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Celator® Pharmaceuticals Receives FDA Fast Track Designation For CPX-351 For The Treatment Of Elderly Patients With Secondary Acute Myeloid Leukemia

On January 20, 2015 Celator Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary Acute Myeloid Leukemia (AML) (Press release Celator Pharmaceuticals, JAN 20, 2015, View Source [SID:1234501354]).

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The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation facilitates meetings with FDA to discuss all aspects of development to support approval. It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, a Fast Track designated product could be eligible for priority review if supported by clinical data at the time of NDA submission.

"We are pleased that FDA has granted Fast Track status for CPX-351 for the treatment of elderly patients with secondary AML," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Our ongoing Phase 3 study in these patients has completed enrollment, and we expect induction response rate data to be available in the second quarter of this year, and to have overall survival data, the primary endpoint of the study, in the first quarter of 2016. If our Phase 3 study, comparing CPX-351 to the current standard of care, is successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process."

BioInvent’s BI-1206 antibody to enter collaborative Phase I/II trial funded and conducted by Cancer Research UK, CRT and Leukaemia & Lymphoma Research

On January 20, 2015 BioInvent International (OMXS: BINV) reported an agreement with Cancer Research UK, Cancer Research Technology (CRT), the charity’s development and commercialisation arm, and Leukaemia & Lymphoma Research (LLR) to take its investigational drug, BI-1206, into a collaborative phase I/II trial for patients with chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL) (Press release, Cancer Research Technology, JAN 20, 2015, View Source [SID1234523213]).

The first in man study will be funded and conducted by Cancer Research UK, CRT and LLR. BioInvent has been granted the option to take up an exclusive license to the study data, subject to payment of milestones and royalties to Cancer Research Technology.

BI-1206 is a fully-human anti-CD32b antagonistic antibody that in addition to directly killing tumour cells is thought to work by maintaining CD20 antibodies on the cell membrane of cancer cells, preventing them from becoming resistant to the current state-of-the-art treatment, rituximab.

The antibody has shown promise both in combination with CD20 antibodies and as a single agent in chronic lymphocytic lymphoma (CLL) and other types of NHL, in an extensive package of preclinical studies carried out by Leukaemia & Lymphoma Research-funded scientists at the University of Southampton. The potential development opportunity for BI-1206 may extend well beyond NHL.

The open label Phase I/ll study will enroll between 50 and 60 patients who will receive either BI-1206 alone or BI-1206 in combination with rituximab. The study will primarily enroll CLL patients but smaller cohorts of patients with other types of NHL, such as mantle cell lymphoma, follicular lymphoma and diffuse large B-cell lymphoma, may also be recruited. The study is expected to commence in the second half of 2015.

Each year in the UK approximately 12,800 people are diagnosed with NHL and 3,200 people are diagnosed with CLL. In Europe and North America around 157,000 people are diagnosed with NHL yearly and approximately 35,000 people are diagnosed with CLL.*

Michael Oredsson, CEO of BioInvent, said: "We are very pleased that Cancer Research UK and Leukaemia & Lymphoma Research have chosen to conduct and fund the BI-1206 Phase I/ll trial. Cancer Research UK is one of the world’s leading cancer research charities with in-house clinical, regulatory and medical capabilities and an established network of clinical cancer centres and leading clinicians in the UK. This agreement provides BioInvent with an ideal resource to execute the first-in-man study for BI-1206 whilst preserving the commercial value in the project."

Professor Chris Bunce, Research Director at Leukaemia & Lymphoma Research, said "Monoclonal antibodies have boosted survival rates for many types of lymphoma and leukaemia in recent years, but patient responses remain varied. BI-1206 has shown great promise in reducing treatment resistance in the laboratory. Leukaemia & Lymphoma Research has funded research into this treatment at the University of Southampton since 2008 and we’re very excited that through this partnership patients could benefit from it soon."

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said "BI-1206 has performed well in preclinical studies making it an ideal candidate for our Clinical Development Partnerships program, which helps industry run trials of potential new cancer treatments that would otherwise never progress beyond the lab. There is a real need for new blood cancer drugs that help boost the effectiveness of conventional chemotherapy drugs, as many patients cannot tolerate or become resistant to these treatments over time. Consequently, we look forward to seeing the results of this trial."

