10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

CytRx has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, CytRx, MAR 9, 2015, View Source [SID1234502229]).

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Kinex Pharmaceuticals Licenses Patents from Hong Kong Polytechnic University

On February 13, 2015 Kinex Pharmaceuticals reported the exclusive licensing of global rights of three patents from The Hong Kong Polytechnic University and McGill University (Press release, Athenex, MAR 9, 2015, View Source [SID1234517497]). These three patents covered the inventions by Professor Larry Chow and Professor William Chan including novel new chemical compounds that have nanomolar potency against a molecular target named Breast Cancer Resistance Protein (BCRP). BCRP is a protein pump known to pump drugs, including anticancer drugs, from cancer cells that can lead to drug resistance; and also to pump drugs back into gastrointestinal tract, which prevent some useful drugs to be delivered to their target.

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The development of this technology, if successful, will expand the current Kinex oral drug absorption development platform. That platform currently includes the inhibition of P-glycoprotein that Kinex licensed from Hanmi in 2011. The lead molecule, HM30181A, has been shown in clinical studies to enhance the absorption of anticancer drugs including paclitaxel and irinotecan into orally available drugs. The lead program, Oraxol (an oral form of paclitaxel), has demonstrated clinical efficacy and an excellent safety profile in patient studies. Kinex is also actively developing other proprietary oral drug delivery platforms. The addition of another oral absorption delivery technology platform will further strengthen Kinex’s arsenal of converting greater classes of intravenous drugs into oral versions.

The terms of this exclusive license include upfront payments, milestones and royalties. Kinex is also committing to support research programs in Professor Larry Chow’s laboratory to further develop this platform collaboratively with Kinex.

Johnson YN Lau, MBBS, MD, FRCP, Chairman and CEO of Kinex Pharmaceuticals, stated "The research of Professor Larry Chow complements Kinex’s drug development efforts. Kinex is a leader in the development of proprietary oral drug formulation and dosing for some of the important anticancer drugs including paclitaxel and irinotecan which currently have to be given intravenously. Oral versions of these drugs can be more efficacious and have fewer side effects for the patients. The discovery of lead molecules against another target such as BCRP that can enhance oral drug absorption by Professor Larry Chow and William Chan, if successfully developed clinically, will add to the arsenal of tools for Kinex. We are excited to collaborate with Professor Larry Chow to further develop this drug delivery platform and to convert more current intravenous drugs into oral form."

Flint Besecker, COO of Kinex, said, "We have learned in the clinic that converting existing intravenous drugs into oral forms opens the door to a wide array of proprietary formulation and titrated patient dosing regimens that are not possible through IV delivery systems. Oral forms of dosing allow the patients to be exposed over a longer period of time to the active pharmaceutical ingredients with less adverse side effects. This drug development strategy has less inherent risks and we are excited of the possibilities to make a difference in helping more patients. Such an effort, if successful, will have the potential to impact healthcare delivery globally and substantially."

Larry Chow, PhD, Professor and Associate Head of the Department of Applied Biology and Chemical Technology, commented, "I was impressed by Kinex in their ability to work with Hanmi Pharmaceuticals to advance the research program using a P-glycoprotein inhibitor to enhance the oral absorption of important drugs like paclitaxel and irinotecan and demonstrated its clinical utility. We are delighted that they will partner with us to help optimize our lead compound into a potentially useful molecule in the clinic for other drugs that are not absorbed orally because of this biologic pump system. Working with this wonderful group of industry veterans will allow us to tap into their expertise and to develop this platform further. I am excited with this collaboration."

Nick Yang, Executive Vice President of The Hong Kong Polytechnic University, stated, "To be able to establish successful collaborations between academia and industry is the mission of our University in transferring novel discoveries into useful applications that can help the community and serve the society. We are confident that the collaboration between PolyU and Kinex will open a new chapter for cancer drug development, bringing new hope to cancer patients globally and taking us one step closer to a revolution in cancer treatments."

Hanmi Pharmaceuticals to Assign the Rights of the Indian Territory to Kinex as Part of the Orascovery Program Strategic Plan

On March 9, 2015 Kinex Pharmaceuticals and Hanmi Pharmaceutical Co., Ltd. reported the execution of an agreement for Kinex Pharmaceuticals to lead the development of the Orascovery program in India (Press release, Athenex, MAR 9, 2015, View Source [SID1234517496]). The addition of this territory is part of the strategic plan to support Kinex and Hanmi’s joint effort to execute a global regulatory strategy. This also strengthens the existing agreement forged with Hanmi in December of 2011. With this agreement, Hanmi has granted to Kinex Pharmaceuticals the rights to develop and commercialize all products derived from the Orascovery program for all indications globally apart from Korea and Japan.

