|Repros Initiates Two Phase 2B Uterine Fibroid Studies; Intersect ENT Announces Enrollment of First Patient in Phase III Study|
|By Marilyn Mullen|
|Monday, 29 December 2014 20:08|
Repros Therapeutics Inc.® (NASDAQ: RPRX) announced it has initiated two Phase 2B efficacy studies of Proellex® in the treatment of uterine fibroids in women that experience heavy vaginal bleeding as a result of these benign tumors. The two studies both have the same FDA suggested endpoints but test two different routes of administration, oral and vaginal. The Company had previously tested both routes using similar doses and found that Proellex® exhibited significant effects on bleeding due to uterine fibroids with each route of administration.
In addition to significant effects on bleeding due to Proellex® administration, tumor size was significantly reduced. As a result of reduced tumor burden, bulk symptoms improved to the point where the majority of subjects reported to be symptom free using the Uterine Fibroid Symptom Quality of Life survey (UFSQoL). The UFSQoL is a validated survey that was used to approve uterine artery embolization and ultrasound focusing.
In earlier Phase 2 studies, both oral and vaginal administration of Proellex® stopped menses and hence, in this study, on recommendation from the FDA, Repros has chosen amenorrhea as the primary efficacy endpoint. The studies both have three double blind arms: placebo and Proellex® at 6 mg and 12 mg doses. The two studies are powered to achieve the desired impact on menstrual bleeding with only 15 subjects per arm. In addition to investigating the incidence of amenorrhea, actual menstrual blood loss will be estimated by the alkaline hematin method from used sanitary products.
The studies are designed to treat women for two 4-month dosing courses separated by an off drug interval to allow for menses. Following the second course, the FDA instructed the Company to follow the women for six additional menstrual events to investigate the duration of benefit.
The Company plans to request a Type C meeting after all the subjects have experienced the menstrual event following the first course of treatment. An interim assessment of efficacy and safety is part of the analysis plan. Assuming enrollment proceeds according to plan, the Company believes it can schedule a Type C meeting with the FDA around year end 2015. The purpose of this meeting will be to discuss the overall FDA proposed size of the safety database required for an NDA.
Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced initiation of RESOLVE II, a pivotal Phase III clinical study to support U.S. Food and Drug Administration (FDA) approval of the company's RESOLVE steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.
RESOLVE II is the final planned clinical trial of the RESOLVE steroid releasing implant, which is designed to provide an in-office treatment for patients who continue to suffer from chronic sinusitis despite previous sinus surgery. Current treatment options for these patients may include repeat surgery or systemic steroids. The RESOLVE bioabsorbable drug-eluting implant is placed in the ethmoid sinuses to provide an immediate opening of the sinus and reduce inflammation and polyps by releasing steroid locally for approximately three months.
The current study will enroll 300 patients at up to 45 U.S. centers. Robert Kern, M.D., of Northwestern University in Chicago, Ill. and Pablo Stolovitzky, M.D., of ENT of Georgia in Atlanta, Ga., serve as co-principal investigators of the study. Primary study endpoints include assessment of improvements through both patient-reported symptoms and objective endoscopic outcomes as determined by clinical investigators and by an independent panel of surgeons.
"For many patients, the chronic nature of the disease often results in recurrent symptoms requiring multiple surgeries and courses of oral steroids, which have been associated with possible detrimental side effects," said Dr. Stolovitzky. "The RESOLVE in-office treatment has the potential to make a significant impact on patients' quality of life and cost of care by reducing the need for revision surgeries. The RESOLVE II trial is designed to gather additional evidence of the safety and efficacy of the implant in the largest group of patients studied to date."
"This study caps an exciting year for Intersect ENT. We are pleased to take another step forward in bringing another option to physicians and patients in the treatment of chronic sinusitis," said Lisa Earnhardt, president and CEO, Intersect ENT.
The RESOLVE II study builds on the company's recently completed RESOLVE clinical study. Similar in design, RESOLVE was a prospective, randomized, blinded, multi-center clinical trial that enrolled 100 patients. RESOLVE was designed to inform the design of the RESOLVE II study and provide safety and efficacy data to support the New Drug Application (NDA).
