On October 12, 2015 Double Bond Pharmaceutical AB reported that it has entered into an agreement for the acquisition of the global rights for Temodex, a locally acting formulation of the established antineoplastic drug temozolomide, from the Research Institute of Physical and Chemical Problems (RI PCP) in Belarus, excluding the Eurasian Economic Union (Russia, Belarus, Kazakhstan, the Republic of Armenia, the Kyrgyz Republic), and Ukraine (Press release, Double Bond Pharmaceutical, OCT 12, 2015, View Source;a-locally-acting-brain-tumor-therapy-based-on-temozo,c9845990 [SID:1234508038]).

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Temozolomide is currently approved in Europa and USA as a first-line treatment for glioblastoma multiforme and as a second-line treatment for astrocytoma. Temodex, which is a locally acting form of temozolomide, was developed by the RI PCP and has successfully been studied clinically. Temodex was registered as a first-line treatment of glioblastoma multiforme in Belarus 2014. Glioblastoma multiforme, also known as glioblastoma and grade IV astrocytoma, is the most common and most aggressive malignant form of primary brain tumor.

"We are very pleased to further reinforce our commitment to oncology products and to add a new superior drug delivery candidate to our innovative portfolio. This acquisition is transformational for our company since DBP is taking a giant step forward from a preclinical-stage company to a clinical- and marketing-stage pharmaceutical company. It is a game changer for our commitment to build a leading independent pharmaceutical company that delivers value to our shareholders," says Igor Lokot, CEO of DBP. "Our vision is to develop therapies that improve the current standards of care and meets the urgent need for innovative and efficient drugs for patients suffering from glioblastoma."

DBP will be responsible for the development and regulatory and commercialization activities for Temodex worldwide excluding Eurasian Economic Union and Ukraine. Under the terms of the agreement, the RI PCP is eligible to receive one-digit tiered royalties on net sales.

About Temozolomide
Temozolomide is an oral chemotherapy drug which is considered to be a prodrug and also an imidazotetrazine derivative of the alkylating agent dacarbazine. Temozolomide is used as a treatment of several brain cancer forms, e.g., as a second-line treatment for astrocytoma and as a first-line treatment for glioblastoma multiforme. The therapeutic benefit of temozolomide is due to its ability to alkylate/methylate DNA. This alkylation/methylation destroys the DNA and triggers the death of the tumor cells. Temozolomide was developed by Malcolm Stevens and his team at Aston University in Birmingham in UK and has been available in the US since year 1999, and in other countries since year 2000.

About Temodex
Temodex, which is a locally acting form of temozolomide, was developed by the RI PCP in Minsk in Belarus and has successfully been clinically assessed. Temodex is registered as a first line treatment of glioblastoma multiforme in Belarus since 2014.

On October 12, 2015 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported the Company’s oncology drug candidate, CF102, has been granted Orphan Drug Designation by the European Medicines Agency (EMA) for the indication of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, OCT 12, 2015, View Source [SID1234529377]).

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CF102 will benefit from protocol assistance and a 10-year market exclusivity following market authorization in the 28 European Union (EU) Member states, as well as 3 additional European Economic Area (EEA) countries.

"The EMA’s Orphan Drug designation for CF102 is the latest in a series of catalysts that we believe are accelerating the clinical development path of our liver cancer drug towards market approval. As we actively recruit patients in our Phase II study of CF102 in Europe, we are pleased the EMA will support CF102 through protocol assistance and post-authorization market exclusivity," stated Can-Fite CEO Dr. Pnina Fishman.

In the U.S., CF102 has already received Fast Track Designation as a second line for the treatment of HCC of patients who have previously received Nexavar (sorafenib) and Orphan Drug Designation for the treatment of HCC. Israel’s Ministry of Health has also approved CF102 for Compassionate Use for HCC.

Can-Fite is conducting a Phase II study with CF102 in patients with advanced HCC in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar annual sales, as reported by Bayer, were €773 million in 2014.

About CF102

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

On October 11, 2015 Eli Lilly and Company (NYSE:LLY) and Innovent Biologics, Inc. (Innovent) reported an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company (Press release, Eli Lilly, OCT 11, 2015, View Source [SID:1234507692]).

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Below are details of the expanded agreement:

The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China.
Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed.

Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent.

"We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Lilly. "We are pleased to be expanding our collaboration with Innovent to further the development of potential therapies for those fighting cancer in China and around the world."

Michael Yu, Ph.D., co-founder, president and CEO of Innovent, stated, "We are honored that Lilly is so quickly expanding our relationship and that Lilly is trusting Innovent to develop and manufacture their newly created bispecific antibodies for China. We are excited to be at the forefront of immuno-oncology drug development and to benefit from Lilly’s deep experience in bispecific antibodies."

