On Apr 7, 2015 Panther Biotechnology, Inc. ( OTC PINK : PBYA ), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic and autoimmune disorders reported that it has entered into a definitive agreement with privately held Faulk Pharmaceuticals, Inc. to acquire Faulk’s pharmaceutical technology assets (Press release, Panther Biotechnology, APR 7, 2015, View Source [SID1234517414]). The transaction will provide Panther Biotechnology with a proprietary, multinationally patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications.

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The lead development program is a ligand-drug conjugate, TRF-DOX, a combination of transferrin glycoproteins with Doxorubicin for targeted delivery to tumors with the reduction of serious side effects. Clinical results demonstrate significant improvement over Doxorubicin. In a randomized, double blind, controlled study of patients with advanced FIGO stage IV ovarian cancer, the addition of either TRF-DOX or Doxorubicin to conventional chemotherapy was compared. Treatment with TRF-DOX resulted in a statistically significant increase in survival over Doxorubicin in patients with drug resistant ovarian cancer. In a non-blinded study in patients with acute leukemia, TRF-DOX was dosed at 10% of the usual dose and demonstrated an 87% decline in cancer cells circulating in the blood and no extension of the disease to bone marrow in 100% of the patients. TRF-DOX also exhibited a complete response of both the primary tumor and metastatic lesions in a patient with angiosarcoma after having failed three months of standard chemotherapy. Panther plans to submit applications for a phase 2 study in ovarian cancer and a phase 1a / 1b study in lung cancer.

TRF-DOX leverages the targeting ability of the plasma protein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself. Cytotoxicity studies demonstrate that a dose reduction of ten to one hundred-fold kills all cancer cells in multiple indications. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.

Under the terms of the agreement, in exchange for substantially all the assets of Faulk Pharmaceuticals, Panther will issue shares of the common stock of Panther Biotechnology, Inc. in addition to a tiered royalty payment agreement based on the achievement of specified revenue milestones for any commercialized products based on the acquired technology. As part of the agreement, Panther will also gain access to a strong research and development network and a portfolio of domestic and international patents. The transaction is expected to close by the end of May.
"We are very excited to be acquiring Faulk Pharmaceutical’s technology, which we see as complementary to our efforts to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer," stated Evan Levine, Chief Executive Officer of Panther Biotechnology. "This acquisition is a continuation of our strategy to build out a robust pipeline with novel pharmaceutical technologies that improve the efficacy and tolerability of validated therapies."

"Panther’s expanded pipeline now includes both early and later stage drugs that address multi-billion dollar market opportunities for cancer and autoimmune diseases. The oncology assets under exploration include molecules targeting certain cancer stem cells," said Dr. Jayesh Mehta who is a Director of Panther and Professor of Medicine at the Northwestern University Feinberg School of Medicine, and heads the Hematopoietic Stem Cell Transplant Program of Northwestern Memorial Hospital.

"Our decision to join Panther has been driven both by our conviction in their ability to leverage our technology platform and also by the high value we see in the TRF-DOX program," stated Dr. W. Page Faulk, founder of Faulk Pharmaceuticals. "We look forward to taking an active role in advancing TRF-DOX into new clinical trials, in addition to furthering the development of the pipeline of drug candidates we created. We are very pleased to become part of a company that shares our commitment to improving the lives of patients suffering from cancer and other diseases with high unmet medical needs."

RestorGenex 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, 10-K, RestorGenex, APR 3, 2015, View Source [SID1234502920]).

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On April 2, 2015 Columbia Laboratories, Inc. (Nasdaq: CBRX) (the "Company"), reported that it will adopt Juniper Pharmaceuticals, Inc. as its new corporate brand (Press release, Juniper Pharmaceuticals, APR 2, 2015, View Source;p=irol-newsArticle&ID=2031852 [SID:1234510481]). The name change will become effective Friday, April 10, 2015, and the Company’s common stock will begin trading on the Nasdaq Stock Exchange under the new ticker symbol — "JNP" — on Monday, April 13, 2015. The Company will also unveil its new logo and launch its new website, www.juniperpharma.com, on April 13, 2015.

