions) increased by 7.3%, of which organic volume was 2.3% and acquisition volume was 5.1%. Volume was negatively impacted by approximately 1.0% due to multiple hurricanes during the quarter. Revenue per requisition increased by 2.4%.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $373.8 million, or 20.3% of net revenue, compared to $341.8 million, or 20.4%, in the third quarter of 2016. The increase in operating income was primarily due to strong revenue growth and LaunchPad savings. The 10 basis point decline in operating margin was due to the adverse impact from multiple hurricanes during the quarter. Excluding the impact from hurricanes, the operating margin would have increased 60 basis points over last year. During the quarter, the Company achieved its three-year goal to deliver $150 million in net LaunchPad savings.

Covance Drug Development

Net revenue for the quarter was $761.1 million, an increase of 8.6% over $701.1 million in the third quarter of 2016. The increase was primarily due to the acquisition of Chiltern, as well as organic growth and the benefit from foreign currency translation of approximately 60 basis points.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $108.9 million, or 14.3% of net revenue, compared to $95.5 million, or 13.6%, in the third quarter of 2016. The increase in operating income and margin were primarily due to the acquisition of Chiltern, organic revenue growth, cost synergies, and LaunchPad savings, partially offset by increased personnel costs. During the quarter, the Company achieved its three-year goal to deliver cost synergies of $100 million related to the acquisition of Covance. In addition, the Company remains on track to generate savings of approximately $20 million in 2017 (approximately $45 million on an annualized basis) from the expansion of the LaunchPad initiative to include Covance Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $3.82 billion and 1.33, respectively. Backlog at the end of the quarter was $6.84 billion, which includes backlog from the Chiltern acquisition of $1.0 billion. The Company expects approximately $2.7 billion of this backlog to convert into revenue in the next twelve months.

Outlook for 2017

The following guidance assumes foreign exchange rates effective as of September 30, 2017 for the remainder of the year, and includes capital allocation.

Net revenue growth of 8.0% to 8.5% over 2016 net revenue of $9.44 billion, which includes the negative impact from approximately 10 basis points of foreign currency translation. This is an increase over the prior guidance of 5.0% to 6.5%.
Net revenue growth in LabCorp Diagnostics of 8.5% to 9.0% over 2016 net revenue of $6.59 billion. This is an increase over the prior guidance of 7.0% to 8.0% primarily due to the consolidation of a joint venture related to the acquisition of PAML.
Net revenue growth in Covance Drug Development of 6.0% to 7.5% over 2016 net revenue of $2.84 billion, which includes the negative impact from approximately 10 basis points of foreign currency translation. This is an increase over the prior guidance of 1.0% to 3.0% due to the acquisition of Chiltern.
Adjusted EPS of $9.40 to $9.60, an increase of approximately 6% to 9% as compared to $8.83 in 2016. This is an improvement over the prior guidance of $9.30 to $9.65.
Free cash flow (operating cash flow less capital expenditures) of $970 million to $1,010 million, an increase of approximately 8% to 13% over the prior year. This is an increase over the prior guidance of $925 million to $975 million due to continued strong earnings and working capital management.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including Adjusted EPS, Adjusted Operating Income, Free Cash Flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing a Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available in the investor relations section of the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. Eastern Time and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 90788597. A telephone replay of the call will be available through November 8, 2017 and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 90788597. A live online broadcast of LabCorp’s quarterly conference call on October 25, 2017 will be available at View Source or at View Source beginning at 9:00 a.m. Eastern Time. This webcast will be archived and accessible through October 19, 2018.

On October 25, 2017 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer (Press release, Genentech, OCT 25, 2017, View Source [SID1234521248]).

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"About 80 percent of women with ovarian cancer are diagnosed in the advanced stages when the disease is difficult to treat and options are limited," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible."

This sBLA for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, is based on data from the pivotal Phase III GOG-0218 trial. In newly diagnosed advanced ovarian cancer, the first treatment a woman receives after surgery is known as front-line treatment. The FDA is expected to make a decision on approval by June 25, 2018.

This is part of our broader development program for Avastin in ovarian cancer. Avastin is currently approved for treating two different forms of advanced disease that recurred after platinum-based chemotherapy. In addition, Genentech is evaluating Avastin in combination with Tecentriq (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer in the Phase III IMagyn050 trial (NCT03038100).

About the GOG-0218 Study

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.64; 95% CI 0.54 – 0.77, p<0.0001). Secondary endpoints of the study included overall survival (OS) and objective response rate (ORR). Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications. The study was conducted by the Gynecologic Oncology Group (GOG) and their initial results were previously published in the New England Journal of Medicine.

About Ovarian Cancer

Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2017, nearly 22,000 women will be diagnosed with ovarian cancer in the U.S. and more than 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly, and/or frequent urination, are present, they can be associated with other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).

