On December 17, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) and Dana-Farber Cancer Institute reported the publication of results from the multicenter Phase 1/1b trial of umbralisib (TGR-1202), TG Therapeutics’ novel once-daily PI3K delta inhibitor, in combination with ibrutinib, the oral Bruton’s tyrosine kinase (BTK) inhibitor, in Lancet Haematology (Press release, TG Therapeutics, DEC 17, 2018, View Source [SID1234532247]). This investigator-initiated trial was conducted at Dana-Farber Cancer Institute and four additional academic and community sites across the USA in collaboration with the Leukemia and Lymphoma Society Blood Cancer Research Partnership with funding by TG Therapeutics. The publication includes safety and efficacy information from a total of 42 relapsed or refractory patients, 21 with chronic lymphocytic leukemia (CLL) and 21 with mantle cell lymphoma (MCL).

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In this study, the combination of umbralisib and ibrutinib was well tolerated and consistent with the additive toxicity profile of the two drugs individually. No dose-limiting toxicities were observed, and the maximum-tolerated dose of umbralisib when combined with ibrutinib was not reached. The recommended phase 2 dose of umbralisib when given in combination with ibrutinib was 800 mg once daily. Importantly, serious immune-mediated toxicities were not observed with this combination, as had previously been reported with combinations of different agents targeting this pathway, with only one case of transient Grade 3 transaminitis and no Grade 3/4 colitis or pneumonitis. The combination of umbralisib and ibrutinib was also clinically active, with 90% of relapsed/refractory CLL patients achieving an overall response (n=19), of which 62% (n=13) achieved a partial response or partial response with lymphocytosis, and 29% (n=6) achieved a complete response. Of the 21 patients treated with MCL, 67% (n=14) achieved an overall response, of which 48% (n=10) achieved a partial response and 19% (n=4) achieved a complete response.

These data are described further in the manuscript entitled, "Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicenter phase 1–1b study," which was published today in Lancet Haematology. The online version of the article can be accessed at http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30196-0/fulltext.

"Our study demonstrates for the first time that it is feasible to combine two agents targeting B cell receptor pathway kinases in patients with B cell malignancies," said Matthew Davids, MD, MMSc, Associate Director of the Center for Chronic Lymphocytic Leukemia at Dana-Farber. Dr. Davids continued, "We are particularly encouraged by the depth of response in the CLL patients, which compares favorably to historical data for ibrutinib monotherapy in this relapsed population. Our data support further exploration of dual BCR pathway blockade in CLL and other B cell malignancies."

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated "We want to thank Dr. Davids and the team at Dana-Farber, and most importantly the patients who participated in this trial. We are excited to publish the first ever data evaluating the all oral combination of a PI3K delta inhibitor with a BTK inhibitor and believe this paper further highlights the favorable safety profile and combinability of umbralisib as compared to prior generation PI3k deltas. We believe these data support our plans to develop combinations utilizing umbralisib plus our BTK inhibitor, TG-1701, which has already demonstrated activity in patients in early clinical studies."

On December 17, 2018 Daiichi Sankyo Company, Limited ("Daiichi Sankyo") and AnHeart Therapeutics Inc. ("AnHeart Therapeutics") reported they have entered into a worldwide exclusive license agreement ("Agreement") for DS-6051, Daiichi Sankyo’s selective ROS1/NTRK inhibitor, currently in phase 1 development in the United States and Japan (Press release, Daiichi Sankyo, DEC 17, 2018, View Source [SID1234532114]).

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Under the terms of the agreement, Daiichi Sankyo grants AnHeart Therapeutics worldwide exclusive rights for the development, manufacturing and commercialization of DS-6051. While Daiichi Sankyo and AnHeart Therapeutics will collaborate to continue two ongoing phase 1 studies, AnHeart Therapeutics will be responsible for further development of DS-6051 worldwide. Daiichi Sankyo will receive an upfront payment and is eligible for clinical, regulatory and sales milestone payments, as well as royalties on worldwide net sales of DS-6051. Financial terms of the agreement are not disclosed.

"We continue to look for innovative ways to maximize the potential of promising compounds in our oncology pipeline in order to deliver on our mission of transforming science into value for patients with cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We are confident that AnHeart Theraeputics will use the resources necessary to deliver a fast-to-market strategy to potentially bring this novel ROS1/NTRK inhibitor to patients as quickly as possible."