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"Adopting the Juniper Pharmaceuticals brand marks the next step in the Company’s return to developing specialty products in women’s health. We are committed to anticipating and addressing unmet medical needs and developing important therapeutics for patients," said Frank Condella, President and CEO.

The Company’s wholly owned subsidiary, Molecular Profiles Ltd. based in Nottingham, England, will also begin operating as Juniper Pharma Services on April 13, 2015.

"The single Juniper brand formalizes the synergies we have built across our CRINONE franchise, services business and proprietary product development programs," concluded Mr. Condella.

As planned, in March the Company filed an Investigational New Drug application for its lead product candidate, COL-1077, a 10% lidocaine bioadhesive gel. The Company expects the first patient will enter a Phase II clinical trial later this quarter. The trial is a randomized, double-blinded, placebo controlled study that will enroll 150 patients at fifteen U.S. sites that intends to evaluate the efficacy of COL-1077 for use as an acute anesthetic for women undergoing transvaginal pipelle-directed endometrial biopsy.

The Company recently announced the licensure of worldwide exclusive rights to a novel intra-vaginal ring ("IVR") technology that enables the delivery of one or more pharmaceuticals at different dosages and release rates in a single segmented ring. This patient administered device will be utilized as a key drug delivery platform for the Company’s emerging proprietary product pipeline. The IVR technology was developed by renowned scientists Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Drs. Langer and Crowley have joined the Company as strategic scientific advisors to guide R&D initiatives and drug development strategy.

The Company’s value creation strategy is to support the continued growth of the CRINONE franchise by its partners Merck Serono and Actavis, expand and maintain a profitable services business by providing unique pharmaceutical development capabilities to global pharmaceutical customers, and invest operating cash flow into a proprietary product pipeline to build long-term shareholder value.

On April 2, 2015 Coronado Biosciences reported it has formed a new subsidiary company, DiaVax Biosciences, to develop novel immunotherapies for the prevention and treatment of cytomegalovirus (CMV), a common virus that affects people of all ages (Press release, Coronado Biosciences, APR 2, 2015, View Source;FID=1500070190 [SID:1234503562]). According to the U.S. Centers for Disease Control and Prevention (CDC), while CMV is typically asymptomatic in healthy individuals, it can cause serious, often life-threatening disease in those with weakened or uneducated immune systems (including developing fetuses exposed to the virus in utero).

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The licensed immunotherapies were developed in the laboratory of Don J. Diamond, Ph.D., Chair of the Department of Experimental Therapeutics at City of Hope National Medical Center in Duarte, California. Dr. Diamond will chair the Scientific Advisory Board of DiaVax. Under the agreement with City of Hope, DiaVax secured worldwide rights to two T-cell immunotherapeutic vaccines for controlling CMV in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. Known as Triplex and PepVax, the programs are expected to enter Phase II clinical studies later this year and are supported by grants from the National Cancer Institute. In connection with the licensing of Triplex and PepVax, DiaVax further entered into an option agreement with City of Hope for exclusive worldwide rights to Pentamer, a universal immunotherapeutic vaccine being developed for the prevention of CMV transmission in utero. If DiaVax exercises its option, and successfully develops and commercializes PepVax, Triplex and Pentamer, City of Hope could receive in excess of $100MM in upfront, milestone and other payments.

Dr. Lindsay A. Rosenwald, Chairman and CEO of Coronado Biosciences, stated, "We are pleased to enter into this collaboration with City of Hope and Dr. Don Diamond. Studies have shown that CMV reactivation in HSCT recipients is linked to low levels of CMV-specific CD8+ T-cells. The vaccines we have licensed represent a promising new T-cell-based, immunotherapeutic approach for controlling CMV in patients with weakened immune systems, particularly those undergoing bone marrow and solid organ transplants. Current antiviral therapies used in this context are often toxic and merely suppress CMV during treatment. An effective vaccine could educate the body’s immune system to fight CMV. We look forward to commencing Phase II studies later this year."

