San Diego biotech news from BioSpace, Xconomy, PR Newswire, Marketwired and other sources, click on headlines to read the full story.
SAN DIEGO, Oct. 29, 2014 /PRNewswire/ — Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease and cancer, disclosed today that it will provide Hemopurifier therapy under FDA compassionate use access provisions to support potential requests…
ViaCyte, Inc. (Formerly Known as Novocell, Inc.)’s VC-01??? Investigational Stem Cell-Derived Islet Replacement Therapy Successfully Implanted Into First Patient
SAN DIEGO, Oct. 29, 2014 /PRNewswire/ — ViaCyte, Inc., a privately-held regenerative medicine company, announced today that the first patient in its Phase 1/2 study was successfully implanted with VC-01, its embryonic stem cell-derived islet replacement product candidate being developed as a treatment for type…
LA JOLLA, Calif., Oct. 28, 2014 /PRNewswire/ –Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company developing innovative medicines targeting microRNAs,today announced the pricing of an underwritten public offering of 5,294,118 shares of its common stock at a price to the public of …
Regen BioPharma ‘s Chief Scientific Officer Examines Potential Role Of Immunotherapeutic Treatment For Ebola In Conjunction With Other Current Therapies
SAN DIEGO, CA–(Marketwired – October 28, 2014) – Regen BioPharma Inc.’s (OTCBB: RGBP) Chief Scientific Officer Dr. Thomas Ichim stated today that The Company is currently identifying potential immunotherapeutic treatments that might have value in treating some of the effects of Ebola in conjunction with other…
MEI Pharma (MEIP) (Formerly known as Marshall Edwards, Inc.) Advances Clinical Study Of Mitochondrial Inhibitor ME-344 In Small Cell Lung And Ovarian Cancers
SAN DIEGO, Oct. 29, 2014 /PRNewswire/ — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patient has been dosed in the cohort-expansion stage of the Company’s Phase Ib clinical study of investigational drug candidate…
TrovaGene, Inc. Schedules Release Of Third Quarter 2014 Financial Results And Investor Conference Call
SAN DIEGO, Oct. 29, 2014 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that it will report financial results for the third quarter and the nine months ended September 30, 2014 on Thursday, November…
Eisai Inc. And Arena Pharmaceuticals, Inc. Report Results Of An Investigational Pilot Study Of Coadministration Of Lorcaserin Hcl And Phentermine Hcl
WOODCLIFF LAKE, N.J. and SAN DIEGO, Oct. 28, 2014 /PRNewswire/ –Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced top-line results of a pilot study to assess the safety of lorcaserin HCl, a serotonin 2C receptor agonist, when coadministered with phentermine…
Veracyte, Inc. Announces New Data Supporting Clinical Validity of Afirma® Gene Expression Classifier
SOUTH SAN FRANCISCO, Calif., Oct. 29, 2014 /PRNewswire/ – Veracyte, Inc. (Nasdaq: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, today announced new data from two studies supporting the use of the company’s Afirma Gene Expression Classifier (GEC) to help reduce unnecessary surgeries among patients whose thyroid nodules are indeterminate for cancer following traditional cytopathology review of their fine needle aspiration (FNA) biopsies. The data are being presented at the 84th Annual Meeting of the American Thyroid Association in Coronado, Calif., October 29 – November 2.
A poster entitled, “Long Term Clinical and Imaging Follow-Up of an Office-Based Gene Expression Classifier Used to Manage Thyroid Nodules” (Poster #269), summarized data from a study of patients with thyroid nodules who avoided surgery due to benign Afirma GEC results and were followed for up to three years. All 13 patients in the single-center study remained cancer-free, based on physical exam and ultrasound findings. Additionally, three patients with benign Afirma genomic test results who underwent surgery due to clinical symptoms were confirmed to have benign nodules – further validating the genomic test’s accuracy.
“This is the first known study to assess the durability and safety of Afirma GEC results for up to three years,” said Dr. Brian Michael of Wellspan Health in Gettysburg, Penn., who will present the new data. “In this relatively small sample, 13 patients who would have previously been referred for surgery were able to safely avoid it. These findings should give physicians further confidence in moving patients with benign Afirma GEC results from diagnostic surgery to routine monitoring.”
A poster entitled, “Performance of the Afirma Gene Expression Classifier on Indeterminate Thyroid Fine Needle Aspirates (FNAs) From Large Nodules” (Poster #39), summarized the Afirma GEC’s performance on cytologically indeterminate nodules of >3 cm for which surgical pathology results were subsequently available. All five nodules identified as benign by the Afirma GEC were confirmed by surgery as benign, for a test sensitivity of 100% – underscoring the test’s accuracy regardless of nodule size.
“These two new studies add to the growing body of evidence supporting the ability of Veracyte’s Afirma GEC to accurately rule out cancer in thyroid nodules that are deemed indeterminate by traditional cytopathology,” said Bonnie Anderson, president and CEO of Veracyte. “These findings are consistent with findings from the pivotal clinical validation study published in the New England Journal of Medicine in 2012, and taken together reinforce the Afirma GEC as a new standard for helping thyroid nodule patients avoid unnecessary thyroid surgery and the anxiety, costs and need for lifelong thyroid hormone therapy that can accompany such surgery.”
Approximately 525,000 thyroid nodule FNA procedures are performed each year in the United States. FNA samples can be challenging to interpret by cytopathology review and produce indeterminate results in 15% to 30% of cases. Guidelines have traditionally recommended surgery for patients with indeterminate results to assess whether the nodules are benign or malignant. Studies have shown that approximately 70% to 80% of the time, the nodules prove to be benign following surgery.