"We thank Daiichi Sankyo for its trust in AnHeart Therapeutics and its continued support in further developing the DS-6051 asset worldwide. DS-6051 is currently being studied in two phase 1studies for cancers bearing ROS1 or NTRK fusion mutations, and is a leading asset in our pipeline," commented Junyuan Wang, PhD, Chief Executive Officer, AnHeart Therapeutics. "It is our priority to move DS-6051 through the global regulatory pathways with a fast-to-market approach. We will communicate with regulatory agencies to initiate multiple global phase 2 trials of DS-6051 immediately after the transfer of clinical development responsibilities is completed."

About DS-6051

DS-6051 is an oral, selective small molecule ROS1/NTRK inhibitor currently being evaluated in two phase 1 clinical studies in patients with solid tumors harboring either a ROS1 or NTRK fusion gene and neuroendocrine tumors in the U.S. and Japan. Preliminary safety and efficacy data of DS-6051 from the first part of the U.S.-based phase 1/1b study were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.1

On December 17, 2018 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the second fiscal quarter ended October 31, 2018 (Press release, Champions Oncology, DEC 17, 2018, View Source [SID1234532113]).

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Second Quarter and Recent Business Highlights:

Record quarterly revenue of $6.7 million, an increase of 28.6% year-over-year

Reported income from operations of $514,000, excluding stock-based compensation and depreciation

Signed lease for new lab space for flow cytometry and ex-vivo product launches•
Reiterated forecast of at least 20% revenue growth in fiscal 2019 and sustained, quarterly operational profitability

Ronnie Morris, CEO of Champions, commented, "As we expected, our revenue growth continued in the second quarter with year-over-year growth above 28% and putting us on pace to achieve our previously stated guidance of at least 20% revenue growth for our fiscal year 2019."

Morris continued, "We are moving forward with plans to expand beyond our core PDX offering to include our ex-vivo platform and clinical flow cytometry services. We look to leverage our existing Pharma relationships, adding to our product line and offering a more robust suite of services."

David Miller, CFO of Champions added, "We are excited to hit another milestone of record quarterly revenue and reporting consecutive, profitable quarters. The anticipated launch of our new products will help continue our revenue growth as we look beyond fiscal year 2019."

Second Fiscal Quarter Financial Results

For the second quarter of fiscal 2019, revenue increased 28.6% to $6.7 million compared to $5.2 million for the second quarter of fiscal 2018. Total operating expenses for the second quarter of fiscal 2019 were $6.4 million compared to $5.3 million for the second quarter of fiscal 2018, an increase of $1.1 million or 21.7%.

Exhibit 99.1

For the second quarter of fiscal 2019, Champions reported income from operations of $275,000, including $88,000 in stock-based compensation and $151,000 in depreciation expenses, an improvement of $345,000 or 492.9% compared to the loss from operations of $70,000, inclusive of $148,000 in stock-based compensation and $90,000 depreciation expenses, in the second quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported income from operations of $514,000 for the second quarter of fiscal 2019 compared to an income from operations, excluding stock-based compensation and depreciation, of $168,000 in the second quarter of fiscal 2018 an improvement of $346,000 or 206.0%.

Cost of oncology solutions was $3.5 million for the three months ended October 31, 2018, an increase of $798,000, or 30.1% compared to $2.7 million for the three months ended October 31, 2017. The increase in cost of sales was due to an increase in TOS studies and salary expense. For the three months ended October 31, 2018, gross margin was 48.4% compared to 49.0% for the three months ended October 31, 2017.

Research and development expense was $1.2 million for the three months ended October 31, 2018, an increase of $78,000, or 7.0%, compared to $1.1 million for the three months ended October 31, 2017. Sales and marketing expense for the three months ended October 31, 2018 was $740,000, an increase of $189,000, or 34.3%, compared to $551,000 for the three months ended October 31, 2017. The increase is mainly due to an increase in salary expenses as we expand our salesforce. General and administrative expense was $1.0 million for the three months ended October 31, 2018 compared to $954,000 for the three months ended October 31, 2017, an increase of $80,000 or 8.4%. The increase is mainly due to recruiting costs.

Net cash generated was $940,000 for the three months ended October 31, 2018 compared to $229,000 for the same period last year. The improvement in cash flow is primarily due to operational results.

The Company ended the quarter with $2.0 million of cash and reiterated its position that it does not need to raise capital to fund operations.