George Megaw, City of Hope’s Director of the Office of Technology Licensing stated, "We are thrilled to partner with Coronado Biosciences on the formation of DiaVax Biosciences and the advancement of these exciting CMV immunotherapies. The executive team at Coronado has an impressive track-record of designing and executing clinical studies across multiple therapeutic areas in a diligent and effective manner. We are confident this collaboration will further the mission of City of Hope to alleviate human suffering and disease, particularly as it relates to CMV."

On April 1, 2015 Cancer Research Technology (CRT) reported that a group of academic organisations and funders has entered an agreement with biopharmaceutical company Basilea Pharmaceutica Ltd. to progress a new family of cancer drugs designed to block several key cancer-causing proteins at once (Press release, Cancer Research Technology, APR 1, 2015, View Source [SID1234523207]).

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The consortium, including The Institute of Cancer Research, London, the Wellcome Trust, Cancer Research Technology (CRT) and The University of Manchester, has granted Basilea exclusive worldwide rights to develop, manufacture and commercialise novel panRAF inhibitors.

The new drug class originated from research at The Institute of Cancer Research (ICR) funded by Wellcome Trust and Cancer Research UK.

The drugs have the potential to be used where a patient’s tumour has developed resistance to existing drugs targeting the BRAF protein, which is mutated in a range of cancers including 50% of melanomas and 10% of bowel cancers.

The drugs target both BRAF and the growth pathways that the cells come to rely on when they become resistant. It is hoped that the new drugs could be effective in patients who have developed drug resistance and exhausted all other available treatments.

Under the terms of the agreement, the consortium will lead phase I clinical development of the new drug, and Basilea will take over responsibility for clinical development after that. In return, the consortium will receive an upfront payment, and potentially milestone payments and royalties if the development of the drug is ultimately successful.

A phase I clinical trial is expected to start later this year at The Royal Marsden NHS Foundation Trust and The Christie NHS Foundation Trust in Manchester. The trial will be funded by the Wellcome Trust, the NIHR Biomedical Research Centre at The Royal Marsden and the ICR, and The Christie charity.

Professor Caroline Springer, Professor of Biological Chemistry at The Institute of Cancer Research, London, said:

"I’m delighted by today’s announcement, which is excellent news for research into treatments for drug-resistant cancers. The agreement provides the foundation for the clinical development of this exciting new drug class. It is an important milestone in efforts to tackle resistance to existing cancer therapies and provide new options for cancer patients."

Dr Richard Seabrook, Head of Business Development at the Wellcome Trust, said: "Resistance to existing cancer drugs can be a tragedy for patients. By targeting multiple cancer-causing proteins, these new panRAF inhibitors could help overcome this problem and have the potential to be of great value in the clinic."

Dr. Laurenz Kellenberger, Basilea’s Chief Scientific Officer, said: "We are excited about complementing our growing and maturing oncology pipeline with this novel program including a lead compound expected to enter clinical testing in 2015. The available data show that this novel class of panRAF inhibitors are active in tumours which have developed resistance to currently available RAF kinase inhibitors and have the potential to offer new treatment options for melanoma as well as additional cancer indications."

Professor Richard Marais, Director of the Cancer Research UK Manchester Institute at The University of Manchester said:

"This agreement represents the culmination of over 10 years of academic research and we are pleased to see our basic research studies being translated into patient benefit. Melanoma is a devastating disease that kills over 2,000 people each year in the UK and we hope that these new drugs will provide new lines of treatment for these patients."

Dr Keith Blundy, Chief Executive of Cancer Research Technology, said: "It’s always very rewarding to see a discovery involving Cancer Research UK funding making that vital first step into the clinic. This agreement is a great example of leading academic and clinical institutions working together with industry and the NHS to translate exciting new discoveries into new treatments that could benefit patients."