On September 5, 2014 Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense reported the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin) (Press release, Soligenix, SEP 5, 2014, View Source [SID:1234512914]). SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of cutaneous T-cell lymphoma (CTCL) and is highly synergistic with the company’s existing development pipeline. As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data.

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SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet A (UVA) exposure. Topical hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, placebo-controlled, clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to topical hypericin treatment compared to only 8.3% receiving placebo (p ? 0.04). These clinical data fully support advancing this therapy to a pivotal Phase 3 clinical trial in CTCL. The Phase 3 clinical protocol of SGX301 for the treatment of CTCL is currently in final review with the US Food and Drug Administration (FDA).

SGX301 has received orphan drug designation by the FDA for the treatment of CTCL, which provides for 7 years of market exclusivity upon approval in the US. SGX301 is being developed pursuant to discoveries made at New York University Medical Center together with the Yeda Research and Development Company, Ltd., which is the commercial arm of the Weizmann Institute of Science in Rehovot, Israel.

In addition to SGX301, the acquired technology package includes preclinical and clinical data supporting other potential indications for hypericin photodynamic therapy, such as psoriasis. Psoriasis is an autoimmune inflammatory disease that is similarly characterized by cutaneous accumulation of T-cell lymphocytes but without cancerous transformation. It is a common disease that affects over 7 million adults in the US. Photodynamic therapy is a frequently employed initial therapy for psoriasis, despite the need for ultraviolet light exposure and its attendant risk of melanoma and non-melanoma skin cancer. The Phase 2 clinical study has shown that hypericin and visible light phototherapy is also effective in treating these lesions.

"We are very excited by the acquisition of this late-stage technology which has the potential to be the first photodynamic therapy approved for CTCL," stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix. "With SGX301 we will be able to leverage our clinical development expertise in cancer and cancer supportive care. We also anticipate the potential for a number of federal funding opportunities for SGX301 in this orphan disease, as well as for expansion into other indications of unmet medical need."

On September 4, 2014 Merck reported that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor (Press release Merck & Co, SEP 4, 2014, View Source [SID:1234500721]). This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA’s Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24 percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response.

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to fight advanced melanoma. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumor cells and healthy cells. Immune-mediated adverse reactions occurred with KEYTRUDA including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered. Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus. For more information regarding immune-mediated adverse reactions and use in pregnancy, see "Selected Important Safety Information" below.

"KEYTRUDA embodies Merck’s unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "We are grateful to the people with advanced melanoma who participated in our trials, and the scientific and medical community for the shared effort that has led to the accelerated approval of KEYTRUDA."

"The accelerated FDA approval of KEYTRUDA is a meaningful development for patients with advanced melanoma," said Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the pembrolizumab melanoma clinical program. "Our new ability to target the PD-1 pathway with KEYTRUDA is a very exciting step in the immunotherapy field."

Merck is conducting ongoing Phase 2 and 3 clinical studies in advanced melanoma, which are designed to provide further confirmatory evidence for KEYTRUDA in this indication. Merck plans to make KEYTRUDA available within one week from today’s FDA approval.

On September 3, 2014 Adherex Technologies Inc. (TSX: AHX; OTC: ADHXF) (the "Company") reported that it gave effect to the consolidation of its outstanding share capital on the basis of one new security for every three outstanding securities (the "Consolidation") (Press release, Fennec Pharmaceuticals, SEP 3, 2014, View Source [SID:1234510425]). In addition, the Company filed a Notice of Alteration with the British Columbia Registrar of Companies changing the name of the Company from Adherex Technologies Inc. to Fennec Pharmaceuticals Inc. to better reflect its current business focus and activities (the "Name Change"). The Company’s Common Shares post-Consolidation will trade on the TSX Exchange under a new trading symbol: FRX.

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The Consolidation will reduce the number the Company’s outstanding common shares (the "Common Shares") from approximately 29.6 million (as last reported in the Company’s most recent Quarterly Report on Form 10-Q), to approximately 9.9 million. Furthermore, as a result of the Consolidation, Adherex’s outstanding common share purchase warrants will be exercisable as follows: (i) with respect to the warrants issued by the Company on or about April 30, 2010 and March 29, 2011 and not tendered as part of the warrant exchange completed on July 29, 2014 (the "Warrant Exchange"), each 54 warrants will entitle the holder to purchase one Common Share at an exercise price of CAD$4.32, (ii) with respect to the warrants that were exchanged in connection with the Warrant Exchange, each three warrants will entitle the holder to purchase one Common Share at an exercise price of USD$1.50, and (iii) with respect to the warrants issued on November 22, 2013, each three warrants will entitle the holder to purchase one Common Share at an exercise price of USD$1.50.

All materials necessary to effect the Consolidation and the Name Change are expected be filed with the Toronto Stock Exchange (the "TSX") today and, subject to TSX approval, it is expected that the Common Shares will commence trading on the TSX under the new name and "FRX" trading symbol, as well as on a Consolidated basis on or about September 5, 2014. Letters of transmittal providing for the exchange of certificates representing pre-Consolidation Common Shares for certificates representing post-Consolidation Common Shares were mailed to registered shareholders today. Any pre-Consolidation Common Shares owned by beneficial holders and any outstanding warrants will automatically be adjusted as a result of the Consolidation and the Name Change and no further action is required to be taken by such shareholders or warrantholders.