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A ‘fleeting moment’ captured: Sea lion dances with bait ball near La Jolla shores - FOX 5 San Diego
2023.06.09 01:46 SeaLionFacts A ‘fleeting moment’ captured: Sea lion dances with bait ball near La Jolla shores - FOX 5 San Diego
2023.06.09 01:39 AutoNewspaperAdmin [Sports] - Phil Mickelson quietly buying up San Diego neighborhood — 21 acres for $70M NY Post
2023.06.09 01:39 imz72 Japan's Reprocell plans to seek approval for its stem cell therapy despite failing to meet the primary efficacy endpoint
(Machine-translated from Japanese):
2023.06.09
On June 7, 2023, Reprocell held a financial results briefing for the fiscal year ending March 2023. The research support business and the PCR testing business performed well, and sales reached a record high since the listing.
The allogeneic adipose-derived mesenchymal stem cells "Stemchymal", which the company had been developing for spinocerebellar degeneration, failed to achieve the primary efficacy endpoint as a result of the domestic phase II clinical trial.
However, the results of the subgroup analysis suggested efficacy, so the plan is to apply for approval based on the results of the phase II trial.
[The rest of the article is behind paywall - imz72]
https://bio.nikkeibp.co.jp/atcl/news/p1/23/06/08/10792/
May 30, 2023
Reprocell reports mixed results for phase II Stemchymal trial in spinocerebellar ataxia
By Tamra Sami
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia (SCA) trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
The phase II trial conducted in Japan was a placebo-controlled, multicenter, randomized, double-blinded, parallel-group study to evaluate the safety and efficacy of the drug. Independently, another phase II trial with a similar design was conducted in Taiwan by the originator, Steminent Biotherapeutics Inc., of San Diego and Taipei. In the Japan study conducted by Reprocell, of Yokohama, Japan, 31 patients received Stemchymal and 28 patients received placebo.
Spinocerebellar degeneration is a rare disease of unknown cause in which degeneration of nerve cells in the cerebellum, brainstem and spinal cord progressively causes ataxia, such as gait and swallowing difficulties, making it difficult for patients to perform daily activities. There are no approved treatments that delay or halt progression of SCAs.
The primary efficacy endpoint was the change in Scale for the Assessment and Rating of Ataxia (SARA) score from baseline to week 52, and in the overall population there was no statistically significant improvement observed in the treatment group compared to the placebo group.
A review of previously published papers showed that a placebo effect was observed in more than 90% of previous clinical trials in spinocerebellar degeneration, and the placebo effect was higher in less severe patients. The placebo effect was reduced in the higher baseline subgroups with baseline SARA scores of 11 or higher, showing a trend closer to the natural history of spinocerebellar degeneration, with SARA scores increasing by roughly one point per year.
The SARA score is based on the investigator's observation of walking, standing, speaking and finger movements to assess symptoms. The worse the symptoms are, the higher the score is. It has eight categories with accumulative scores ranging from 0 (no ataxia) to 40 (most severe ataxia).
Based on the statistical analysis plan and advice from medical experts, a subpopulation analysis was performed based on the predose baseline SARA score, and the disease progression analysis of SARA score showed a statistically significant improvement with a "p" value of 0.042 in baseline 11 or higher. Reprocell concluded that the effect of Stemchymal was evident in the higher baseline subpopulation where the placebo effect was less pronounced.
Even in the subpopulation treatment group with baseline SARA scores of 9 or higher, the change in SARA score until 52 weeks was similar to that of the high-base subpopulation.
A subgroup analysis was also performed in the high-base subgroup for the secondary endpoints of clinical global impression (CGI), patient global impression of improvement (PGI-I) and percentage improvement in SARA scores. The results of these scores indicated that Stemchymal appeared to inhibit disease progression.
The incidence of adverse events with a possibly causal relationship was 77.4% (24/31) in the treatment group and 35.7% (10/28) in the placebo group, but all adverse events in both groups were confirmed to have recovered. No serious adverse events were reported.
