|RXi Pharma Announces Positive Interim Results in Phase 2a RXI-109; Cerulean Announces Completion of Enrollment of Randomized Phase 2 Trial of CRLX101|
|By William Kent|
|Thursday, 15 October 2015 19:49|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 15, 2015.
RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company that owns a broad intellectual property portfolio including a unique self-delivering RNAi platform, today announced that results from a blinded panel and an Investigator review show that incision sites treated with RXI-109 after scar revision surgery achieved better scores as compared to control incision sites in the same subjects, three months post scar revision surgery.
"The use of RXI-109 after scar revision surgery has a visible, beneficial effect on suppression of hypertrophic scarring as compared with untreated control scars, at three months following surgery," said Dr. Joseph P. Hunstad, FACS, Founder of The Hunstad Kortesis Center for Cosmetic Plastic Surgery and MedSpa, one of the Principal Investigators in this RXI-109 study.
In the first two arms of this ongoing Phase 2a study, subjects were given six intradermal injections of RXI-109, either at 5 mg/cm or 10 mg/cm, beginning two weeks after scar revision surgery, with the last of the six doses administered three months post revision surgery. Subjects had one portion of the revised scar treated with RXI-109, whereas another part of the scar was revised but left untreated. This 3-month analysis included 16 subjects of which 15 were evaluable and 1 was lost to follow-up. Of those 15 subjects, eight were treated with 5 mg/cm of RXI-109 and seven were treated with 10 mg/cm of RXI-109.
All subjects were assessed using four different evaluation methods:
- POSAS (Physician and Observer Scar Assessment Scale): A compiled score based on investigator assessments of factors contributing to scar quality. These scores are provided by the investigators for both the treated and the untreated portion of the scar of their individual subjects in person;
- VAS (Visual Analogue Scale): A score based on a 10 point scale ranging from "1" (fine line scar) to "10" (worst scar possible) provided by the investigators for their individual subjects;
- A blinded assessment of photographs of the revision sites for 15 subjects by Investigators in which the clinicians were asked to indicate for Scars A and B as to which is 'better' or 'not different';
- A separate assessment of photographs of the revision sites for 15 subjects by a blinded panel, separate from the Investigators, in which the panel members were asked to indicate for Scars A and B as to which is 'better' or 'not different' .
Overall, the RXI-109 treated revision sites were scored statistically significantly better than the untreated revision sites in all four evaluations. Both dose levels of RXI-109 were equally well tolerated with occasional transient redness and itching occurring in both dose levels. Moreover, the higher dose of 10 mg/cm did not appear to add clinical benefit over the 5 mg/cm dose, leading to the conclusion that the next cohorts in this ongoing RXI-109-1402 study will be treated with the 5 mg/cm dose. These subsequent cohorts will include evaluation of additional treatments through six months to further define the optimum treatment regimen.
"We are very pleased with the outcome of the 3-month evaluation of our ongoing Phase 2a study with RXI-109 for the treatment of hypertrophic scars following scar revision surgery," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added, "Not only do these four different evaluation methods confirm the same positive conclusion, the results also bring us another step closer to identifying the final treatment schedule for RXI-109 in the management of surgical incision sites in subjects prone to hypertrophic scarring. Our continued clinical development will now focus on identifying the optimum treatment length using the 5 mg/cm dose".
Dr. Cauwenbergh will present data from the Company's dermal clinical program with RXI-109 today at 4:30 p.m. EDT at the Dawson James Securities Stock Growth Conference. The presentation will be webcast and available on the "Investors" section of the Company's website, www.rxipharma.com.
Cerulean Pharma Inc. (NASDAQ: CERU), a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced completion of enrollment of a randomized Phase 2 trial of its lead NDC, CRLX101, in combination with Avastin®, in third- and fourth-line relapsed renal cell carcinoma (RCC). The trial has enrolled all 110 patients and the company expects to announce top-line data in the first half of 2016.
"This is an exciting time in the evolution of RCC treatments," said Martin H. Voss, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center and Principal Investigator for the trial. "Currently approved treatment options provide limited benefit to heavily pretreated patients, and the therapeutic approach in the third- and fourth-line setting is poorly defined. There remains a clear need for a different mechanistic approach, so I am pleased that we have completed enrollment and look forward to the results."