Avastin Indications:

Avastin is indicated for the first or second line treatment of patients with metastatic colorectal cancer in combination with intravenous 5 fluorouracil–based chemotherapy.
Avastin in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is indicated for the second line treatment of patients with metastatic colorectal cancer who have progressed on a first line Avastin-containing regimen. Avastin is not indicated for adjuvant treatment of colon cancer.
Avastin in combination with carboplatin and paclitaxel chemotherapy is indicated for first line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small cell lung cancer.
Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix.
Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments. Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (psOC).
BOXED WARNINGS and Additional Important Safety Information

People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:

Gastrointestinal (GI) perforation:

Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine.
In clinical trials, this event occurred in more people who received Avastin than in the comparison group (up to 3.2%).
In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.
Surgery and wound healing problems:

Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality.
Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15% for patients who received Avastin and 4% for patients who did not receive Avastin.
Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined.
Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.
Severe bleeding:

Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy.
Across cancer types, 0.4% to 6.9% of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.
Additional serious adverse events

In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group.

The formation of an abnormal passage in the body (GI and non-GI fistula formation) was seen in up to 2% of people in metastatic colorectal cancer and ovarian cancer patients. In a study of patients with cervical cancer, formation of an abnormal passage between the vagina and GI tract was seen in 8.3% of people.
Severe to life-threatening stroke or heart problems were seen in 2.6% of people.
Too much protein in the urine that led to kidney problems was seen in ≤1% of people.
Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included
Severe to life-threatening blood clots (VTE), up to 10.6%
Severe to life-threatening high blood pressure, which was seen in 5% to 18% of people
Nervous system and vision disturbances (Posterior Reversible Encephalopathy Syndrome), which was seen in less than 0.5% of people.
Infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3% of people, and severe reactions occurred in 0.2% of people.
Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children. Avastin should not be used in ovarian cancer patients who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
Patients who are pregnant, think they are pregnant, or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for six months following the last dose of Avastin. Avastin can cause fertility issues for women.

Women should be advised that breastfeeding while on Avastin may harm the baby and is therefore not recommended.

Common side effects that occurred in more than 10% of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis).

Across all trials, treatment with Avastin was permanently stopped in 8.4% to 21% of people because of side effects.

Report side effects to the FDA at (800) FDA-1088 or View Source . Report side effects to Genentech at (888) 835-2555.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit View Source .

On October 26, 2017 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) and TESARO, Inc. (“TESARO”) reported a three-year integrated drug discovery collaboration to discover and develop novel small molecule product candidates against an undisclosed immuno-oncology (IO) target (Press release, Evotec, OCT 25, 2017, View Source [SID1234521186]).

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Under the terms of the collaboration, Evotec will apply its integrated drug discovery platform, from lead discovery through nomination of a pre-clinical development candidate, to TESARO’s translational research pipeline to advance best-in-class oncology therapies. In particular, Evotec will leverage its industry leading structural biology platform to identify novel start points to progress into a full-blown drug discovery programme.

“TESARO is excited to work with Evotec to expand our discovery capabilities against immuno-oncology targets”, said Jeffrey Hanke, Ph.D., Executive Vice President, Research and Development, and Chief Scientific Officer of TESARO. “Evotec has a proven track record of enhancing its partners’ drug discovery efforts in oncology. We look forward to working with Evotec to accelerate the identification of new therapies to help patients facing cancer.”

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: “Oncology is one of Evotec’s core therapeutic areas of focus and we are pleased to enter into this exciting and innovative partnership with TESARO, a globally recognised oncology leader and one of the fastest growing biotech companies in the USA. This collaboration further demonstrates the value of our integrated research site in Toulouse and our world-leading structural biology group in Oxford. Using our integrated drug discovery platform, we are committed to helping TESARO drive innovation in this very important field of high-unmet medical need.”
No financial details of the collaboration were disclosed.

On October 25, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant (BMT) and for the targeting and killing of cancer cells reported that the Company has successfully activated fifteen clinical trial sites in the pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia) trial (Press release, Actinium Pharmaceuticals, OCT 25, 2017, View Source [SID1234521146]).