Taiwan trial shows consistent results
In the phase II trial in Taiwan, the results of the subgroup analysis of SARA score showed a significant improvement in the treatment group compared to the placebo group in the high-base subgroup, confirming the same trend as in the Japan trial. The Taiwan trial also showed no serious safety issues.
Based on these results, Stemchymal appears to show a certain level of efficacy for spinocerebellar degeneration in a high baseline subpopulation. Although the subpopulation analysis showed efficacy, more detailed studies are needed, the company said.
Administered intravenously, Stemchymal has been designated as a regenerative medicine product for rare diseases in Japan and is eligible for development cost subsidies up to 50%, preferential tax treatment and support measures such as priority review.
“We are pleased that the phase II clinical trial has shown that Stemchymal is expected to be effective in inhibiting disease progression and its safety has been confirmed, and that these clinical data in Japan are consistent with the data independently obtained in Taiwan,” said Reprocell CEO Chikafumi Yokoyama, adding that the company hopes to bring this new treatment to patients in Japan as soon as possible.
Reprocell in-licensed Stemchymal from Steminent Biotherapeutics, which is developing the stem cell therapy for the potential treatment of polyglutamine SCA, knee osteoarthritis and acute liver failure, and investigating it for the potential treatment of Alzheimer's disease and Parkinson's disease, according to Cortellis.
Steminent completed a phase I/II trial with Stemchymal that showed 66% of patients showed improvement in both the SARA score and sensory orientation test scores in the first month following a single infusion of Stemchymal, Steminent reported.
https://www.bioworld.com/articles/697506-reprocell-reports-mixed-results-for-phase-ii-stemchymal-trial-in-spinocerebellar-ataxia
[Reprocell's market cap is $190 million - imz72]:
https://finance.yahoo.com/quote/4978.T
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2023.06.09 01:31 KungfuJesus08 Visiting from MSP and I just have to ask...
What the fuck is wrong with your drivers? Don't get me wrong, I love your city, the downtown area is beautiful, your beer scene is off the charts, the public markets are awesome, probably gained 5 pounds from having to experience all the amazing food. But your drivers are the worst drivers I've ever experienced. It feels like all laws are merely suggestions and nobody gives a shit about following them. I've driven around tons of bigger cities (Seattle, Portland, San Diego, Chicago, Denver, St Louis, Minneapolis obviously) and Milwaukee has by far the craziest, most "don't give a fuck" drivers I've ever seen. I've only been here 2 days and I've had people pass me from the right turn lane at stoplights, blown through lights, drive in the bike lane like it doesn't exist, force themselves into my lane to the point I was convinced we were going to run into each other, go 20 over the speed limit driving through crowded streets, I've had to sit and wait for 2 light cycles because people block the intersections when they get the green light.
Seriously? Who taught everyone here to drive? Does nobody care about getting into accidents? Has it always been like this or is this a recent thing?
Again, love the city, it's amazing, but your drivers scare the shit out of me.
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2023.06.09 01:30 HoodieDisqus Selling an OEM front grille in pristine condition
Only has 500 miles on it. Im sure not many people want to buy it lol but just thought I'd post just in case. Maybe someone has some scratches/chips on theres and wants a new one.
