TherapeuticsMD Announces Presentation Of Positive Phase 2 On TX-004HR; Advaxis Provides Clinical Update For ADXS-HPV Print E-mail
By William Kent   
Wednesday, 15 October 2014 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 15, 2014.
TherapeuticsMD Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, announced positive results from phase 2 and pharmacokinetic studies of TX-004HR will be presented at the 25th Annual Meeting of The North American Menopause Society, October 15-18, 2014, at the Gaylord National Resort & Convention Center in Washington, D.C.

James H. Pickar, M.D., FACOG, adjunct associate professor of obstetrics and gynecology at Columbia University College of Physicians & Surgeons in New York City, will make the first scientific presentation of a phase 2 pilot safety and efficacy study and pharmacokinetic studies on investigational compound TX-004HR. His oral presentation, “Pilot and Pharmacokinetic Studies of Solubilized Estradiol Administered Vaginally in a Softgel Capsule,” is scheduled for Thursday, October 16 from 4:30-4:45 p.m.

These results “…provide promising news for women who may potentially benefit from a low-dose, locally administered hormone treatment option for relief from the pain and discomfort of menopause-associated vulvar and

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vaginal symptoms,” Pickar said.

Vulvar and vaginal atrophy (VVA) is a condition resulting from the decrease in naturally occurring estrogen during menopause, resulting in thinning of the vaginal lining and
an increase in vaginal pH levels. Although an estimated 32 million women in the United States are currently suffering from symptoms of VVA, only 2.3 million (7 percent) are currently being treated with prescription therapy.†

TherapeuticsMD's phase 3 Rejoice Trial for this drug candidate began in September 2014 and is investigating 4 mcg, 10 mcg and 25 mcg estradiol doses. The investigational compound TX-004HR 4 mcg dose represents a potentially new low dose local estrogen treatment.


 
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Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced preliminary data from its Phase 1/2 study of ADXS-HPV in human papillomavirus (HPV) associated anal cancer that indicate a "clinical complete response" in all 7 patients who have completed the treatment regimen.

"We are pleased with this preliminary data," commented Dr. Howard Safran, Medical Director of Brown University Oncology Research Group (BrUOG) and principal investigator of the study. "We are now in the process of opening this study at other institutions."

Conducted by BrUOG, the Phase 1/2 trial is a non-randomized, open-label, multi-center study of 25 patients designed to determine the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer in patients who have a high risk of recurrence based on their disease. The primary efficacy objective of the study is to assess the proportion of patients maintaining a clinical complete response at the 6 month mark. Based on historical clinical experience in similar high risk patients and pursuant to the study protocol, the addition of ADXS-HPV will be considered promising if the 6 month complete response rate is greater than 80%.

At present, 7 of 8 patients out of the planned total accrual of 25 patients have completed the treatment regimen. The 7 patients are without evidence of disease. Preliminary safety findings indicate flu-like symptoms were the most common adverse reaction lasting for about 24 hours.

Patients have been treated at Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). With these results, the study is being expanded to Ohio State University and Rutgers University, and these sites are in the process of activation.

Daniel J. O'Connor, President and CEO of Advaxis, remarked, "Though we recognize that the data is preliminary, it suggests a positive therapeutic response in the treated patients that warrants further investigation. Our strategy is to provide an immunotherapeutic treatment option to patients with HPV-associated anal, cervical and head & neck cancer - each of which Advaxis has obtained orphan drug status."


 
Also Wednesday:



Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced preliminary data from its Phase 1/2 study of ADXS-HPV in human papillomavirus (HPV) associated anal cancer that indicate a "clinical complete response" in all 7 patients who have completed the treatment regimen.

Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced the initiation of four expansion cohorts in its ongoing Phase 1 study of AG-221, a first-in-class, selective, potent IDH2 mutant inhibitor.

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global medical device company that provides spinal fusion technology solutions for patients with spinal disorders, will release its third quarter 2014 financial results on Thursday, October 30, 2014, after the close of the market.

BioMed Realty Trust, Inc. (NYSE:BMR) today announced it will report results for its third quarter ended September 30, 2014 after the market closes on Wednesday, October 29, 2014.

