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Until earlier this October, the only time I had visited Ireland was in April of 1989, on the World B. Tour. A group of American former collegiate basketball players came to the Emerald Isle on a…
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We’re excited to announce that we have recruited two cardiometabolic experts to our Medical City campus in Lake Nona (Orlando), Fla. Peter A. Crawford, M.D., Ph.D., and Andre d’Avignon, Ph.D., join our Cardiovascular Pathobiology Program from Washington University in St. Louis, Mo.
ViaCyte’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 1 diabetes. This Phase 1/2 clinical trial, designed to evaluate the VC-01 product candidate directly in patients with type 1 diabetes, is initially being conducted at UC San Diego Health System, with the support of the UC San Diego Sanford Stem Cell Clinical Center, under the direction of Principal Investigator Robert Henry, MD.
Dr. Paul Laikind, President and CEO of ViaCyte, said, “We are very excited to begin the clinical stage of development in our quest to transform the way patients with type 1 diabetes are impacted by the disease. To our knowledge, this is the first time that an embryonic stem cell-derived cell replacement therapy for diabetes has been studied in human subjects, and it represents the culmination of a decade of effort by the ViaCyte team, our collaborators, and our supporters at the California Institute for Regenerative Medicine and at JDRF.”
The loss or malfunction of insulin-producing beta cells is the primary cause of type 1 diabetes, making it a promising target disease for cell replacement therapy. ViaCyte’s VC-01 product candidate delivers pancreatic precursor cells (called PEC-01™ cells) that are designed to further differentiate and mature after surgical implantation, not only to fully functioning insulin-producing beta cells, but also to other endocrine cell types that make up the normal human pancreatic islet. Thus, along with the critically important insulin, the implanted cells are expected to produce other hormones that are important for the regulation of glucose (sugar) in the blood, including, for example, glucagon, somatostatin, and amylin.
The PEC-01 cells are delivered under the skin in a proprietary device with a selectively porous cell-impermeable membrane, called the Encaptra® drug delivery system. The Encaptra device is designed to protect the implanted cells from possible immune rejection, to permanently contain the cells and prevent their distribution away from the implantation site, and to provide a platform for product vascularization.
The ongoing Phase 1/2 clinical trial is evaluating the VC-01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. In addition to determining the safety of the product candidate in these patients, the study is designed to evaluate the effectiveness of the VC-01 product candidate in replacing the lost endocrine function that is central to the disease. In an open-label, dose-escalating format, ViaCyte expects to enroll approximately 40 patients in the study at multiple clinical sites.
About Type 1 Diabetes Type 1 diabetes mellitus (previously called juvenile diabetes) is a life-threatening chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow glucose to enter cells to produce energy. It is typically diagnosed during childhood or adolescence, though it can also arise in adults. Though less common than type 2 diabetes, which occurs when the body becomes resistant to insulin, type 1 diabetes affects several million Americans, according to JDRF, the leading global organization focused on type 1 diabetes research. Currently, there is no cure for type 1 diabetes and the risk of long-term complications is high even with diligent treatment. Standard treatment involves multiple daily injections of insulin and rigorous management of diet and lifestyle.
About ViaCyte ViaCyte is a privately-held regenerative medicine company focused on developing a novel cell therapy for the treatment of diabetes. ViaCyte’s lead product candidate, the VC-01 combination product, is based on the production of pancreatic progenitor cells derived from human pluripotent stem cells. These progenitor cells are implanted in a durable and retrievable encapsulation device. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. VC-01 is being developed as a potential long-term diabetes treatment without immune suppression, and without risk of hypoglycemia or other diabetes-related complications.
ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine and JDRF. For more information, please visit www.viacyte.com.
About Sanford Stem Cell Clinical Center at UCSD The Sanford Stem Cell Clinical Center was recently created to advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapies.
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SOURCE ViaCyte, Inc.
MEI Pharma 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 ME-344 in combination with topotecan in patients with small cell lung or ovarian cancer who failed initial therapy.
The cohort expansion comes after the initial stage of the study confirmed the maximum tolerated dose (MTD) of ME-344 in combination with topotecan is 10mg/kg, the same dose defined for single agent use. Now the study will enroll an additional 40 patients into two cohorts: locally advanced or metastatic small cell lung cancer and ovarian cancer.