"Completing enrollment in this Phase 2 trial marks a significant milestone for the company," stated Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. "We are grateful for the dedication demonstrated by the patients and the clinical investigators that are participating in this trial."
The Phase 2 trial compares CRLX101 in combination with Avastin to investigator's choice of standard of care in patients with RCC who have received two or three prior lines of therapy. The primary endpoint is investigator-assessed progression free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. PFS also will be evaluated by blinded independent radiological review. Other secondary endpoints include overall response rate, duration of response and overall survival. The trial is sized to show a 2.3 month improvement over an expected 3.5 month median PFS for standard of care with a hazard ratio of 0.6, meaning that the trial is expected to show whether CRLX101 plus Avastin provides a 40% improvement in PFS over available third- and fourth-line treatments.
22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today an important new initiative in plant biotechnology: 22nd Century has entered into a new cannabis research collaboration with strategic partner Anandia Laboratories, Inc. (Anandia), based in Vancouver, Canada. As a part of this research collaboration, Anandia will develop and grow cannabis strains that express highly desirable characteristics and will lead to exciting commercialization opportunities. Dr. Paul Rushton, 22nd Century’s new Vice President of Plant Biotechnology, will have responsibility for this partnership with Anandia. The Company last year announced that Botanical Genetics, LLC (a wholly owned subsidiary of 22nd Century Group) entered into a worldwide license agreement with Anandia that granted exclusive rights to 22nd Century in the United States to four genes required for cannabinoid production in the cannabis plant. The license also granted 22nd Century co-exclusive rights with Anandia to this proprietary technology in all countries outside of the U.S. and Canada. Anandia retained exclusive rights in Canada. The proprietary technology licensed from Anandia allows for the development of cannabis strains that demonstrate either an increase or decrease in the production and content of all, or certain subsets of, cannabinoids. The long-term goals of the Company’s research activities relating to cannabis are to develop, protect and commercially produce unique cannabis plant varieties that include high levels of non-THC cannabinoids, such as CBD, for the legal medical marijuana markets, as well as virtually cannabinoid-free cannabis for the commercial hemp industry.
Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, today announced that it will host its Research and Development (R&D) Day for investors and analysts on Friday, October 23, 2015. The event will take place from 9:00 a.m. to 12:00 p.m. EDT in New York City. At R&D Day, Acceleron and its collaboration partner, Celgene, will review the Phase 3 clinical development plan for luspatercept in myelodysplastic syndromes (MDS) and beta-thalassemia. Acceleron will present preliminary Phase 1 results from ACE-083, its locally-acting muscle therapeutic, and provide updates on sotatercept and dalantercept in chronic kidney disease and cancer, respectively. In addition, the company will introduce its new drug discovery platform, IntelliTrapTM and ACE-2494, a systemic muscle therapeutic and the first clinical candidate to emerge from this platform. Along with the Acceleron team, presentations will be given by outside experts to discuss the luspatercept clinical program and disease treatments, including MDS, beta-thalassemia and muscular dystrophies.
Affymetrix Inc. (NASDAQ: AFFX) and Luminex Corporation (NASDAQ: LMNX) today announced a distribution agreement under which eBioscience, a business unit of Affymetrix, will sell Luminex’s MAGPIX®, Luminex® 200™ and FLEXMAP 3D® multiplexed assay platforms in specified countries in the Americas, Asia and Europe. Affymetrix will sell the Luminex instruments together with ProcartaPlex® multiplexed immunoassays and QuantiGene® Plex multiplexed quantitative gene expression assays, offering complete solutions to customers working in the fields of drug discovery and development, immuno-oncology and translational research. The agreement will strengthen continued growth and adoption of Affymetrix’ bead-based assay portfolio, which serves markets growing at double-digit rates worldwide, while expanding the Luminex instrument installed base. The distribution agreement covers the U.S., Canada, Mexico, Brazil and China as well as The Netherlands, Germany, France, U.K., Switzerland, Austria, Belgium, Ireland, Luxembourg and Poland. “We are pleased to enter into this agreement with Luminex, the leading instrument provider supporting bead-based multiplexed assays,” said Dara Grantham Wright, senior vice president and general manager of the eBioscience business unit at Affymetrix. “This agreement deepens our relationship with Luminex, and will provide our customers an integrated solution to access a best-in-class platform with an ever-expanding, high-quality assay menu.” “By enabling Affymetrix to offer both Luminex multiplexing instruments and Affymetrix assays, we can further drive accessibility to customers focused on disease-related research around the world,” said Todd Bennett, vice president, global sales and customer operations, Luminex Corporation. “We are very pleased to enter into this agreement, and to support Affymetrix in its efforts to bring flexible, high-quality solutions to laboratories working in the fields of drug discovery and development, immuno-oncology and translational research.” Financial terms were not disclosed.