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Kinex Pharmaceuticals will assume all development responsibility in the licensed territories. ZenRx has joined the effort to develop Oraxol and Oratecan in the New Zealand and Australia territories, and PharmaEssentia of Taiwan has joined the effort to develop Oraxol and Oratecan in Taiwan and Singapore.

Dr. Gwan Sun Lee, Chief Executive Officer of Hanmi Pharmaceutical stated: "Kinex is a faithful partner who has been successfully progressing development of the Orascovery program. We are pleased to continue to work closely with Kinex and as we work together to bring more treatment options to patients"

Mr. Flint Besecker, Chief Operating Officer and Board Member of Kinex Pharmaceuticals, commented: "Hanmi has been an excellent partner. The assignment of the Indian Territory fills a remaining gap in our execution of the overall business strategy to develop these products globally. The companies’ well-coordinated networks of key opinion leaders and development sites have been instrumental in advancing our programs and helped facilitate productive discussions with different regulatory authorities. Kinex is also delighted to note that the preclinical development of the oral version of Docetaxel is also advancing nicely with support from the Innovation and Technology Commission (ITC) of the Government of the Hong Kong Special Administrative Region* and the support of the Department of Applied Biology and Chemical Technology of the Hong Kong Polytechnic University."

Spectrum Pharmaceuticals Announces FDA’s Acceptance of NDA Filing for Captisol-Enabled™ (Propylene Glycol-Free) Melphalan

On March 9, 2015 Spectrum Pharmaceuticals reported that its New Drug Application (NDA) for Captisol-Enabled Melphalan (CE-Melphalan), has been accepted by the U.S. Food and Drug Administration (FDA) (Press release, Spectrum Pharmaceuticals, MAR 9, 2015, View Source [SID:1234502226]). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 23, 2015 for the CE-Melphalan NDA, which is 10 months from the filing date. Spectrum is seeking FDA approval for its use as a high-dose conditioning treatment prior to autologous hematopoietic (progenitor) stem cell transplantation (AHCT) in patients with multiple myeloma (MM), an orphan drug designation. Spectrum is also seeking approval for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

“We are excited the CE-Melphalan filing has been accepted by the FDA, representing another important company milestone,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “CE-Melphalan met all pivotal trial endpoints, and we expect to launch this drug if approved, using our existing sales force towards the end of the year. The drug’s improved solubility and stability should make it an attractive treatment option for both transplant conditioning and the palliative treatment of patients with MM. Eliminating the need for propylene glycol in the preparation of CE-Melphalan eliminates the risk of the toxicities associated with this excipient. In addition, CE-Melphalan’s increased stability simplifies the logistics for pharmacies and nursing staff, and is anticipated to allow for longer infusion times which may permit the administration of higher dose intensities. We anticipate these characteristics of CE-Melphalan will facilitate rapid adoption. We look forward to bringing this drug to market and providing additional treatment options to patients suffering with cancer.”

The Phase 2 pivotal trial evaluating CE-Melphalan was a multi-center trial evaluating safety and efficacy. The primary objective of the study was to determine the overall safety and toxicity profile in MM patients receiving 200 mg/m2 of CE-Melphalan as myeloablative therapy prior to AHCT. The secondary objectives evaluated the efficacy of CE-Melphalan in this patient population as measured by Multiple Myeloma Response Rate (according to International Myeloma Working Group [IMWG] criteria), and the rates of myeloablation and engraftment. Study results support the safety and efficacy of high-dose CE-Melphalan as a high-dose conditioning treatment prior to AHCT in patients with MM. CE-Melphalan led to successful myeloablation and subsequent engraftment in all (100%) of the MM patients studied with no mortality or unexpected transplant-related toxicity. Overall, 95% of subjects (n=61) responded to high dose CE-Melphalan, and 67% VGPR or better responses were achieved in the subgroup of high risk patients (15%). There were no deaths by Day 100, and the most common Grade 3 and 4 toxicities were the expected hematologic events (neutropenia, leukopenia, lymphopenia, thrombocytopenia and anemia). The most frequent non-hematologic adverse events included diarrhea, nausea, and fatigue. Importantly, the incidence of severe mucositis was low (Grade 3/4; 10%).

Spectrum Pharmaceuticals gained global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013. Spectrum assumed the responsibility for the pivotal clinical trial and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.

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

Generex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, Generex, MAR 6, 2015, View Source [SID1234502223]).

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