“This milestone represents another important step forward for the clinical development of ME-344,” said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. “While we remain focused on our lead drug candidate Pracinostat, we continue to be very excited by the potential of this novel mitochondrial inhibitor. ME-344 has shown broad and potent anti-tumor activity in pre-clinical studies, followed by promising single-agent activity in the clinic. Now we look forward to assessing its clinical activity in combination with chemotherapy and reporting on its progress in the months ahead.”
The Phase Ib study is evaluating the combination of intravenous ME-344 and topotecan (trade name Hycamtin®), a drug approved by the U.S. Food & Drug Administration for the treatment of small cell lung, ovarian and cervical cancers. Following the initial stage of the study, an independent Safety Committee determined the recommended Phase II dose for continued testing of ME-344 to be 10 mg/kg in combination with 4 mg/m2 of topotecan. The combination of ME-344 and topotecan has been generally well tolerated; the most frequent side effects of the combination are fatigue and gastrointestinal disturbances.
In October 2013, results from a Phase I clinical study of ME-344 were presented showing preliminary evidence of single-agent activity in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who achieved stable disease or better. Notably, one patient with small cell lung cancer achieved a confirmed partial response and remained on study for 104 weeks. ME-344 was generally well tolerated in the study at doses equal to or less than 10 mg/kg delivered on a weekly schedule for extended durations. Dose limiting toxicities were observed at both the 15 and 20 mg/kg dose levels, consisting primarily of Grade 3 peripheral neuropathy.
ME-344 is a mitochondrial inhibitor drug candidate derived from MEI Pharma’s isoflavone-based technology platform. In preclinical studies, ME-344 has been shown to cause cell death in multiple human tumor cell lines, including ovarian cancer stem cells, by interfering with mitochondrial energy generation. In April 2013, Ayesha Alvero, MD, Yale University School of Medicine, presented data at the American Association for Cancer Research Annual Meeting showing the ability of ME-344 to decrease tumor burden and delay recurrence in a pre-clinical in vivo model of recurrent epithelial ovarian cancer, the most lethal of all gynecological malignancies.
MEI Pharma owns exclusive worldwide rights to all of its drug candidates, including ME-344.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s lead drug candidate is Pracinostat, a potential best-in-class, oral histone deacetylase (HDAC) inhibitor currently in development for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). In August 2014, the Company completed enrollment in a randomized, placebo-controlled Phase II study of Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk MDS. The Company plans to unblind the study and report topline data in Q1 2015. Preliminary data from an ongoing Phase II study of Pracinostat plus azacitidine in elderly patients with newly diagnosed AML showed responses in six of the first nine patients enrolled in the study (67%), including three patients who achieved a CR or CRi as their initial response. MEI Pharma is also developing ME-344, a mitochondrial inhibitor that has shown preliminary evidence of single-agent activity in a first-in-human clinical study in patients with refractory solid tumors. In September 2013, the Company further expanded its pipeline of drug candidates with the acquisition of PWT143, a highly selective PI3K delta inhibitor. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
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SOURCE MEI Pharma, Inc.
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 6, 2014 at 4:00 p.m. Eastern Standard Time (1:00 p.m. Pacific Standard Time).
Trovagene’s senior management team will host a conference call on Thursday, November 6, 2014 at 5:00 p.m. Eastern Standard Time (2:00 p.m. Pacific Standard Time) to discuss the results and update investors on the Company’s progress.
A live webcast of the call will be available online at www.trovagene.investorroom.com/overview. To access the conference call, please dial (887) 347-6081 (domestic), (412) 902-4285 (international), or (855) 669-9657 (Canada), conference ID# 10054927. To access the telephone replay of the call, dial (877) 344-7529 (domestic), (412) 317-0088 (international), or (855) 669-9658 (Canada), replay ID# 10054927. The webcast and telephone replay will be archived on the company’s website following the call.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.
David Moskowitz and Amy Caterina
Canale Communications, Inc.
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SOURCE Trovagene, Inc.
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…
SAN DIEGO, Oct. 29, 2014 /PRNewswire/ –Imprimis Pharmaceuticals, Inc. (Nasdaq: IMMY) today announced that it has entered into a license agreement, under which Imprimis acquired the US rights to commercially compound a patented combination of alkalized lidocaine and heparin from Urigen Pharmaceuticals, Inc….
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…