Year-to-Date Financial Results

For the first six months of fiscal 2019, revenue increased 26.2% to $12.9 million, as compared to $10.2 million for the first six months of fiscal 2018. For the first six months of fiscal 2019, total operating expenses increased 11.3% to $12.1 million, as compared to $10.9 million for the first six months of fiscal 2018.

For the first six months of fiscal 2019, Champions reported an income from operations of $757,000, which includes $171,000 in stock-based compensation and $269,000 in depreciation, an improvement of $1.4 million or 209.9%, compared to the loss from operations of $689,000, inclusive of $741,000 in stock-based compensation and $132,000 depreciation, for the first six months of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported operating income of $1.2 million for the first six months of fiscal 2019.

Net cash provided by operations was $400,000 for the first six months of fiscal 2019 compared to net cash used in operations of $1.7 million in 2018, an increase of $2.1 million or 123.8%. The increase in cash is primary the result of our revenue growth.

Exhibit 99.1

Cost of oncology solutions was $6.5 million for the first six months of fiscal 2019 compared to $5.3 million for the first six months of fiscal 2018, an increase of $1.2 million or 23.4%. The increase in cost of sales was due to an increase in TOS studies. Gross margin was 49.4% for the first six months of fiscal 2019 compared to 48.3% for the first six months of fiscal 2018. The increase in cost of sales was due to an increase in TOS studies. Gross margin varies based on timing differences between expense and revenue recognition.

Research and development expense was $2.3 million for the first six months of fiscal 2019 an increase of $49,000, or 2.2% compared to $2.2 million for the first six months of fiscal 2018. Sales and marketing expense for the first six months of fiscal 2019 was $1.3 million, an increase of $24,000, or 1.9% compared to $1.2 million for the first six months of fiscal 2018. The increase is mainly due to increase in salary expense. General and administrative expense was $2.1 million for the first six months of fiscal 2019, a decrease of $76,000 or (3.5%) compared to $2.2 million for the first six months of fiscal 2018. The decrease is primarily due to a reduction in stock-based compensation expense.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) 10 minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday, December 17, 2018 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to Non-GAAP net income (loss) for an explanation of the amounts excluded to arrive at Non-GAAP net income (loss) and related Non-GAAP earnings (loss) per share amounts for the six months ended October 31, 2018 and 2017. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and Non-GAAP earnings (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines Non-GAAP dilutive earnings (loss) per share amounts as Non-GAAP net earnings (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings (loss) and Non-GAAP diluted earnings (loss) per share may differ from similarly named measures used by others companies

On December 17, 2018 HedgePath Pharmaceuticals, Inc. (OTCQB:HPPI) reported that it has entered into a revised Supply and License Agreement (SLA) with its majority stockholder Mayne Pharma Ventures Pty Ltd (Mayne Pharma), an affiliate of Mayne Pharma Group Limited (ASX: MYX) (Press release, HedgePath Pharmaceuticals, DEC 17, 2018, View Source [SID1234532107]).

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Under the new SLA, Mayne Pharma will assume control of the regulatory and clinical development program for SUBA-Itraconazole for the treatment of basal cell carcinoma nevus syndrome (SUBA-Itraconazole BCCNS) in anticipation of conducting a global Phase 3 pivotal clinical trial based on results achieved in the Phase 2(b) trial conducted by HPPI in the U.S. Mayne Pharma will immediately assume responsibility for all future SUBA-Itraconazole BCCNS-related expenses.

In consideration of the transfer to Mayne Pharma of the SUBA-Itraconazole BCCNS clinical data and regulatory rights, HPPI will receive the following consideration:

a 9% royalty on future net sales of SUBA-Itraconazole BCCNS in the U.S. (subject to deductions for HPPI’s continuing access to certain third party patents).

$3 million of new funding in stages tied to the transfer of SUBA-Itraconazole BCCNS to Mayne Pharma. This funding, which is expected to be completed by mid-2019, will be non-dilutive since it is structured as a discounted advance on the future 9% royalties receivable by HPPI (although if SUBA-Itraconazole BCCNS is not approved in the U.S. by the end of 2023, Mayne Pharma may recapture such discounted advances in the form of common stock of HPPI at the then current market value of HPPI’s common stock).

In addition, if HPPI is able to secure $3 million in new funding from third parties by June 30, 2021, at HPPI’s election, Mayne Pharma will make additional royalty advances of up to $2 million on the same terms. This commitment by Mayne Pharma of an additional $2 million in funding may alternatively be satisfied if Mayne Pharma elects to participate in future equity financings of HPPI.

