Apr 14, 2016

Posted by in Biotech Stocks | 0 Comments

Notable Runners: Repros Therapeutics Inc (NASDAQ:RPRX), Stem Cells Inc (NASDAQ:STEM), Intrexon Corp (NYSE:XON)

Notable Runners: Repros Therapeutics Inc (NASDAQ:RPRX), Stem Cells Inc (NASDAQ:STEM), Intrexon Corp (NYSE:XON)

Repros Therapeutics Inc (NASDAQ:RPRX) stock is at $2.25, up +175.40 percent from its previous close of $0.82. The stock opened the session at $1.18 and touched its highest price point at $2.25. The company’s stock’s lowest price point for the session stood at $0.97. Its yesterday’s volume was 28.57 million shares in comparison to its usual trading volume of 138,894.00 shares.

Repros Therapeutics Inc (NASDAQ:RPRX) on April 12, 2016 reported that vaginal administration of Proellex® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.

Normal menstrual blood loss in a menstrual cycle is approximately 35 mL. Woman experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this small Phase 2b study, 13, 15 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and placebo arms, respectively. At baseline, the mean amount of blood lost for one menstrual cycle was 255 mL, 274 mL and 238 mL for each arm, respectively. The blood loss ranged from a low of 94 mL to a high of 654 mL. The most severe menstrual bleeding at baseline was observed in the 12 mg group. Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.

When a sufficient concentration of Proellex® is achieved in circulation, amenorrhea (cessation of menses) is achieved. Just over half, 52%, of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. All subjects treated with Placebo continued to menstruate throughout the 18 week dosing period. The p-value for this comparison is 0.0011.  Bleeding diaries consistently report a statistically significant difference in the number of days of bleeding and bleeding intensity between those treated with Proellex® and Placebo.

Bleeding was also evaluated by PBAC (Pictorial Blood Assessment Chart).  Subjects tallied sanitary product usage and stain size as guided by the chart.  Proellex®-treated subjects reported a median 100% reduction in PBAC scores while Placebo-treated subjects reported a 25.4% reduction, further supporting the treatment affect associated with bleeding (p=0.0033).

Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex®-treated arms by 18% while the Placebo group showed continued increase in size, p= 0.0437.

Stem Cells Inc (NASDAQ:STEM) stock is at $0.230, down -1.75 percent from its previous close. Its yesterday’s volume is 1.52 million shares in comparison to its usual trading volume of 1.84 million shares. Previous 5 days graph demonstrated a negative move of -4.76%. Its quarterly performance remained red with the percentage of -30.97, while its year to date performance showed that the stock plunged overall -48.3%.

Stem Cells Inc (NASDAQ:STEM) on March 30, 2016 announced the company’s ongoing Phase II Pathway™ Study in cervical spinal cord injury (SCI) was featured in an article published in The Downey Patriot.

For the story entitled “Rancho Los Amigos partners with USC for groundbreaking stem cell research,” Christian Brown spoke with Dr. Charles Liu, Associate Chief Medical Officer and Chair of Neurosurgery and Spine at Rancho Los Amigos National Rehabilitation Center in Downey, Ca., and Principal Investigator of the trial, and Dr. Stephen Huhn, Vice President of Clinical Research and Chief Medical Officer at StemCells, Inc.

The Phase II Pathway Study, titled “Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury,” will evaluate the safety and efficacy of transplanting the Company’s proprietary human neural stem cells (HuCNS-SC® cells) into patients with traumatic injury in the cervical region of the spinal cord. Conducted as a randomized, controlled, single-blinded study, the trial will measure efficacy by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms and shoulders. The trial will enroll approximately 52 subjects in three cohorts.  Enrollment in the first cohort of six subjects has been completed.  The Company is actively enrolling 40 patients in cohort II.

Intrexon Corp (NYSE:XON) traded in the range of $33.31 and $36.10 in its previous trading session. The stock recorded the volume of 2.17 million shares so far, in comparison its average daily trading volume of 1.71 million shares. Company’s year to date performance remained quiet optimistic with the rise of 13.3%. The stock opened at $34.29 and its closing price for the day was $35.59, up +7.82 percent from its previous close.

Intrexon Corp (NYSE:XON) on April 13, 2016 announced it has entered into Exclusive Channel Collaborations (ECC) with two startups backed by the Harvest Intrexon Enterprise Fund, sponsored by Harvest Capital Strategies, LLC.  Through the proprietary technologies of Intrexon, these companies will pursue new approaches for unmet needs in human health:

  • Relieve Genetics, Inc. will focus on a breakthrough, non-opioid gene therapy approach for neuropathic pain; and
  • Exotech Bio, Inc. will utilize a novel exosome-based platform for delivering therapeutic RNA to treat select cancer indications.

“We are excited to enter into these new collaborations within Intrexon’s Health Sector to advance medicine on multiple fronts,” said Samuel Broder, M.D., Senior Vice President, Head of Intrexon’s Health Sector.  “Neuropathic pain is a tremendous unmet need in healthcare today.  The collaboration with Relieve Genetics offers a significant opportunity to materially impact the lives of many patients who are in desperate need of relief from pain refractory to other therapies including opiates.”

Neuropathic pain is a common, chronic complication caused by a number of different medical conditions.  Current standard of care focuses mainly on easing discomfort as treatments are limited by incomplete efficacy and dose-limiting side-effects.  Relieve Genetics, Inc. will instead center its therapeutic efforts on the underlying pathophysiology of neuropathic pain through gene therapy.  With a designed viral vector delivery system, the collaboration will target delivery of an immunomodulatory protein alone or in combination with multiple therapeutic effectors under the control of the RheoSwitch Therapeutic System®, providing localized, persistent, and regulatable drug delivery for pain management.

 

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