|CytRx Receives Written FDA Communication Regarding Partial Clinical Hold for Aldoxorubicin; Oncotype DX Predicts Outcomes In Prostate Cancer Patients|
|By Marilyn Mullen|
|Wednesday, 03 December 2014 20:13|
CytRx Corporation (NASDAQ: CYTR), announced that the Company has received written notice from the United States Food and Drug Administration (FDA) that its clinical trials for aldoxorubicin have been placed on partial clinical hold. The news supplements and is consistent with the prior verbal communications from the FDA.
As previously announced, all currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols, but no new patients can be enrolled until the clinical hold is lifted. At the FDA's request, the Company will amend all aldoxorubicin study protocols to include an appropriate inclusion/exclusion criteria, an additional patient screening assessment and an evaluation of serum electrolytes prior to aldoxorubicin administration. CytRx is working diligently in collaboration with the FDA to seek the release of the clinical hold and resume enrollment in its clinical studies.
CytRx currently believes that the partial hold issue will be expeditiously resolved and that enrollment rates and timelines for its ongoing trials will remain materially unchanged, subject to FDA timing. The Company currently expects to announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Kaposi's Sarcoma in the first half of 2015 and preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in glioblastoma multiforme in the first half of 2015. CytRx remains committed to completing enrollment of its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015.
Genomic Health, Inc. (NASDAQ:GHDX) announced results from two studies of the Oncotype DX® prostate cancer test demonstrating its value in low- and intermediate-risk prostate cancer to enable physicians and patients to avoid over- and under-treatment of the disease. Both studies will be presented today, December 3, at the Society of Urologic Oncology (SUO) Annual Meeting, in Bethesda, Md.
Results from the latest clinical validation study, published in European Urology this month online, show that the Oncotype DX test predicts near- and longer-term outcomes in a racially diverse group of men with clinically localized prostate cancer. The analyses, conducted in collaboration with the Uniformed Services University of the Health Sciences' Center for Prostate Disease Research (CPDR), reconfirmed the biopsy-based Oncotype DX prostate cancer test as a predictor of whether adverse pathology would be found if the prostate were removed by surgery. Additionally, for the first time, the Oncotype DX prostate cancer test was validated as a strong independent predictor of biochemical recurrence, which is a rise in PSA following surgery. Furthermore, the study, in which 20 percent of patients were African-American men, demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men.
"Our recently conducted survey of African-American men showed that more than 70 percent think prostate cancer is best treated immediately and that their loved ones would want them to do so," said Thomas A. Farrington, founder and president of the Prostate Health Education Network (PHEN). "These statistics highlight a significant potential for prostate cancer over-treatment and underscore the need for more knowledge about genomic tests like Oncotype DX, which provides a scientifically precise assessment of each patient's prostate cancer aggressiveness, and can help relieve the anxiety experienced by men and their families in making the proper treatment decision."
"Each year, 240,000 men are diagnosed with prostate cancer in the Unites States alone. Importantly, more than half of these men have low-risk disease and can be candidates for active surveillance," said Phil Febbo, M.D., chief medical officer, Genomic Health. "With eleven prostate cancer studies in more than 1,500 patients, Genomic Health has developed and validated the only genomic test that has met the most actionable endpoint of adverse pathology, giving physicians the confidence to put many low- to intermediate-risk patients on active surveillance, while identifying those patients who might be missed by conventional measures and could benefit from more aggressive treatment."
Separately, the results of the first Oncotype DX prostate cancer test decision impact study showed that the use of the test significantly changed treatment recommendations. Conducted in collaboration with academic and community practices at Columbia University, Delaware Valley Urology and Orange County Urology, this prospective study in a contemporary population of men with low- or intermediate-risk disease showed that the use of the test substantially increased the number of men who would be eligible for active surveillance. Additionally, use of the test increased physician confidence in their treatment recommendations.
"Prostate cancer comes in many different forms and having confidence in your treatment recommendation and decision is crucial," said Ketan K. Badani, M.D., lead investigator of the study and vice chairman of Urology and Robotic Operations at Mount Sinai Health System, New York. "Nearly half of prostate cancer is not aggressive and now we have more advanced tools like genomic profiling with the Oncotype DX test to determine a man's individual risk."
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced its lead product candidate RI-002 has demonstrated positive Phase III results and successfully achieved its primary endpoint.
Arem Pacific Corporation (OTC:ARPC) today announced the appointment of Mr. Kenneth (Kin Chiu) Leung as the company's new director and VP of Mergers & Acquisitions.
Arem Pacific Corporation (OTC:ARPC) today announced it has retained a well-known audit firm, Shinewing Hall Chadwick, in Melbourne, Australia, to do the required SEC audit work to register more stock for general trading. AREM will work with its legal team in the US to accomplish this goal as soon as practicable.