The SLA will continue in effect, and the exclusive field covered by the SLA has been focused to specifically comprise prostate, lung and certain other non-cancer proliferation disorders. Mayne Pharma will have the right to exploit SUBA-Itraconazole in all other

fields in the U.S., including BCCNS. Importantly, HPPI’s continued right to work on these indications will no longer be tied to the achievement of clinical or commercial target dates. HPPI is now working towards the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for SUBA-Itraconazole for the treatment of prostate cancer (SUBA-Itraconazole Prostate), with the goal of having that IND cleared, allowing HPPI to proceed to recruitment for initiating human trials.

In addition, Mayne Pharma will continue to provide quantities of SUBA-Itraconazole drug and placebo oral capsules for HPPI’s SUBA-Itraconazole Prostate clinical study, with an agreed amount to be provided without charge.

In addition, unlike under the previous SLA, Mayne Pharma has licensed to HPPI the right to use all pre-clinical or clinical trial or other data generated or owned by Mayne Pharma related to the current SUBA-Itraconazole formulation anywhere in the world for HPPI’s activities in the U.S. in a specified field under the new SLA.

In addition, Mayne Pharma has agreed that it will support a reverse stock split of HPPI’s common stock should HPPI request this in connection with HPPI’s exploration of an uplisting to a senior stock exchange and associated capital raise.

Finally, Mayne Pharma has agreed to amend the terms of its existing Series B Convertible Preferred Stock to remove Mayne Pharma’s future right to require HPPI to redeem such securities, which will allow HPPI to fully classify such preferred stock as equity on its balance sheet.

Additional details of the transaction will be available in a Current Report on Form 8-K to be filed by HPPI with the SEC.

This transaction arose out of a right of Mayne Pharma under the previous SLA to assume control of SUBA-Itraconazole BCCNS after December 31, 2018 for a 9% royalty on future net sales of SUBA-Itraconazole BCCNS in the U.S. if a New Drug Application (NDA) for SUBA-Itraconazole BCCNS was not accepted for filing by FDA by December 31, 2018. As previously announced, based on unforeseen requirements imposed by FDA in September 2018, HPPI determined that it would be unable to responsibly file the SUBA-Itraconazole BCCNS NDA by this deadline, and thus HPPI commenced negotiations with Mayne Pharma to transfer SUBA-Itraconazole BCCNS in advance of December 31, 2018 on negotiated terms beneficial to HPPI. During these negotiations, HPPI actively undertook activities aimed at filing the SUBA-Itraconazole BCCNS NDA within the timeframes required under the SLA, but ultimately concluded in its business judgment based on significant regulatory guidance that such a filing, even if it could be accomplished, would imperil the regulatory acceptance and viability of the SUBA-Itraconazole BCCNS asset to the detriment of HPPI’s shareholders. HPPI believes that Mayne Pharma’s indication that it plans to undertake a Phase 3 study of SUBA-Itraconazole BCCNS validates HPPI’s strategic conclusions related to the present transaction with Mayne Pharma.

The transaction was negotiated and approved on behalf of HPPI by a special committee of disinterested, independent members of HPPI’s Board of Directors.

Nicholas Virca, HPPI’s President and Chief Executive Officer, stated that "It has taken a considerable effort to reach these important agreements with our majority stockholder, Mayne Pharma, and we thank them for working with us to achieve this outcome. We believe, taking into consideration all of the facts and circumstances, that enabling Mayne Pharma to pursue SUBA -Itraconazole BCCNS on advantageous terms to HPPI gives us a fresh start as a research and development company, with $3 million of near term funding and the possibility of an additional $2 million, a less restrictive SLA with Mayne Pharma with no development targets or deadlines, and access to worldwide SUBA-Itraconazole data to support our future business plans."

"Moving forward, our 2019 focus is to seek a pre-IND meeting with FDA, with the goal of reaching agreement with FDA on the endpoints for initiating a clinical trial of SUBA-Itraconazole Prostate. We commissioned a market study which included interviews with key opinion leaders to help us target a potential therapy for over 27,000 men who have metastatic castrate resistant prostate cancer who are no longer responding to androgen deprivation therapy (also known as ADT). As with SUBA-Itraconazole BCCNS, we intend to follow the 505(b)(2) regulatory pathway to accelerate our clinical testing program for SUBA-Itraconazole Prostate. Our goal will be to have our IND for SUBA-Itraconazole Prostate cleared by FDA and to begin efforts in recruiting patients for the prostate clinical trial before the end of 2019" continued Mr. Virca.

