Bristol-Myers Squibb and The Leukemia & Lymphoma Society Announce Charitable Donation to Support Critical Routine Testing and Awareness for Chronic Myeloid Leukemia Patients

On August 4, 2015 Bristol-Myers Squibb Company (NYSE:BMY) reported a charitable donation to The Leukemia & Lymphoma Society (LLS) (Press release, Bristol-Myers Squibb, AUG 4, 2015, View Source [SID:1234506989]). The donation will provide financial assistance for chronic myeloid leukemia (CML) patients who need help paying for Polymerase Chain Reaction (PCR) testing, an important tool used in the diagnosis and monitoring of CML. The donation will also support LLS CML awareness activities focused on educating patients, caregivers and healthcare providers about the importance of continued monitoring with PCR testing.

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"Routine PCR testing is critical because oncologists rely on the results to determine their patients’ clinical status of early and ongoing response to CML treatment and to help detect when patients are potentially becoming resistant to treatment, which may allow for earlier intervention," said Louis J. DeGennaro, LLS’s president and CEO. "Research indicates that early response to treatment and careful monitoring correlate with better overall survival rates."

The PCR test is used both in the diagnosis of CML and to monitor for cancerous cells after treatment has begun. It is the most sensitive testing method available, with the ability to detect a single cancerous cell among one million healthy cells. Recommendations suggest that a CML patient should receive a PCR test every three months for the first three years after diagnosis, and every three to six months thereafter based on how well their treatment is working. The average cost of a PCR test is $345 and can be as high as $500 per test. The program will assist insured and uninsured patients with out-of-pocket costs for PCR testing. The donation will also fund national CML awareness activities that will be undertaken by LLS’s 56 chapters, as well as grassroots efforts through local networks of patients, volunteers and healthcare institutions.

"With the life expectancy of more CML patients increasing, the need for routine PCR testing is very important to ensure optimal treatment results," said Laura Bessen, MD, vice president, head of U.S. Medical, Bristol-Myers Squibb. "Bristol-Myers Squibb is committed to helping patients living with CML have access to this important test and to also help patients better understand why the testing is important for their long-term prognosis."

LLS will also partner with The Max Foundation, Cancer Support Community and the National CML Society to facilitate ongoing promotion and awareness about the PCR Financial Assistance and Awareness Program.

To find out more about the PCR Financial Assistance and Awareness Program or to apply, call LLS at (877) 614-9242 or visit www.LLS.org/PCR.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which the body produces an uncontrolled number of abnormal white blood cells. According to LLS, approximately 33,990 people in the United States are living with CML. An estimated 5,980 new cases of CML were diagnosed in 2014. CML occurs when pieces from two different chromosomes (chromosomes 9, 22) break off and attach to each other. The newly formed chromosome is commonly called the Philadelphia chromosome. The abnormal formation of this chromosome creates an unwanted gene, called BCR-ABL. This gene is responsible for the production of the BCR-ABL protein, which triggers the development of abnormal white bloods cells, leading to CML. There is no known cause for why this genetic change occurs.

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

(Filing, 10-Q, Portola Pharmaceuticals, AUG 4, 2015, View Source [SID:1234507023])

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6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On August 4, 2015 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported financial results for the second quarter ending June 30, 2015 (Filing, 6-K, Compugen, AUG 4, 2015, View Source [SID:1234506990]).

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Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "The use of our powerful predictive discovery infrastructure has given rise to a novel immune checkpoint based target portfolio, which we believe provides the basis for a next wave of immuno-oncology drugs. Furthermore, we believe that the data to date from our five highest priority checkpoint programs, in addition to our two partnered programs, indicate that these programs potentially address multiple cancer types and different modes of action."

Dr. Cohen-Dayag, continued, "Our highest priority programs include myeloid specific novel immune checkpoint candidates identified within the tumor microenvironment of multiple cancers. Although in recent years there has been growing recognition of the importance of myeloid cells in cancer immunology, this area still represents an unexplored frontier of cancer immunotherapy. Therefore, we believe our programs could have a significant impact upon the cancer immunology field."

Dr. Cohen-Dayag concluded, "We believe that our current portfolio of programs, supported by our broadly applicable predictive target discovery infrastructure, has the potential to result in a sustainable and growing pipeline of first-in-class product candidates sequentially reaching the clinic, both by internal development and through early stage collaborations. In this regard, we remain on target to meet our previously stated objective of having at least one IND relating to a Compugen-discovered checkpoint filed during the first half of 2017."

Revenues for the second quarter of 2015 and six months ending June 30, 2015 were $0.2 million and $0.7 million respectively, compared with $2.0 million and $4.1 million for the comparable periods in 2014. The decrease in revenues is attributable mainly to the milestone payment in the amount of $1.2 million received in the second quarter of 2014 and a reduction in the recognition of the non-refundable upfront payment for the second quarter of 2015 and six months ending June 30, 2015, both under the August 2013 collaboration and license agreement with Bayer.

Net loss for the second quarter of 2015 was $6.8 million, or $0.14 per diluted share, compared with a net loss of $2.3 million, or $0.07 per diluted share, for the comparable period in 2014. Net loss for the six months ending June 30, 2015 was $13.0 million, or $0.26 per diluted share, compared with a net loss of $4.2 million, or $0.09 per diluted share, for the comparable period in 2014. The significant increase in net loss for the comparable periods, largely relates to a decrease in revenues as noted above, and an increase in the Company’s discovery and development activities relating to its Pipeline Program candidates.

As of June 30, 2015, cash, cash related accounts, short-term and long-term bank deposits totaled $95.7 million with no debt compared with $108.4 million as of December 31, 2014. The Company previously estimated gross cash expenditures in 2015 to be in the range of $31 million to $33 million.

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

(Filing, 10-Q, Isis Pharmaceuticals, AUG 4, 2015, View Source [SID:1234507027])

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Delcath Announces Acceptance of Abstracts for Presentation at the European Association of Dermato Oncology Annual Congress

On August 4, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that two abstracts summarizing data from studies in Europe and the U.K. of treatment with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) will be presented at the upcoming European Association of Dermato Oncology (EADO) annual congress, which will be held in Marseille, France, October 28-31, 2015 (Press release, Delcath Systems, AUG 4, 2015, View Source;p=RssLanding&cat=news&id=2075366 [SID:1234506991]).

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The abstracts are:

Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, a study conducted at Leiden University Medical Center in the Netherlands.
Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percutaneous Hepatic Perfusion – A Single Centre Experience, a study conducted at Southampton University in the United Kingdom.