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The SIERRA trial is planned to enroll 150 patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above and will compare Iomab-B and a BMT to physician’s choice of salvage chemotherapy. The primary end point is durable complete remission (dCR) of at least 6 months. Iomab-B is intended to provide safer myeloablation of the bone marrow prior to a bone marrow transplant, thus providing a potentially curative treatment option for this patient population and for patients with other leukemias, lymphomas, myelomas and other blood disorders. The following medical institutions are clinical trial sites in the Iomab-B Phase 3 clinical trials:

Center Location
MD Anderson Cancer Center Houston, Texas
Memorial Sloan Kettering Cancer Center New York, New York
Mayo Clinic Rochester, Minnesota
Mayo Clinic Jacksonville, Florida
Washington University School of Medicine Saint Louis, Missouri
Yale Cancer Center New Haven, Connecticut
Baylor Charles A. Sammons Cancer Center Dallas, Texas
The University of Kansas Cancer Center Westwood, Kansas
Roswell Park Cancer Institute Buffalo, New York
University Hospitals Cleveland Medical Center Cleveland, Ohio
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
Penn State Hershey Cancer Institute Hershey, Pennsylvania
Loyola University Medical Center Maywood, Illinois
Banner MD Anderson Cancer Center Gilbert, Arizona
Fred Hutchinson Cancer Research Center Seattle, Washington
Dr. Mark Berger, Actinium’s Chief Medical Officer said, "I am delighted to be working with these world-renowned investigators and institutions in this important SIERRA trial for Iomab-B. Their interest and enthusiasm for Iomab-B further motivates my team as we work on this trial to bring Iomab-B to patients who could benefit from safer myeloablation prior to a bone marrow transplant. In many blood cancers and disorders a bone marrow transplant is the only potentially curative treatment option for patients and it is our goal to improve outcomes for these patients with Iomab-B by getting them to their transplant faster and with less complications than currently available myeloablative regimens allow. We are looking forward to adding additional clinical trial sites located in the U.S. and Canada to make this trial available to a greater range of patients and to expedite completion of the trial."

Actinium also announced that it will provide an update on the Iomab-B SIERRA trial by year end. The SIERRA trial will have three safety analyses by an independent Data Monitoring Committee when 25%, 50% and 75% patient enrollment has been reached. Also, two ad-hoc efficacy analyses may be requested by Actinium after 70 and/or 110 patients have engrafted and given enough time to achieve the primary endpoint of durable complete remission at six months post treatment.

Sandesh Seth, Actinium’s Chairman & CEO said, "Until this trial, Iomab-B had only been studied in a single center and Actinium is proud to have facilitated use of this important therapeutic option in most of the leading transplant centers in the U.S. via the SIERRA trial. These fifteen centers perform approximately a third of all AML related bone marrow transplants. Our ability to introduce Iomab-B in these centers bodes well for enrollment in the trial and also the commercial opportunity for Iomab-B as the top fifty centers account for approximately eighty percent of bone marrow transplants. There is no visible competition for Iomab-B from any drug or drug candidate that can provide safer myeloablation and enable improved outcomes of bone marrow transplant. Actinium intends to build on the clinical experience, infrastructure and supply chain capabilities that we have established thus far to complete the trial in accordance with prior guidance and, assuming a successful outcome, establish Iomab-B as the standard of care in providing safer myeloablation first in in AML and then in the other hematologic indications in which it has shown positive results."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

On October 25, 2017 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare diseases, reported that the American Association for Cancer Research (AACR) (Free AACR Whitepaper) has published Phase 1 data from an ongoing Phase 1/2 study of X4P-001-IO in combination with Inlyta (axitinib), Pfizer’s VEGFR kinase inhibitor (Press release, X4 Pharmaceuticals, OCT 25, 2017, View Source [SID1234521155]). Updated preliminary efficacy data along with safety and tolerability of the combination will be highlighted in a poster presentation at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 26-30 in Philadelphia, Pennsylvania.

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Details of the Poster Presentations on X4P-001-IO:
Poster Title: A Phase 1 dose finding study of X4P-001 (an oral CXCR4 inhibitor) and axitinib in patients with advanced renal cell carcinoma (RCC)
Author: Atkins, Michael
Session Category: Tumor Microenvironment
Session Date and Time: Sunday Oct 29, 2017 12:30 PM – 4:00 PM
Location: Hall E, Pennsylvania Convention Center
Permanent Abstract Number: B201

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule inhibitor of CXCR4 (C-X-C receptor type 4) that regulates the tumor microenvironment thereby enhancing endogenous anti-tumor responses. CXCR4 is a chemokine receptor that modulates immune function and angiogenesis through the trafficking of key immune cells such as T- cells, dendritic cells, and myeloid derived suppressor cells. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment.

About Renal Cell Carcinoma

Kidney cancer is among the ten most common cancers in both men and women with more than 60,000 new diagnoses each year in the United States.1 Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer, and advanced ccRCC accounts for approximately 20% of the patient population. Therapies for advanced ccRCC include immunotherapies, mammalian target of rapamycin (mTOR) kinase inhibitors, and angiogenesis inhibitors, such as vascular endothelial growth factor (VEGF) inhibitors.2 There continue to be unmet medical needs with advanced ccRCC because durable responses remain a serious clinical challenge for patients with advanced disease.