On October 9, 2015 Varian Medical Systems (NYSE:VAR) reported that its ARIA oncology information system has been certified as a Complete Electronic Health Record (EHR). As a result, hospitals and clinics can use ARIA to qualify for financial incentives from the Medicare and Medicaid programs when they demonstrate meaningful use of the technology (Press release, Varian Medical Systems, OCT 9, 2015, View Source [SID:1234507685]).

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"Varian is committed to the creation of digital tools that connect the entire oncology community, and enable coordinated care," said Sukhveer Singh, vice president of Varian’s Oncology Continuum Solutions group. "The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up. This certification means that our customers in the U.S. can continue to use ARIA to attest for the Meaningful Use 2014 measures, and thereby qualify for incentive payments from the federal government."

ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology.

The ARIA oncology information system (version 13.6 MR1), coupled with the Equicare Health Patient Portal for providing patients with secure web-based access to important portions of their medical records, were certified together to meet the federal requirements for Complete Ambulatory EHR.

Additional Information

The ARIA system for both medical and radiation oncology (version 13.6 MR1) was tested and certified in accordance with applicable certification criteria adopted by the U.S. Department of Health and Human Services. The software is compliant with the Office of National Coordinator (ONC) 2014 Edition criteria. ARIA received certification for Complete EHR from the Drummond Group, an ONC Authorized Certification Body. The ONC 2014 Edition criteria support both Stage 1 and Stage 2 meaningful use measures required to qualify eligible professionals for Medicare and Medicaid HIT incentive payments. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.

ARIA version 13.6 MR1 was certified on September 17, 2015. Certified ID numbers are 0917201526316 (for radiation oncology) and 0917201526306 (for medical oncology). The modules tested were: 170.314 (a)(115); (b)(15, 7); (c)(13); (d)(18); (e)(13); (f)(13); (g)(24). Clinical Quality Measures tested were: 2v3; 50v2; 68v3; 69v2; 124v2; 125v2; 129v3; 130v2; 138v2; 139v2; 140v2; 141v3; 154v2; 156v2; 157v2; 165v2.

Price Transparency

These certified products generally involve one-time license fees plus some ongoing costs:

ARIA Disease Management, a one-time initial license fee and ongoing Software Support Agreement (SSA) fees.
Equicare Health Solutions Active Patient Portal, a one-time initial license fee and ongoing SSA fees.
ePrescribing, a one-time initial license fee and ongoing SSA fees.
Interfaces: In and Outbound Laboratory, Immunization, Syndromic Health, a one-time initial license fee/interface and ongoing SSA fees.
DIRECT, a one-time initial license fee and ongoing service fees.

On October 9, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, treported the successful completion of Cohort 7 of its Phase Ib clinical trial evaluating the toxicity of its lead compound, Liposomal Grb-2, combined with low-dose cytarabine (LDAC) chemotherapy in patients with advanced Acute Myeloid Leukemia (AML) (Filing, 8-K, Bio-Path Holdings, OCT 9, 2015, View Source [SID:1234507687]). Bio-Path has opened enrollment into Cohort 8, which will complete the Company’s Phase Ib study of Liposomal Grb-2.

Three patients were evaluated in Cohort 7, which was the first cohort of the Company’s Phase Ib trial to evaluate the toxicity of Liposomal Grb-2 as a combination therapy. Patients were treated twice a week for four weeks with 60 mg/m2 of Liposomal Grb-2, for a total of eight doses in combination with the standard regimen of LDAC. Results were consistent with previous cohorts, showing Liposomal Grb-2 to be safe and well tolerated.

Furthermore, one patient achieved complete remission during treatment. A second patient demonstrated improvement in bone marrow blasts at the end of the first treatment cycle and is continuing Liposomal Grb-2 treatment as part of an additional treatment cycle. The third evaluable patient completed the treatment cycle, but did not show improvement. One patient ended the study early due to disease progression, and therefore was not evaluated in this cohort.

"I am highly encouraged to see that a patient suffering from advanced AML who was treated with Liposomal Grb-2 has achieved complete remission, and that another patient is continuing to improve," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "Complete remission in a patient with refractory and treatment-resistant AML is an exciting milestone for Bio-Path and blood cancer patients, suggesting that Liposomal Grb-2 might have the potential to improve survival rates in combination with frontline chemotherapy. We anticipate that these positive results will support rapid enrollment into Cohort 8, and look forward to continuing the development of Liposomal Grb-2."

Bio-Path has opened Cohort 8 for patients to be treated with 90 mg/m2 of Liposomal Grb-2, in combination with frontline LDAC. Upon successfully completing the evaluation of three patients in Cohort 8, the Company will finalize the Phase Ib clinical study.

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