Like the company's commercially available PROPEL® and PROPEL® mini implants used to improve surgical outcomes following sinus surgery, the investigational RESOLVE product releases mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining to reduce inflammation. The RESOLVE product has more radial strength than the PROPEL products in order to dilate the obstructed sinus, and releases the steroid over a longer period of time.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced it will be presenting a corporate overview including top-line results of its expanded LP-002 study of the Lymphocyte Proliferation Test (LymPro Test®) blood diagnostic for Alzheimer's disease (AD) at Biotech Showcase 2015.
AMAG Pharmaceuticals (Nasdaq:AMAG) and Takeda Pharmaceutical Company Limited (Takeda) announced today that they have entered into an agreement to mutually terminate the March 2010 license, development and commercialization agreement, which granted Takeda exclusive rights to market ferumoxytol in Canada, the European Union (EU) and Switzerland, as well as certain other geographic territories (under the trade name Rienso® outside of Canada where the product's trade name is Feraheme®).
Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys' MultiStem® cell therapy to ischemic stroke patients.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the Ministry of Health, Labor and Welfare granted approval of the registration of VIMIZIM® (elosulfase alfa) for the treatment of patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome.
BSD Medical Corporation (Nasdaq:BSDM), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced that BSD's new CEO, Clint Carnell, will host an Investor & Analyst Update Call outlining BSD's three year strategic vision on Thursday, January 15, 2015 at 2:00 p.m. Eastern time/12:00 p.m. Mountain time.
CB Pharma Acquisition Corp. (Nasdaq:CNLMU), a Cayman Islands exempted company formed as a blank check company for the purpose of entering into a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization or similar business combination with one or more businesses or entities, announced in connection with the Company's public offering of 4,000,000 units, it has completed the sale of an additional 200,000 units pursuant to the 45-day over-allotment option granted to the underwriters in its public offering to purchase up to an additional 600,000 units.
Coronado Biosciences, Inc. (Nasdaq:CNDO), founder of CB Pharma Acquisition Corp., announced in connection with CB Pharma Acquisition Corp.'s public offering of 4,000,000 units, it has completed the sale of an additional 200,000 units pursuant to the 45-day over-allotment option granted to the underwriters in its public offering to purchase up to an additional 600,000 units. The issuance of the additional 200,000 units closed on December 24, 2014.
Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced initiation of RESOLVE II, a pivotal Phase III clinical study to support U.S. Food and Drug Administration (FDA) approval of the company's RESOLVE steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.
Landec Corporation (Nasdaq:LNDC), a leading developer and marketer of innovative and proprietary products for healthy living applications in the food and biomedical markets, has been invited to present at the Sidoti & Company Emerging Growth Institutional Investor Forum being held on Monday, January 12, 2015 at The Grand Hyatt Hotel in New York City.
Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ), the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, announced today that its President and Chief Executive Officer,
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced a federal judge in Texas has issued a definitive ruling finding correct inventorship for two Repros Therapeutics Androxal® patents, thus confirming that Repros Therapeutics is the sole and rightful owner of the patents, U.S. Patent No. 7,759,360 (the "'360 patent") and U.S. Patent No. 7,737,185 (the "'185 patent").
Repros Therapeutics Inc.® (Nasdaq:RPRX) today updated the regulatory status for its drug, Androxal®. Androxal® is an oral therapy for the treatment of low testosterone due to secondary hypogonadism.
Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has initiated two Phase 2B efficacy studies of Proellex® in the treatment of uterine fibroids in women that experience heavy vaginal bleeding as a result of these benign tumors. The two studies both have the same FDA suggested endpoints but test two different routes of administration, oral and vaginal.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that its management will be presenting at the J.P. Morgan 33rd Annual Healthcare Conference on January 14, 2015 in San Francisco.
Stemline Therapeutics, Inc. (Nasdaq:STML), announced today that it will present at the 33rd Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2015 at 10:00 AM PT (1 PM ET).
Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company developing a novel, long-acting form of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD), today announced it will hold a conference call and webcast on Monday, January 5, 2015 at 8:30 a.m. ET (5:30 a.m. PT).
Xerium Technologies, Inc. (NYSE:XRM), a leading global provider of industrial consumable products and services, recently was honored by Triangle Business Journal as one of the top 35 Healthiest Employers for 2014.