Columbia Laboratories, Inc. to Become Juniper Pharmaceuticals, Inc.

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.

CEL-SCI REPORTS 3rd CONSECUTIVE MONTH OF RECORD PATIENT ENROLLMENT IN 2015 FOR ITS PHASE III HEAD AND NECK CANCER TRIAL

On April 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) reported that in March it has enrolled 29 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) (Press release, Cel-Sci, APR 1, 2015, View Source [SID:1234506998]). March marks the third consecutive month of record enrollment for CEL-SCI this year following January and February, 2015. 406 patients have been enrolled in the Phase III study as of March 31, 2015.

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"The accelerating pace of enrollment in our trial is very good. We expect to see continued increases in monthly patient enrollment throughout the year as new clinical centers are added and as existing centers gain more experience with Multikine," stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body’s natural immune system in the fight against tumors. CEL-SCI’s Clinical Research Organization, who runs the study for CEL-SCI, is aiming to complete enrollment of about 880 patients to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in over 25 countries.

In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

Consortium signs deal with Basilea to develop resistance-busting cancer drugs

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."

NT 10-K – Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405

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

TNI BioTech 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, TNI BioTech, MAR 31, 2015, View Source [SID1234502896]).

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