Genervon Announces Biomarker Data from GALS-001 Clinical Trial for ALS

first_imgCompany News Briefs Genervon Announces Biomarker Data from GALS-001 Clinical Trial for ALS From STAFF REPORTS Published on Monday, June 30, 2014 | 1:18 pm Make a comment Get our daily Pasadena newspaper in your email box. Free.Get all the latest Pasadena news, more than 10 fresh stories daily, 7 days a week at 7 a.m. 5 recommended0 commentsShareShareTweetSharePin it faithfernandez More » ShareTweetShare on Google+Pin on PinterestSend with WhatsApp,Virtual Schools PasadenaHomes Solve Community/Gov/Pub SafetyPASADENA EVENTS & ACTIVITIES CALENDARClick here for Movie Showtimes Subscribe Pasadena Will Allow Vaccinated People to Go Without Masks in Most Settings Starting on Tuesday HerbeautyHere Is What Scientists Say Will Happen When You Eat AvocadosHerbeautyHerbeautyHerbeauty5 Things To Avoid If You Want To Have Whiter TeethHerbeautyHerbeautyHerbeautyA Mental Health Chatbot Which Helps People With DepressionHerbeautyHerbeautyHerbeauty15 Beauty Secrets Only Indian Women KnowHerbeautyHerbeautyHerbeautyWhat Is It That Actually Makes French Women So Admirable?HerbeautyHerbeautyHerbeautyKeep Your Skin Flawless With These Indian Beauty RemediesHerbeautyHerbeauty Business News EVENTS & ENTERTAINMENT | FOOD & DRINK | THE ARTS | REAL ESTATE | HOME & GARDEN | WELLNESS | SOCIAL SCENE | GETAWAYS | PARENTS & KIDS More Cool Stuffcenter_img First Heatwave Expected Next Week today announced that it has analyzed and generated a Biomarker Data Report for its recent Phase 2a clinical trial for ALS disease modification. A full analysis of the trial’s results is expected to be completed in the third quarter of 2014, but preliminary clinical data and this biomarker data suggest that GM604—Genervon’s novel, proprietary, multi-target biological drug candidate—shows significant promise for treating ALS.Of the eight biomarkers measured in the trial, GM604 modulated six in a manner that suggests disease modification: one “target” biomarker, two “efficacy” biomarkers, two “target/efficacy” biomarkers, and one “prognostic” biomarker. Despite the small size of the trial (twelve patients, of whom eight received GM604 and four received a placebo) and its short duration (a two-week treatment period followed by a ten-week observation period), the modulations of two of the biomarkers were shown to be statistically significant between the treated and placebo groups. These results are consistent with the previously reported clinical trial results indicated that 7 of the 8 treated definite ALS patients had their disease progression slowed or stopped when compared to the historical ALSFRS-R scores of definite ALS patients over the course of the trial.Genervon is extremely encouraged by these results, particularly given the challenge of detecting even one biomarker signature over such a short trial period, and believes that they support Genervon’s hypothesis that GM604 is a potent “master regulator” drug that modifies ALS by working across multiple genes in multiple pathways through multiple biological processes. Genervon believes that GM604 operates by responding to distress signals from affected genes and regulating those genes bi-directionally to their normal functional ranges, thereby bringing homeostasis to affected biological systems.Genervon further believes that GM604’s multi-target efficacy sets it apart from the single-target strategies that have failed to translate into effective therapies for neurodegenerative and nervous system disorders. As of 2013, 62 companies have a product in development for ALS. More than 160 ALS clinical trials had failed. It is increasingly apparent that single-target drugs cannot cure most neurological diseases. This is not surprising given that the pathogenesis of those diseases is highly interactive and multifactorial, involving multiple biological targets and processes. Genervon believes that because GM604 is an endogenous human peptide that regulates overall neurological development at the embryonic stage, it has the potential to modify neurological diseases where single-target therapies have failed.ALS patients lost the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. There is no cure and no life-prolonging treatments for the disease. GM604 has received orphan drug and fast track designation from FDA to treat ALS.Genervon Biopharmaceuticals LLC, 1055 E. Colorado Blvd. Fifth Floor Pasadena, (323) 721-5500 or visit www.genervon.com/genervon.About GenervonGenervon is a privately held, clinical-stage biopharmaceutical company in California developing breakthrough multi-target biological drugs to address the world’s critical unmet medical needs.SOURCE: Genervon Biopharmaceuticals LLC Community News Pasadena’s ‘626 Day’ Aims to Celebrate City, Boost Local Economy Your email address will not be published. Required fields are marked * Name (required)  Mail (required) (not be published)  Website  Home of the Week: Unique Pasadena Home Located on Madeline Drive, Pasadena Community News Top of the News last_img read more

