Clinical Studies Elevating Biotech Drug Development to New Levels for Unmet Medical Needs

Tuesday, November 7, 2017 Drug News
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PALM BEACH, Florida, November 7, 2017 /PRNewswire/ --


to bring new drug developments to the market through highly regarded and respected clinical research and studies are of a continued result of ongoing collaborations with academic and medical researchers allowing innovative biotech companies to provide
revolutionary therapies as well as new advance medicines and treatment options for patients with unmet medical needs. The latest clinical studies for identifying exciting new therapies to address important unmet medical needs are fueling advancements in the drug development and accelerated regulatory review processes. Active biotechs in the markets today include: Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Vascular Bioegenics Ltd. (NASDAQ: VBLT), OncoSec Medical Incorporated (NASDAQ: ONCS), TherapeuticsMD Inc. (NASDAQ: TXMD) and Cara Therapeutics Inc. (NASDAQ: CARA).

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Breaking News: International Study at MD Anderson Sister Institutions Supports Mino Lok™ Phase 2b Results: Poster Presented at ID Week - Results showed a 95% efficacy in salvaging infected catheters for Mino-Lok ™ - Citius Pharmaceuticals, a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced that international data on Mino Lok™ was recently presented at the ID Week Conference in San Diego, California. Read this and more news for CTXR at: The 44 patient study, was conducted in Brazil, Lebanon, and Japan and showed Mino Lok™ therapy was an effective intervention to salvage long term, infected central venous catheters (CVCs) in catheter related bloodstream infections in patients who had cancer with limited vascular access. The poster was recently presented at the IDSA (Infectious Disease Society of America) meeting showed 95% effectiveness for Mino-Lok therapy in achieving microbiological eradication of the CVCs as compared to 83% for the control. Citius Chief Executive Officer, Mr. Myron Holubiak, commented, "it is extremely reassuring to note that Mino-Lok is as useful in clinics outside of the US as it is here in the number 1 rated cancer center. We are excited to advance this innovative product to a potentially greater than $1billion marketplace worldwide. We are beginning our phase 3 trials here in the U.S., and look forward to introducing Mino-Lok throughout the world." The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report's 'Best Hospital's' survey. It has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years.

In other biotech developments:

Vascular Bioegenics Ltd. (NASDAQ: VBLT) closed up over 4% on Monday at $6.45 with over 1.3 million shares traded by the market close. The company also announced an exclusive license agreement with NanoCarrier Co., Ltd. (TSE Mothers: 4571) for the development, commercialization, and supply of ofranergene obadenovec ("VB-111") in Japan. VBL Therapeutics (VBLT) retains rights to VB-111 in the rest of the world. "Japan is potentially a large market opportunity for VBLT, and this agreement provides us with access into this important market as we continue to prepare for commercialization of VB-111 in recurrent glioblastoma (rGBM), and in other indications," said Dror Harats, M.D., chief executive officer of VBL Therapeutics. "We see this agreement with NanoCarrier as providing further validation of the potential of VB-111 and we look forward to working together to bring this important anticancer therapy to patients and health care professionals in Japan."

OncoSec Medical Incorporated (NASDAQ: ONCS) recently announced updated Phase 2 clinical and immune monitoring data from patients treated with its investigational therapy, ImmunoPulse® IL-12 as a monotherapy versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab. These data were presented today in an oral presentation at the 2017 9th World Congress of Melanoma - A Joint Meeting with the Society for Melanoma Research, and continue to support the rationale for the Company's recently initiated global, open-label, Phase 2b registration directed trial, PISCES/KEYNOTE-695. The Phase 2 OMS-I100 monotherapy and Phase 2 OMS-I102 combination with pembrolizumab studies included 51 and 22* patients, respectively, with metastatic melanoma.

TherapeuticsMD Inc. (NASDAQ: TXMD) closed up over 31% on Monday at $5.74 trading over 31.6 million shares by the market close and was also up in afterhours trading. Recently TherapeuticsMD announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR, the Company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.  On November 3, 2017, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study.

Cara Therapeutics Inc. (NASDAQ: CARA) a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting peripheral kappa opioid receptors, recently announced the presentation of a late-breaking CR845 poster at the American College of Rheumatology ACR/ARHP Annual Meeting, to be held November 3-8, 2017 in San Diego. The poster presentation will include clinical trial data from the Company's completed Phase 2b study of Oral CR845 in patients with osteoarthritis of the hip or knee. CR845 is Cara's first-in-class, peripherally selective kappa opioid receptor agonist being developed for the treatment of acute and chronic pain, as well as chronic kidney disease-associated pruritus.

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