BI-1206 will be developed under Cancer Research UK’s Clinical Development Partnerships (CDP) program, a joint initiative between Cancer Research UK’s Centre For Drug Development (CDD) and CRT, to develop promising anti-cancer agents, which pharmaceutical companies do not have the resources to progress through early phase clinical trials.

It is the first drug to be entered into a new partnership through which Cancer Research UK and Leukaemia & Lymphoma Research will be jointly funding early phase clinical trials for patients with blood cancers.

Cancer Research UK’s CDD will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with Leukaemia & Lymphoma Research providing the majority of the funding.

Valneva and BliNK Therapeutics confirm launch and funding of BliNK Biomedical

On January 20, 2015 European biotechnology company Valneva SE ("Valneva") and UK company BliNK Therapeutics Ltd ("BliNK Therapeutics") reported the closing of the transaction creating BliNK Biomedical SAS, a private company specialised in the discovery of innovative monoclonal antibodies as announced on December 11th, 2014 (Press release, Cancer Research Technology, JAN 20, 2015, View Source [SID1234523212]).

The new company is owned by Valneva, Kurma Biofund I (founding investor of BliNK Therapeutics), funds managed by Idinvest Partners, Cancer Research Technology (CRT) and BliNK Therapeutics’ founders.

BliNK Therapeutics’ technology has been developed by Facundo Batista, Head of the Lymphocyte Interaction Laboratory at Cancer Research UK’s London Research Institute.

CytRx Announces FDA’s Removal of Partial Clinical Hold for Aldoxorubicin Clinical Trials Permitting Immediate Enrollment of New Patients

On January 20, 2015 CytRx Corporation reported that the United States Food and Drug Administration (FDA) has removed the partial clinical hold on the Company’s aldoxorubicin clinical trials (Press release CytRx, JAN 20, 2015, View Source [SID:1234501356]). Enrollment and dosing of new patients is now permitted after study sites’ Institutional Review Boards (IRBs) approve the revised trial protocols.

“CytRx developed modified study parameters intended to avoid potential risks, while allowing the company to evaluate the therapeutic impact of aldoxorubicin for patients with soft tissue sarcoma, glioblastoma, Kaposi’s sarcoma, and small cell lung cancer, among other trials,” said Steven A. Kriegsman, Chairman and CEO of CytRx. “Our staff worked closely with the FDA Oncology Division to resolve all partial clinical hold issues as rapidly as possible. We expect enrollment and dosing in the ongoing clinical trials to be back underway soon.”

CytRx currently believes that enrollment rates and timelines for its trials will remain materially unchanged. The Company expects to complete enrollment in its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015 and unblind the clinical data by mid-2016. Subject to FDA approval, CytRx’s market launch of aldoxorubicin for second line soft tissue sarcoma is projected to commence in 2017.

Eleison Pharmaceuticals Partners with Intelgen (HK) Limited to Develop and Commercialize ILC for the China Market

On January 19, 2015 Eleison Pharmaceuticals, Inc. ("Eleison"), a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, reported a partnership with Intelgen (HK) Limited ("Intelgen") to develop and commercialize the lung cancer drug candidate ILC (Inhaled Lipid-complexed Cisplatin) for the Chinese market (Press release, Eleison Pharmaceuticals, JAN 19, 2015, View Source [SID1234517398]). Mr. Edwin Thomas, CEO of Eleison Pharmaceuticals commented, "We are highly pleased to have as a partner Intelgen, an emerging pharmaceutical company in China and ideally capable of developing and commercializing ILC." Ms. Lan Zou, President and CEO of Intelgen commented, "ILC is potentially an important new treatment for lung cancer, and we look forward to working with Eleison to develop ILC for the benefit of patients with few therapeutic options." Under the terms of the partnership agreement, Intelgen received exclusive marketing rights in China and will be responsible for marketing and distribution of ILC in the China market. Eleison and Intelgen will work cooperatively for the clinical development and regulatory approval of ILC in China. Eleison has received an up-front payment, and will receive royalties, milestone payments, and development support from Intelgen.