City halts housing construction

first_imgConstruction on the Legacy Square townhouse development at the corner of Notre Dame Avenue and Sorin Street has come to a halt over zoning issues. Developer Robert Cimala, who was also one of the developers of off-campus student housing development Legacy Village, said his property was set to receive final permits from the South Bend Building Commission. But at the beginning of November, the Building Commission said his plans would have to go to a public hearing before the Area Plan Commission (APC) on Dec. 21 to determine if they are in accordance with PUD zoning provisions.  Cimala said plans for the Legacy Square development began in July 2007. That month, Cimala went to the APC and requested PUD zoning for his property on Notre Dame Ave. and Sorin St. to build 36 units. The APC asked him to reduce the number of units to 32 to be split between two buildings. The APC later asked him to split the two buildings into four. Cimala agreed. Cimala said he had a local architect create the final architecture plan and a civil engineer create the final site plan, which he brought to the Building Commission.  The community meeting could have significant implications for the students who signed leases to live in Legacy Square during the 2011-12 academic year. “The NNRO is interested in this because they don’t believe the plan does conform [to PUD zoning],” Nesbaum said.  “The intent of the law is to encourage owner-occupied, single family residences. This is not an anti-student situation.” Bill Stenz, president of the Northeast Neighborhood Council and resident of the Northeast Neighborhood, said he doesn’t generally mind students living in the neighborhoods close to campus. But when pockets of student housing develop problems tend to arise, he said. Cimala said the object of controversy related to Legacy Square is the local prejudice against Notre Dame students. This process of review could derail the housing project.  After another round of changes, Cimala said Byorni told him he would get final approval for his final building permit when Bulot sent over initialed site plans to the APC. Instead of final approval, Byorni said he was sending the plans back to a public hearing with the City Council in order to see if the Legacy Square plans are still in accordance with the PUD code in their current state.   “Notre Dame students have been given a bad rap by a lot of people,” he said.  “They’re trying to stop me from exercising my legal right to rent each condo to two students until I sell them,” he said.  PUD zoning allows for flexibility in building, and they normally contain private residences and common areas. Cimala said that because of the slow economy and a bad housing market, he has decided to rent some of the condominiums to students until he can sell them.  He said he worked with Chuck Bulot, the building commissioner for the City of South Bend, and APC executive director John Byorni, to make changes to the site plans. He received foundation permits in October. “This year, I was able to obtain construction financing, so I could go on with the project,” he said. Stenz said when pockets of student houses spring up, they can bring down the value of neighboring non-student houses.  “I’m not doing anything that anyone else isn’t doing,” Cimala said. “This is a very nice development, and all I’m doing is what I’m allowed to do under the law.” If the building plans are found to be within guidelines, Cimala will receive his final building permit, and he said he could get the buildings constructed by June 2011, when students could move in on time for the school year.  Cimala said he had to delay the plans until this year because of the general financial downturn.  Attorney Dick Nesbaum said provisions in South Bend zoning codes prohibit more than two unrelated occupants in one home unless the unit is zoned for such occupancy. Legacy Square is zoned to allow no more than two unrelated occupants per condominium. “We showed them our plans,” he said. “We don’t want to go forward with the project with these plans unless they fit the zoning codes.” Nesbaum is the attorney for the Northeast Neighborhood Revitalization Organization (NNRO), a non-profit corporation created for “planning, discussing and coordinating the social, physical and economic revitalization of the Northeast Neighborhood,” according to the Northeast Neighborhood website. The Legacy Square development falls in the Northeast Neighborhood. “Historically, we didn’t have this high of a concentration of students [in the Northeast Neighborhood],” he said. “Students lived throughout the city. Ten to 15 years ago, landlords bought single family house pockets.” “They think it’s a student housing development and that’s all it’s ever going to be,” Cimala said. “I am building a high-end condominium development.” Legacy Square is zoned as a planned unit development (PUD), composed of 32 condominiums in four buildings. The condominiums were developed as high-end housing geared toward single-family, owner-occupied living situations, as opposed to rentals.  He said there is nothing in the South Bend zoning law preventing students from living anywhere in town. If the plans are not approved, however, the end result remains unclear.last_img read more

Manchester United F.C. rated Europe’s most valuable club, beating Real Madrid C.F.

first_imgManchester United F.C. have moved clear of Real Madrid C.F. to be rated as Europe’s most valuable club by professional services firm KPMG.In a KPMG report which looked at the finances of 39 clubs based on their popularity on social media channels, revenues for the 2014-15 and 2015-16 seasons, and success in European competitions, Manchester United F.C. have been valued at 3.004 billion euros, ahead of both Real Madrid C.F. (2.895bn euros) and Barcelona F.C. (2.688bn euros).F.C. Bayern Munich remain in fourth place, while Manchester City F.C.  edge past Arsenal F.C. to take fifth spot, both with enterprise values of just under 1.7 billion euros.Chelsea F.C., Liverpool F.C., Juventus F.C. and Tottenham Hotspurs F.C. are in the next four positions, which mean six of the 10 are from the Premier League.”The aggregate value of Europe’s leading football clubs suggests that the overall value of football, as an industry, has grown,” said KPMG’s global head of sports Andrea Sartori, in a statement.”While this is partially explained by football’s broadcasting boom, the internationalisation of the clubs’ commercial operations, their investment into privately owned and modern facilities, and overall more sustainable management practices are also key reasons for this growth.””In terms of media rights value, the English Premier League sits comfortably at the top of European leagues, although other major leagues have outlined well-defined strategies to compete for the attention of global fans,” he added.last_img read more