Located in San Diego
$100
Can ship as well would need to confirm how much it costs before hand though
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2023.06.09 01:21 EchoJobs FlockFreight is hiring Senior Software Engineer, Back End (Algorithms Engineering) San Diego, CA Chicago, IL Remote [API SQL MySQL GCP AWS Docker Java JavaScript TypeScript Python Spring Git]
2023.06.09 01:21 EchoJobs FlockFreight is hiring Staff Software Engineer, Back End (Algorithms Engineering) San Diego, CA Chicago, IL Remote [Python Spring AWS Docker MySQL SQL Java JavaScript TypeScript GCP Git API]
2023.06.09 01:21 EchoJobs FlockFreight is hiring Senior Data Engineer (Infrastructure Engineering) San Diego, CA Chicago, IL Remote [SQL Python PostgreSQL Machine Learning Streaming]
2023.06.09 01:19 AutoNewsAdmin [Sports] - Phil Mickelson quietly buying up San Diego neighborhood — 21 acres for $70M
2023.06.09 01:12 EchoJobs FlockFreight is hiring Senior Software Engineer, Developer Experience (Infrastructure Engineering) San Diego, CA Chicago, IL Remote [Go Kubernetes Java Python Node.js]
2023.06.09 01:11 ICantThinkOfAName759 What are these yellow areas on the map? Are they danger zones?
2023.06.09 01:01 EchoJobs FlockFreight is hiring Senior Software Engineer, ML Infrastructure (Infrastructure Engineering) San Diego, CA Remote [Machine Learning GCP Python TensorFlow Kubernetes]
2023.06.09 01:01 EchoJobs FlockFreight is hiring Senior Software Engineer, Back End (Product Engineering) San Diego, CA Seattle, WA [Java Spring AWS Git MySQL SQL C# GCP Docker API]
2023.06.09 01:01 EchoJobs FlockFreight is hiring Senior Software Engineer, Front End (Product Engineering) San Diego, CA Seattle, WA [AWS Git Docker API TypeScript JavaScript React GCP]
2023.06.09 01:01 EchoJobs FlockFreight is hiring Senior Software Engineer, Full Stack (Product Engineering) San Diego, CA Seattle, WA [Git SQL MySQL Spring GCP React AWS Docker API Java JavaScript TypeScript]
2023.06.09 00:52 Leemsmedia Nirvana bootleg collection is getting stirdy
2023.06.09 00:49 BradyJKerr Transition to Sustainability from Operations Management
Hi everyone I'm new on this subreddit and I am trying to transition my career into the field of sustainability. I have worked in retail management and operations management for the same company for the last 10 years, and during that time I have put myself through college to get a degree in sustainability. I have seen lots of job postings for entry-level and mid-level sustainability jobs both in my city of San Diego, and also remote positions throughout the US. I feel like I have been exhausting every option as I have been applying for almost every job that is related to sustainability, but I have barely heard back from any of the companies I have applied to and I'm not sure how I can better market myself in order to break into this industry. My resume focuses on my transferrable skills from my past career, and I also focus on the experiences I have from my internship and my study abroad experience (they were both sustainability / public health related). Has anyone had any similar experiences trying to switch careers and move into sustainability, or switching from an operations management type of role to something else? If so, any help or guidance would be much appreciated. I really just want to work in an industry that I am passionate about and I am willing to do whatever it takes for me to achieve that goal.
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2023.06.09 00:25 Taki-12982 [23][M4F][San Diego/California][USA]
Hello everyone, really don't know how to start this lol, but I just thought of losing my virginity this summer when I'm back home here in Sandiego.
About me: I'm an a introvert most of the time. I say most of the time cause when I go out to festivals and raves I become a social animal. To past time.i usually listen to music, binge watch shit( currently rewatching avatar: the last Airbender), and when I'm that bored I sometime go for a drive even though gas is hella expensive.
Body: not to brag but I lost 20 pounds going from 210-183 and I'm currently fasting to lose more. I'm wasian half Filipino from my mom's side and half white from my dad's side.
I really don't know what to say in this post ngl, but hey dm me and let's see if we can vibe it out.
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2023.06.09 00:17 DanielR1_ Selling Apollo Phantom V2 60V
60V variant is discontinued so this is a rare find!
Will go up to 45mph or more if you’re lighter
Suspension works fine, tires are in good condition, new inner tubes
Less than 400 miles on the scooter
Some cosmetic wear but no functional damage
ZOOM hydraulic brakes
Asking for $1500 but can negotiate
SoCal delivery for free (I will drive it to you) or ship in the US (you pay for shipping)
I Can drive pretty much anywhere from San Diego to Riverside to North LA county
DM if interested!