Assembly Biosciences, Inc. (Nasdaq:ASMB) today announced that it is participating in two investor conferences this week. The company has been invited to join a Hepatitis B Virus panel at the 26th Annual Piper Jaffray Healthcare Conference being held at The New York Palace in New York City.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile tools for medical groups and health systems, today announced that Granite Healthcare Network (GHN) has selected athenahealth's cloud-based athenaCoordinator® Enterprise Population Manager to improve care quality and coordination across GHN's growing network of risk-based payment arrangements, which now includes over 80,000 lives.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in Circulating Tumor Cells (CTCs) and Circulating Tumor DNA (ctDNA) biomarker analysis, today announced that Veena Singh, MD, FCAP, FCAMG has joined the Company as Senior Vice President and Senior Medical Director.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) will host an Analyst & Investor Day for the investment community on Wednesday, December 10, 2014 from 8:00am to 1:00pm Eastern Time.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today the addition of Howard McLeod, Pharm. D., and Geoffrey Harris to the Company's Board of Directors.
CollabRx, Inc. (Nasdaq:CLRX), announced today that it received a letter from the NASDAQ OMX GROUP ("Nasdaq") stating that the Company is in non-compliance with the Nasdaq Capital Market's Listing Rule 5550(b)(1).
Cryo-Cell International, Inc. (OTCQB:CCEL), the world's first company to offer cord blood banking services, announced today that its Board of Directors (the "Board") has unanimously adopted a three-year stockholder rights plan (the "Plan"), effective December 5, 2014, and declared a dividend distribution of one preferred share purchase right on each outstanding share of the Company's common stock, as well as certain other shares that become outstanding, such as upon the exercise of stock options or conversion or exchange of securities or notes.
Elite Pharmaceuticals, Inc. (OTCBB:ELTP) announced today successful results from a pivotal bioequivalence (BE) study for ELI-201, Elite's twice daily abuse-deterrent oxycodone product which utilizes Elite's proprietary pharmacological abuse-deterrent technology.
LHC Group, Inc. (Nasdaq:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that Keith G. Myers, chief executive officer of LHC Group, will present at the Oppenheimer 25th Annual Healthcare Conference in New York City, on Thursday, December 11, 2014.
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced that Christopher M. Cashman, Chairman and Chief Executive Officer of Marinus, will present at the 2014 Oppenheimer Healthcare Conference on Thursday, December 11, 2014 at 9:10 a.m. ET.
Medical Marijuana, Inc. (OTC Pink:MJNA), a leading cannabis and industrial hemp industry innovator, is proud to announce that its joint venture company, CanChew Biotechnologies, LLC (CanChew®), was honored by HealthyLivinG Foundation with its Triple Leaf Award. CanChew®, a hemp cannabidiol (CBD) oil-infused chewing gum, is also featured in Healthy Living Magazine's December issue reaching its more than 835,000 readers and social media followers.
MergeWorthRx Corp. (Nasdaq:MWRX) announced today that it has set a record date of December 9, 2014 and a meeting date of December 22, 2014 for the special meeting in lieu of the 2014 annual meeting of stockholders of the Company (the "Special Meeting") relating to the previously announced proposed business combination (the "Business Combination") between the Company and AeroCare Holdings, Inc. ("AeroCare").
Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical-stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced the appointment of Michael Byrnes as chief financial officer.
Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that John A. Orwin, president and chief executive officer, will present at the Oppenheimer 25th Annual Healthcare Conference on December 10, 2014 at 9:45 a.m. ET.
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, announced today the appointment of Richard Rodgers to the company's Board of Directors.
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Tom Kassberg, the company's Chief Business Officer, will be presenting at the Oppenheimer 25th Annual Healthcare Conference on December 10, 2014 at 9:10am ET in New York.
VitaCig®, Inc. (OTCQB: Pending Stock Symbol), a technology company that owns, manufactures, and distributes the VitaCig® products, is pleased to announce the official appointment of Alfred Santos as Chief Executive Officer of VitaCig Inc. in preparation for its public listing.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today announced the presentation of clinical and preclinical studies from their immuno-oncology programs at the American Association for Cancer Research (AACR) 2014 Immunology and Immunotherapy Meeting taking place December 1-4, 2014 in Orlando, Florida. Presentations include: Clinical results from the Ad-RTS-hIL-12 + veledimex studies in patients with advanced breast cancer and melanoma demonstrating local and systemic IL-12-mediated anti-cancer activity, as well as safety through control of both immune- and IL-12-mediated toxicity with use of the RheoSwitch Therapeutic System® (RTS®) gene switch (Abstract #B11); Preclinical data supporting the potential for cytolytic activity against solid tumor targets with allogeneic, genetically-modified stem cells enabled for controlled release of cell-linking moieties (CLMs) within the tumor micro-environment (Abstract #B25); and Preclinical data describing the development of a novel, high-throughput screening technology for rapidly identifying bi-specific antibodies capable of inducing targeted immunologic activity through the activation of T-cells or other immune cells against tumors (Abstract #B16).