Veracyte (Nasdaq: VCYT) is pioneering the field of molecular cytology, focusing on genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s first commercial solution, the Afirma® Thyroid FNA Analysis, centers on the proprietary Afirma Gene Expression Classifier (GEC) to resolve ambiguity in diagnosis and is becoming a new standard of care in thyroid nodule assessment. Since launching its Afirma solution in 2011, Veracyte estimates it has helped approximately 10,000 patients with thyroid nodules avoid unnecessary surgery, reducing healthcare costs by millions of dollars. Afirma is recommended in leading practice guidelines and is covered for more than 135 million lives in the United States, including through Medicare and most commercial insurance plans. Veracyte intends to expand its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. The company is in late product development for a genomic test to resolve preoperative ambiguity in lung nodules that are suspicious for cancer. Veracyte is also developing a second product in pulmonology, targeting interstitial lung diseases that include idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our test; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
Veracyte, Afirma, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc. This press release also contains trademarks and trade names that are the property of their respective owners.
Media:Tracy Morris650-380-4413 Tracy.Morris@Veracyte.com
Investors:Angeli KolhatkarBurns McClellan, Inc.email@example.com
Dengue, Chikungunya also transmitted by Aedes aegypti mosquitoes.
SAN DIEGO, Oct. 28, 2014 /PRNewswire/ — Ambit Biosciences Corporation (hereinafter, Ambit Biosciences) (NASDAQ: AMBI) today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR”) in connection with Daiichi Sankyo’s previously announced tender offer for all of the outstanding common stock of Ambit Biosciences (hereinafter, the Tender Offer).
Expiration of the HSR waiting period satisfies one of the conditions to the closing of the Tender Offer. Completion of the Tender Offer is also conditioned on the acquisition of one share more than 50 percent of Ambit Biosciences’ outstanding common stock (including shares issuable pursuant to options and warrants for which Ambit Biosciences has received exercise notices) and other customary closing conditions.
Daiichi Sankyo, through its wholly-owned U.S. subsidiary, Charge Acquisition Corp., launched the Tender Offer on October 10, 2014 to purchase the outstanding shares of Ambit Biosciences’ common stock for $15.00 per share plus one non-transferable contingent value right per share that will entitle the holder thereof to a maximum payment of $4.50 upon the achievement of certain commercialization related milestones regarding quizartinib. Failing any extension to the offer period, the offer is due to expire at 5:00 P.M. U.S. Eastern Time on November 10, 2014.
About Daiichi SankyoDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a “Hybrid Business Model,” to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com.
The Daiichi Sankyo oncology portfolio continues to grow and currently includes both small molecules and monoclonal antibodies with novel targets in both solid and hematologic cancers.
About Ambit BiosciencesAmbit Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of drugs to treat unmet medical needs in oncology, autoimmune and inflammatory diseases by inhibiting kinases that are important drivers for those diseases. Ambit’s lead drug candidate, quizartinib (AC220), is a once-daily, orally-administered potent and selective, inhibitor of FMS-like tyrosine kinase-3 (FLT3) and is currently in a registrational phase 3 clinical trial, referred to as QUANTUM-R, in patients with relapsed/refractory FLT3-ITD positive, acute myeloid leukemia (AML). Quizartinib is also being studied in newly diagnosed patients in combination with chemotherapy as well as maintenance following a hematopoietic stem cell transplantation (HSCT). In addition to quizartinib, Ambit’s clinical pipeline includes AC410, an oral JAK2 inhibitor, and CEP-32496, a BRAF inhibitor licensed to Teva Pharmaceutical Industries Ltd. Ambit’s preclinical portfolio includes a proprietary CSF1R inhibitor program.
Forward Looking Statements This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the proposed transaction between Daiichi Sankyo and Ambit Biosciences; the expected timetable for completing the transaction; Ambit Biosciences’ product candidates, including regarding the therapeutic and commercial potential of quizartinib, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: the possibility that certain closing conditions to the transaction will not be satisfied; that required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the ability to timely consummate the transaction and possibility that the transaction will not be completed; the anticipated benefits of the transaction may not be realized; risks related to drug development and commercialization; and those additional factors discussed in Ambit Biosciences’ most recent Quarterly and Annual Reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (hereinafter, the SEC). Ambit Biosciences cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Ambit Biosciences undertakes no obligation to update or revise any of these statements.
Important Additional Information This news release is provided for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Ambit Biosciences Corporation or any other securities. Daiichi Sankyo Company, Limited and its wholly owned subsidiary Charge Acquisition Corp. have commenced a tender offer for all outstanding shares of common stock of Ambit Biosciences Corporation and have filed with the SEC a tender offer statement on Schedule TO (including an Offer to Purchase, a Letter of Transmittal and related documents), which will be amended as necessary. Ambit Biosciences Corporation has filed with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9, which will be amended as necessary. These documents contain important information, including the terms and conditions of the Tender Offer, and stockholders of Ambit Biosciences Corporation are advised to carefully read these documents before making any decision with respect to the Tender Offer. Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov. In addition, the Solicitation/Recommendation Statement and related documents may be obtained for free by contacting the investor relations department of Ambit Biosciences Corporation at firstname.lastname@example.org. The Offer to Purchase and related documents may be obtained for free by contacting the investor relations department of Daiichi Sankyo at email@example.com or by directing such requests to the information agent for the tender offer, Mackenzie Partners, Inc., at (800) 322-2885 (toll-free for stockholders) or (212) 929-5500 (collect for bank and brokers).
Marcy GrahamExecutive Director, Investor Relations & Corporate CommunicationsAmbit Biosciences Corporation firstname.lastname@example.org 858-334-2125
SOURCE Ambit Biosciences