Arcadia Biosciences, Inc. (NASDAQ:RKDA), an agricultural technology company, today announced its plan to release its third-quarter 2015 financial and business results after market close on November 5, 2015. The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss third-quarter results and the quarter’s key strategic achievements. Interested participants can join the conference call using the following numbers: U.S. Toll-Free Dial-In: +1-855-546-9560; International Dial-In: +1-412-455-6124 -- Passcode: 60422408. A live webcast of the conference call will be available on the “Investors” section of the Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.
Bristol-Myers Squibb (NYSE:BMY) today announced that the National Institute for Health and Care Excellence (NICE) has recommended Daklinza (daclatasvir) in England and Wales for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. Specifically, NICE recommended Daklinza, an oral, once-daily medication used in combination with other agents, to treat certain patients with HCV genotypes 1, 3 and 4. Approximately 214,000 people in the UK are thought to have chronic HCV, and roughly 100,000 of those patients are estimated to have genotype 3, a difficult-to-treat and often aggressive form of chronic HCV. “It is a challenge to treat patients with hepatitis C virus infection, including the significant number of patients with genotype 3, whose condition tends to progress rapidly,” said Anna Maria Geretti, Professor of Virology and Infectious Diseases, University of Liverpool. “In the past there have been limited treatment options available and therefore this decision is an important milestone. Daclatasvir in combination with other agents represents a much needed oral treatment regimen that has been shown to cure the infection in the majority of patients, and we have already seen positive results in the real-life setting in patients with advanced disease.”
Castlight Health, Inc. (NYSE: CSLT), a leader in enterprise healthcare management (EHM), today announced that it has scheduled a conference call to review its third quarter 2015 results (ended September 30, 2015) for Wednesday, November 4, 2015 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). To listen to the conference call live, dial (877) 201-0168. The conference ID number is 57888376. Please dial in at least five minutes before the scheduled start time. A live webcast can be accessed at www.castlighthealth.com. A replay of the call will be available, beginning at approximately 4:30 p.m. Pacific Time on November 4, 2015 for one week, at (855) 859-2056, and archived via webcast at www.castlighthealth.com. The replay access code is 57897700. A press release highlighting the company's results will be issued in advance of the conference call and will be accessible at www.castlighthealth.com in the Investor Relations section.
Cerecor Inc. (NASDAQ: CERCU), a clinical-stage biopharmaceutical company with the goal of becoming a leader in the development of innovative drugs that make a difference in the lives of patients with neurological and psychiatric disorders, today announced the pricing of its initial public offering of 4,000,000 units at a public offering price of $6.50 per unit, before underwriting discounts and commissions. Each unit consists of one share of common stock, one Class A warrant to purchase one additional share of common stock and one Class B warrant to purchase one-half additional share of common stock. All of the units are being offered by Cerecor. In addition, Cerecor has granted to the underwriters a 45-day option to purchase up to an additional 600,000 units at the initial public offering price per unit, before underwriting discounts and commission. The units are expected to begin trading on The NASDAQ Capital Market today, October 15, 2015, under the ticker symbol “CERCU.” Maxim Group LLC is acting as sole book running manager for the offering. Laidlaw & Company (UK) Ltd. is acting as lead manager. The transaction is scheduled to close on October 20, 2015, subject to the terms and conditions of the underwriting agreement. On or prior to December 14, 2015, the units will separate into each of its components and each such component securities will begin trading separately. The common stock is expected to trade on The NASDAQ Capital Market under the symbol “CERC,” while the Class A warrants are expected to trade under the ticker symbol “CERCW” and the Class B warrants are expected to trade under the ticker symbol “CERCZ.” Cerecor will issue a press release announcing the date such separate trading will begin.