"Beyond SUBA-Itraconazole, we are planning to work with other compounds for the treatment of cancer in an effort to expand our product candidate pipeline. As announced earlier this year, we hold a world-wide exclusive option from the University of Connecticut regarding its patented chemical analogues of itraconazole to treat cancerous and non-cancerous indications. These next generation formulations of itraconazole appear to have reduced off-target side effects while exhibiting improved pharmacokinetic properties and a reduced concern associated with the use of many other drugs that are contraindicated for patients receiving itraconazole. A preclinical testing program is now underway to assess the effectiveness of the lead compound in treating certain cancers via hedgehog pathway inhibition in a well-established mouse model. If the pre-clinical results prove to be encouraging, we would expect to exercise our option and to begin efforts to outsource manufacturing to produce cGMP product as part of a program to move into human testing in 2020" concluded Mr. Virca.

Scott Richards, Mayne Pharma’s Chief Executive Officer, stated "Mayne Pharma remains committed to supporting HPPI and its leadership to pursue the clinical development, registration and commercialization of SUBA-Itraconazole for the treatment of oncology indications in the U.S. The management of HPPI has successfully progressed SUBA-Itraconazole BCCNS through its first major clinical program. We believe out-licensing our SUBA-Itraconazole intellectual property in the U.S. in this focused field through the partnership with HPPI provides Mayne Pharma shareholders with a significant stake in potentially multiple novel cancer programs. We look forward to working with HPPI to further these development programs."

On December 17, 2018 Celgene Corporation (NASDAQ:CELG) reported ten programs selected for funding under its Celgene Cancer Care Links program, an initiative designed to support cancer healthcare capacity building in resource-constrained countries around the world (Press release, Celgene, DEC 17, 2018, View Source [SID1234532106]).

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The programs selected are expected to support established institutions partnering with in-country medical centers that provide essential cancer care services including awareness and education, prevention, diagnosis and care. The Celgene Cancer Care Links program is an initiative of Celgene Global Health, which focuses on healthcare challenges facing patients in developing parts of the world.

"Celgene Cancer Care Links is another program we have created to make a meaningful impact for patients and healthcare systems around the world," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene. "We are excited to announce the first round of grants through this initiative and wish these world-renowned organizations and institutions great success."

Recipients of Celgene Cancer Care Links grants include:

Program Title Organization Partner Institution
Standard of care for pediatric Kaposi Sarcoma in Lilongwe, Malawi Baylor College of Medicine, Texas Children’s Hospital, Houston, TX Baylor College of Medicine Children’s Foundation – Malawi
National cervical cancer prevention program in Haiti: scaling up a pilot project Basic Health International, New York, NY St. Luke’s Foundation/Carmelle Voltaire Women’s Center – Haiti
Risk-adapted treatment of pediatric Burkitt Lymphoma in sub-Saharan Africa Baylor College of Medicine, Texas Children’s Hospital, Houston, TX Baylor College of Medicine Children’s Foundation – Uganda
Point-of-care diagnostics for lymphoma Dana-Farber Cancer Institute, Brookline, MA La Nacional Contra el Cancer (INCAN) – Guatemala
Implementation of Tanzania’s National Cancer Treatment Guidelines at Ocean Road Cancer Institute University of California, San Francisco Foundation, San Francisco, CA Ocean Road Cancer Institute – Tanzania
Advancing pharmacy care for cancer patients in South Asia Vennue Foundation, Stamford, CT Healthcare centers providing cancer care in Bangladesh and Nepal
Implementing multidisciplinary cervical cancer care in Nepal American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Alexandria, VA Bhaktapur Cancer Hospital – Nepal
Improve diagnosis and treatment of cancer in children, adolescents and young adults in Ghana World Child Cancer, London, UK Korle Bu Teaching Hospital – Ghana
Optimizing adherence to standard therapy delivery in non-metastatic breast cancer patients in Botswana University of Pennsylvania, Philadelphia, PA Princess Marina Hospital – Botswana
Long-distance learning platform (ONCOENSINO) Brazilian Lymphoma and Leukemia Society (ABRALE), Sao Paulo, Brazil

"The programs we are supporting through Celgene Cancer Care Links address many important areas of cancer diagnosis and care," said Joe Camardo, M.D., Senior Vice President, Global Health and Corporate Affairs Medical Strategy at Celgene. "For patients in resource-constrained nations like these, programs addressing this area fill a vital need in healthcare capacity."