Agenus Brain Cancer Vaccine Shows Extended Survival in Phase 2 Final Data Analysis

  • Median Overall Survival Nearly Double than Expected with Standard of Care Alone

LEXINGTON, Mass.-- Agenus Inc. (AGEN), announced final results from a single-arm, multi-institutional, open-label, Phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus’ Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected. In this Phase 2 study, 50% of the patients lived for two years, an encouraging result for a cancer that often kills patients within one year 1-7. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at 2 years and continue to be followed for survival.

Read more: Agenus Inc ( AGEN )

Transcept Pharmaceuticals and Paratek Pharmaceuticals Sign Merger Agreement

Merger to result in NASDAQ-listed biopharmaceutical company whose lead asset is a novel Phase 3-ready, oral and intravenous antibiotic drug candidate designed to address the treatment needs of patients with serious community-acquired bacterial infections.
Upon the closing of the merger, Paratek stockholders will acquire in the aggregate approximately 89.6 percent of the outstanding capital stock of Transcept in exchange for their shares in Paratek, and Paratek will become a wholly owned subsidiary of Transcept. Transcept stockholders will retain their existing equity in Transcept for an aggregate ownership stake of approximately 10.4 percent.
Combined organization expects to be capitalized with cash and cash equivalents of between approximately $108 million and $111 million at the closing of the transaction, comprised of between approximately $15 million and $18 million of cash on hand at Transcept and Paratek and an additional approximately $93 million from a broad investor syndicate comprised primarily of new investors as well as certain existing Transcept and Paratek stockholders.
Immediately prior to the closing of the transaction, existing Transcept stockholders will receive a special dividend of cash, as well as rights to future royalties on INTERMEZZO sales, and potential proceeds from any sale of INTERMEZZO and TO-2070 assets within 24 months following closing.

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Researchers Demonstrate Promise of Dicerna Investigational Therapy in Preclinical Model of Primary Hyperoxaluria Type 1 (PH1)

DCR-PH1 Uses Proprietary Dicer Substrate RNAi Technology to Inhibit Enzyme Implicated in Rare Liver Disorder

WATERTOWN, Mass.--Dicerna Pharmaceuticals, Inc. (DRNA), a leader in the development of RNAi-based therapeutics, today announced the presentation of preclinical data demonstrating the promise of DCR-PH1, the Company’s therapeutic candidate for the treatment of primary hyperoxaluria type 1 (PH1), a rare inherited liver disorder that often results in progressive and severe kidney damage. The research was presented at the 11th International Primary Hyperoxaluria Workshop in Chicago by Eduardo Salido, Ph.D., Professor of Pathology at the University of La Laguna in Santa Cruz de Tenerife, Spain.

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Amicus Therapeutics Provides Updates and Final Analysis Plan for Phase 3 Fabry Monotherapy Study 012

Last Patient Completes 18-Month Primary Treatment Period - Top-Line Data on Track to Report in 3Q14
96% of Patients with Amenable Mutations Elected to Continue in 12-Month Treatment Extension
Statistical Analysis Plan Finalized

CRANBURY, N.J., June 30, 2014 -- Amicus Therapeutics (FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today provided updates and detailed the statistical analysis plan for its second Phase 3 study (Study 012) of the oral small molecule pharmacological chaperone migalastat HCl ("migalastat") monotherapy for Fabry patients with amenable mutations. The 18-month primary treatment period is now complete and top-line data from Study 012 are expected in the third quarter of 2014. If successful, Study 012 will trigger the process for European regulatory approval of migalastat as a monotherapy for Fabry patients with amenable mutations.

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Rosetta Genomics Receives Notice of Allowance for U.S. Patent for the Prognosis and Treatment of Prostate Cancer

PRINCETON, NJ and REHOVOT, ISRAEL-- Jun 26, 2014 - Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics and therapeutics, announces receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 13/390,995, entitled "Compositions and Methods for Prognosis and Treatment of Prostate Cancer." The patent claims cover the expression of miR-205 as an indicator of good prognosis and relates to methods and kits for prognosis of prostate cancer.

Prostate cancer typically is first suspected by elevated levels of serum Prostate Specific Antigen (PSA). However, PSA levels are often elevated for reasons unrelated to prostate cancer. Although an elevated PSA level often leads to biopsy, about 80% of all prostate biopsies are either negative or indicate a low likelihood of high-grade cancer. Further complicating prostate cancer diagnosis and treatment is the difficulty in determining which cancers are low-risk and which are high-risk.

Read more: Rosetta Genomics Ltd ( ROSG )