Cerulean Pharma Inc. (NASDAQ:CERU), a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced completion of enrollment of a randomized Phase 2 trial of its lead NDC, CRLX101, in combination with Avastin®, in third- and fourth-line relapsed renal cell carcinoma (RCC). The trial has enrolled all 110 patients and the company expects to announce top-line data in the first half of 2016. “This is an exciting time in the evolution of RCC treatments,” said Martin H. Voss, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center and Principal Investigator for the trial. “Currently approved treatment options provide limited benefit to heavily pretreated patients, and the therapeutic approach in the third- and fourth-line setting is poorly defined. There remains a clear need for a different mechanistic approach, so I am pleased that we have completed enrollment and look forward to the results.” “Completing enrollment in this Phase 2 trial marks a significant milestone for the company,” stated Christopher D. T. Guiffre, President & Chief Executive Officer of Cerulean. “We are grateful for the dedication demonstrated by the patients and the clinical investigators that are participating in this trial.”
eHealth, Inc. (NASDAQ: EHTH), which operates Medicare.com and eHealthMedicare.com, two of the nation's leading online marketplaces for private Medicare health insurance products, enters the 2016 Annual Election Period (AEP) with a wealth of tools and services to help seniors find the Medicare coverage that's right for them. Medicare's 2016 AEP begins October 15, 2015 and ends on December 7, 2015. During AEP, people eligible for Medicare can enroll in, or change their enrollment in, Medicare Advantage plans or Medicare Prescription Drug Plans. Changes made during this AEP become effective on January 1, 2016. "eHealth is excited about Medicare's Annual Election Period for 2016 because we've dramatically improved our ability to help people on Medicare get the coverage that's right for them," said Bill Shaughnessy, President and Chief Operating Officer of eHealth. "We've improved our technology at every touch-point, we've got a skilled, veteran customer support team, and we've added new products from brand-name insurance companies. I believe eHealth has made it easier than ever for a person on Medicare to comparison shop for plans over the phone, online, or both."
Extendicare Inc. (TSX: EXE) announced that it has declared a cash dividend of C$0.04 per common share of the Company (the "Common Share") for the month of October 2015, which is payable on November 16, 2015 to shareholders of record at the close of business on October 30, 2015. This dividend is designated as an "eligible dividend" within the meaning of the Income Tax Act (Canada). Extendicare has a Dividend Reinvestment Plan (the "DRIP"), which provides Canadian resident holders of Common Shares with the opportunity to increase their respective investments at a 3% discount to the volume weighted average trading price of the Common Shares on the TSX for the five trading days immediately preceding the dividend payment date. A copy of the DRIP package is available under the investors section of Extendicare's website.
Great Basin Scientific, Inc. (NASDAQ:GBSN), a molecular diagnostics company, today announced it added 28 new customers in the third quarter of 2015. As of September 30th, the company had secured 143 U.S. customers and had 64 evaluations either in-progress or scheduled, compared to 115 customers and 46 evaluations reported for the second quarter ending June 30, 2015, representing an increase of 24 percent and 39 percent respectively. Great Basin’s sales funnel, which represents the number of customers along with active and scheduled customer evaluations, grew to 207 at the end of the third quarter, up from 161 at the end of the second quarter, an increase of 28.5 percent. Adoption for Great Basin’s Group B Streptococcus (GBS) test—which was commercially launched on June 1, 2015—continued to expand. The Company ended the third quarter with 66 customers and potential customers either evaluating or scheduled to evaluate GBS, a 38.6 percent increase over the customer and potential customer sites for GBS reported at the end of second quarter. “September was the strongest month for customer acquisition in the history of Great Basin—with 24 new customers added in that month alone—showing what we believe is sustained strength in our sales funnel, and continuing demand for our Group B Strep test,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. “I’m extremely pleased with the strides we have made toward a shortened sales cycle and for achieving a 91 percent evaluation win-rate in the quarter, which adds to our confidence of achieving our customer acquisition guidance by the end of the year.”
GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to provide a corporate update and discuss the Company's third quarter 2015 financial results on Thursday, October 29, 2015 at 9:00 a.m. Eastern Time. The call and webcast will follow the release of the financial results earlier that day. To listen to the conference call, please dial: 877-930-8288 from the United States and Canada or 253-336-8703 (International), The passcode for the call is 58836318. A playback of the call will be available later in the day through November 5, 2015 and may be accessed by dialing: 855-859-2056 from the United States and Canada or 404-537-3406 (International), The passcode for the replay is 58836318. Additionally, a link to the live and subsequently archived webcast of the conference call may be found in the Investor Relations section of the Company's website at www.gtxinc.com.
Nurses Lounge, Inc., a wholly owned subsidiary of MedCareers Group, Inc. (OTC: MCGI), is pleased to announce that their recent addition of some of the most prestigious nursing schools to their professional network has brought significant interest from major health systems across the US. They have clearly begun to take notice of the continually growing supply side list and are discovering the many benefits of participating in a professional network just for nurses. Recent health systems that have activated an interactive lounge page in the network for their organizations include: Baptist Health System located in San Antonio, Texas; Christus Spohn Health System, in Corpus Christi, Texas; University of Tennessee Medical Center. Knoxville, TN; Dartmouth-Hitchcock Health in New Hampshire; Doctor's Hospital at Renaissance of Edinburg, Texas; Cone Health in Greensboro, North Carolina. "With a quick tour of the network, employers see how leading nursing schools are utilizing our network and how they can use our service to quickly increase their recruiting reach while simultaneously reducing time and costs. It's exciting to see that employers are embracing the network and not just from one geographic location, but from across the entire country. This really opens up the market and should have a very positive impact on the bottom-line sooner rather than later," said Timothy Armes, Company founder and CEO.
PharmaCyte Biotech’s (OTCQB: PMCB) advanced pancreatic cancer treatment of Cell-in-a-Box® capsules + low-doses of ifosfamide has outperformed Eli Lilly’s anti-cancer chemotherapy drug Gemzar® or gemcitabine in early phase clinical trials when compared to historical data for gemcitabine in 3 key areas: median survival time, one-year survivors and harmful side effects. PharmaCyte’s treatment also showed better data in those same 3 areas in early phase trials than Celgene’s Abraxane® plus gemcitabine, the current “gold standard,” offers patients. It now appears that the small Silver Spring, Maryland, biotech firm plans to live by the motto, if you can beat them, join them. This week PharmaCyte announced that it has redesigned its upcoming clinical trial in pancreatic cancer to address a critical unmet medical need. According to the company, the trial is designed to provide an effective treatment for the large percentage of patients who no longer respond to the “gold standard” for the treatment of advanced pancreatic cancer. PharmaCyte said that there are few options for further treatment available to those patients, and even those treatments are only marginally effective.
Ventripoint Diagnostics Ltd. (TSX VENTURE:VPT) announces that at its Annual General Meeting on October 13, 2015 the shareholders elected Dr. George Adams, Mr. Danny Dalla-Longa, Dr. Alan Rabinowitz and Mr. Treuman Katz as Directors of the Company. They further approved the Incentive Stock Option plan and gave authority to the Board of Directors to undertake a share consolidation if it deems the consolidation is in the best interests of Ventripoint. BDO was appointed as auditors of the Company for the next year. In addition, on September 30, 2015 the Company retained the services of Renmark Financial Communications Inc. ("Renmark") to handle its investor relations activities. "We are pleased to announce that we have selected Renmark to reinforce Ventripoint's profile in the financial community and enhance the visibility of our project portfolio. We chose Renmark because its standards and methodologies fit best with the message we wish to communicate to the investing public," noted Dr. George Adams, President and Chief Executive Officer of Ventripoint. Founded in 1999 by its sole owner, Mr. Henri Perron, Renmark is based in Montreal, Quebec and is a leading full-service investor relations firm representing publicly traded companies listed on all major North American stock exchanges.
ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced it is showcasing the new CoolMini™ applicator at the American Society of Dermatologic Surgery annual meeting in Chicago, October 15-18, and at Plastic Surgery The Meeting in Boston, October 16-20. The CoolMini applicator is designed to treat smaller pockets of fat, including the submental, or chin fat area, more commonly referred to as the double chin. The CoolSculpting® procedure is a noninvasive, clinically proven procedure designed to selectively reduce fat in treated areas using a patented cooling technology.