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2023.06.09 00:15 HannahCantrell Which NWSL match are you most excited about this weekend?
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2023.06.09 00:10 EchoJobs Element Biosciences is hiring Senior Quality Engineer USD 105k-129k San Diego, CA [R]
2023.06.08 23:58 rigov2046 36 [M4F] DMV/NoVa 6’2, Romantic Naval Officer and Professor for Girlfriend- It’s my Birthday!!!
I can only imagine what it would be like to find an incredible woman on here, on my birthday! I have overcome steeper odds, so if you are interested, please read on and inquire within on my journey!
BLUF (Bottom Line Up Front): Stats and Interests Below the Cut-Line. Rationale and Compatibility Analysis Directly Below.
::::::::
I am seeking monogamy and commitment from one lady and I am willing to show the same. Currently located in Northern Virginia, but will undoubtedly re-locate due to my career within the next 18 months or so.
I think that the only reasons we might not be compatible are preferences for looks, our careers (especially me in the Navy), sexual compatibility, and how we spend our free time. As for other reasons- I pride myself in communication, problem solving, patience, chivalry, authenticity, and being altruistic.
————————
Statistics: 6’2, Soon to be 36 YO, 196 lbs, 34 waist, Pulse 52, BP 118/72, Shoe- 12, xxx-7.25, Credit Score 807. Foster Homes Lived In-28, Schools Attended- 23. 43 countries visited, Deployments (USN)- 5, Kids- 0. Black Hair, Hazel Eyes, Lean-Athletic Muscular build. Sweet smile, great calves, aging grey temples, youthful/positive face. The usually response I get is either “fuck yes” or “fuck no” - I realize I am not everyone’s type. 5k PR: 1557- college. Mile-4:17- high school (RI all-state). Undergrad: USNA. Master’s: GWU, USNWC
Red Flags 2 Marriages, 1 other Engagement. Broken hearts- many. Times broken-hearted- 2. Currently separated (Divorce Final-October, no intentions to reconcile). Introverted and Calculated decision maker due to upbringing. Analytical for good and bad reasons. Harry Potter House Ravenclaw Hat-Stall to Slytherin. Left-Handed, 800M SAT Score. Have won over 600k lifetime gambling (A hobby now, used to be a matter of life/death when I was youngehomeless as a teen).
Personality Assessment: Altruistic and Thoughtful people-pleaser. Detail-oriented and sexually charged gentleman. More cooperative and curious than critical. Constantly self-assessing and self-correcting, reflective and strives for improvement. Aims to use own experience to better others in close proximity and to scale. INTJ, love languages physical touch and quality time. Future POTUS, RI GOV, or Government SES, Navy Ship Captain. Vulnerability, Passion, and Compassion are Hallmarks (See Brene Brown/Esther Perel TED Talks).
Interests: Sports fanatic- specifically Boston teams. Board/Card games. Intellectual/Philosophical conversations. Human Behavior, Running, Walking, Pokémon Go, improving my teams around me, including family. Road trips, traveling- especially San Diego, Miami, Vegas, NYC, the beach, kissing, giving massages, finding a partner who wants to deeply connect romantically and physically and discuss and act out our fantasies. Improving our EQ and erotic intelligence together.
Someone will really like this and I hope if you are interested, we could write our success story here. I am an eternal optimist and I realize that you can’t small talk on apps the way I would really like to get to the heart of serious issues. If you are genuinely ambitious yet humble from our beginnings- maybe one of us is the First Spouse to the other, or, the half of a great partnership and earn the title of best parent, or co-chefs in our house together. Coach of the kids’s sports team is cool, too.
I have almost all the pieces I have to make life great and for me it is- just hoping to find that force multiplier where we can enhance our lives and take each other to a place of leadership and bliss that not even we can imagine right now!
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