Cellectar Biosciences, Inc. (Nasdaq:CLRB), announced that an article reporting the efficacy of its proprietary phospholipid ether (PLE) analog agents for the detection, imaging and real-time visualization of colorectal cancer was published in PLOS ONE, an international, peer-reviewed publication.

Cytomedix (OTCQX:CMXI), a pioneer in biodynamic therapies, today announced that it will introduce its chronic wound care system, AurixTM, during the Symposium on Advanced Wound Care (SAWC) Fall Meeting, being held October 16-18, 2014 in Las Vegas, Nevada. Cytomedix will be presenting the Aurix System™ at the Company's exhibition booth (#511).

Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced today that the Jesse Brown VA Medical Center in Chicago has ordered three Ekso GT™ robotic exoskeletons for use in general neuro-rehabilitation of patients with stroke, traumatic brain injury, and incomplete spinal cord injury.

ExamWorks Group, Inc. (NYSE:EXAM) announced today that the Company will release third quarter 2014 earnings on Tuesday, November 4th after the market close.

LipoScience, Inc. (Nasdaq:LPDX) today announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 applicable to the acquisition of LipoScience by Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH).

Medgenics, Inc. (NYSE:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of orphan diseases, today released initial positive clinical data from the clinical study of MDGN-201, as well as third quarter financial results.

MergeWorthRx Corp. (Nasdaq:MWRX), a special purpose acquisition company focused on the U.S. healthcare services market, and privately-held AeroCare Holdings, Inc. (AeroCare), a national leader in home respiratory therapy services with annual revenue of approximately $150 million, announced today that they have signed a definitive merger agreement pursuant to which AeroCare will become a publicly traded company through an all-stock merger with MergeWorthRx.

Mesa Laboratories, Inc. (Nasdaq:MLAB) today announced the acquisition of substantially all of the assets and certain liabilities of the process challenge device business (the "PCD Business") from PCD – Process Challenge Devices, LLC, a California company ("PCD-LLC").

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB) announces its intention to repurchase parts of its class A common shares (the "common shares") issued and outstanding by way of a normal course issuer bid ("NCIB") to be carried out by TD Securities Inc. through the facilities of the Toronto Stock Exchange ("TSX") and Nasdaq Stock Market ("Nasdaq"), in accordance with applicable Canadian and U.S. regulatory requirements and TSX rules, based on which Neptune may be allowed to repurchase up to the higher of 5% of its common shares issued and outstanding or 10% of its Public Float (as such term is defined under the TSX Policies).

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that its RSV F-protein nanoparticle vaccine candidate (RSV F Vaccine) evoked a polyclonal antibody response to antigenic site II, the same site targeted by the monoclonal antibody palivizumab (Synagis®), resulting in protection from an RSV challenge in an animal model.

Pacific Biosciences of California, Inc., (Nasdaq:PACB) provider of the PacBio® RS II DNA Sequencing System, today announced the release of new chemistry and software designed to enhance the performance and output of the platform by 45%.

Protea Biosciences Group, Inc. (OTCQB:PRGB)
announced today that Princeton University has purchased Protea's LAESI DP-1000 Instrument System for direct molecular analysis.

SmallCapVoice.com, Inc. (SCV) announced today that a new audio interview with Southern Home Medical, Inc. (OTC Pink:SHOM), is now available.

Tauriga Sciences, Inc. (OTCQB:TAUG), a diversified life sciences company with interests in the natural wellness sector and in developing a proprietary synthetic biology platform technology, today announced that the Company is completely free of convertible debt for the first time since the fiscal fourth quarter of 2012.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, announced today the presentation of preclinical results characterizing TKM-HBV, a therapeutic agent targeting human hepatitis B virus (HBV), at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society.

TriVascular Technologies, Inc. (Nasdaq:TRIV) announced today that the U.S. Food and Drug Administration (FDA) has approved CustomSeal Technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customized seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo.

VeriTeQ Corporation (OTC Markets:VTEQ)
, a provider of implantable medical device identification and radiation dose measurement technologies, announced today that the Company and its breast implant customer, Establishment Labs, S.A., ("EL") are hosting a physician conference in Salzburg, Austria on October 16, 2014, based on demand for EL's Motiva Implant Matrix® breast implants with VeriTeQ's Q Inside Safety Technology™.



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