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SOFO - Q4 guidance given back in August 2005
*Revenue
Total revenue of approximately $3 million in Q4.
*Gross Margin
Q4-2005 gross margins in upper 60%.
*Operating Expenses
Consistent with Q3 despite anticipated growth in revenue.
*Net loss per share in Q4 of $0.01, $0.00 in Q1 of 2006.
You can view this part of their presentation on the link below. Management refers to this in guidance/conclusion. Move curser to 21:10-24:00.
http://msite.sonicfoundry.com/mediasite/viewer/NoPopupRedirector.aspx?peid=3e7ee58a-c2c6-4696-9f22-0...
This Thursday, December 1, 2005 is when SOFO will have their most recent Conference Call confirming what the investment community was told back in August. Should be interesting!
Sonic Foundry Launches Mediasite in Japan
http://biz.yahoo.com/prnews/050517/latu020.html?.v=11
Tuesday May 17, 6:11 am ET
Company's Family of Popular Rich Media Recorders Receives Enthusiastic Response in One of the Industry's Fastest Growing Technology Markets
MADISON, Wis., May 17 /PRNewswire-FirstCall/ -- Sonic Foundry® Inc. (Nasdaq: SOFO - News), a leader in automated rich media solutions, today announced its launch into Pac-Asia by unveiling the first internationalized version of its award-winning Mediasite(TM) line of rich media systems. Developed specifically for the Japanese market, the launch follows a successful eight-month market evaluation in which Sonic Foundry and its master distributor in Japan, Mediasite KK, received enthusiastic interest from Japanese universities, corporations and other organizations looking to leverage the power of rich media communications. To date, more than 50 Mediasite units have been sold in Japan and both companies expect to quickly expand the channel and customer base as the business plan is put into action.
Sonic Foundry and Mediasite KK's jointly developed offerings will be marketed as "Mediasite Live" to clearly distinguish them from the North American versions of the product family. The Mediasite Live line of products mirrors the same functionality as its original North American counterpart, but, is customized with Japanese language, preferences and accessories.
As Mediasite's popularity has increased, Sonic Foundry began extending its reach beyond North America to other parts of the globe. Its focus on Japan is due to the fast-paced growth of the overall Asia Pacific demand for rich content over broadband networks, the rapid adoption of distance learning within its higher education community and its natural affinity to visual and graphical content. The move is part of Sonic Foundry's overall growth strategy to continue building momentum not only through deepening its presence within its existing customer base but expanding to new markets as well.
"Japan represents a substantial and exciting market for rich media solutions. Together with our well-established partner, we can seize an opportunity that promises significant innovation and long-term growth," said James Dias, senior vice president, marketing, business acceleration for Sonic Foundry. "We are executing this same market development approach for gaining a stronghold in other worldwide markets."
In the three years since it was first introduced, Mediasite has set the standard as the premier automated rich media system in the industry for the capture, management and delivery of presentations and meetings for live or on-demand viewing. With Mediasite, every aspect of a presentation is recorded transparently in real-time, is ready for distribution instantly and can be accessed immediately over a browser. To date, more than 269 organizations in education, business, health and engineering in North America use Mediasite for a variety of applications, including Web-based distance education, corporate communications and online training.
In just six months, Mediasite KK has signed several significant customers in Japan in a variety of markets using Mediasite in a variety of applications. They include:
* Meisei University -- dedicated to training practical and international
students, the higher ed institution is broadcasting live lectures from
its Tokyo to Okinawa campus.
* Senshu University -- one of Japan's leading universities for social
science, Mediasite is being used for capturing video conferencing
between rooms across their several campuses.
* Deloitte Touche Tohmatsu -- one of the four biggest accounting firms
in Japan, it is recording and publishing their payment management
seminars.
* Kao -- one of the leading consumer chemistry and cosmetic companies in
the Far East, Kao is using Mediasite for training and internal
communications.
* SRA -- one of the leading system integration companies in Japan, it is
using Mediasite for internal training and external seminars.
"It is with great excitement and honor that we embark on this partnership with Sonic Foundry," said Yoichi Ozasa, director, Mediasite KK. "After many months of due diligence, research and market feedback, we are confident that this is the right technology to meet a broad range of applications for the rich media market here in Pacific Asia. We look forward to making Mediasite Live as successful here as it already has become in North America."
Mediasite Live is available for immediate delivery in Japan.
About Sonic Foundry®, Inc.
Founded in 1991, Sonic Foundry (Nasdaq: SOFO - News) is a provider of automated rich media communications technology for the enterprise. The company's high-performance rich media presentation systems are trusted by Fortune 500 companies, education institutions and government agencies for a variety of critical communication needs. Sonic Foundry is based in Madison, Wis. For more information about Sonic Foundry, visit the company's Web site at www.sonicfoundry.com
SOFO - 2005 Shareholder meeting
Attached is the link to the 2005 Shareholder meeting from earlier this year which I could not attend due to other obligations. Their annual meeting was "captured" using their Mediasite™ product.
http://msite.sonicfoundry.com/mediasite/viewer/?peid=a13b6184-ce03-4313-9693-5dd9af3100af
Cheers and best regards
Welcome to the message board for Sonic Foundry.
I would like to extend an invitation to individuals who are currently Sonic Foundry investors or those who are considering taking up a position in the company. I will certainly do my best to keep the board updated with relevant information.
Best Regards
[OT]-SOFO
Dew,
Have you come to any conclusions or have you decided to wait for the upcoming CC and confirmation of the sales trend of MediaSite which should be announced in the next two weeks.
b regards
OSIP
Is this a good opportunity to buy? Just looking for opinions.
TIA
[OT] SOFO
http://biz.yahoo.com/prnews/051018/latu051.html?.v=29
Sonic Foundry Surpasses 150 Higher Education Customers, Leads Rich Media Charge at Educause 2005
Tuesday October 18, 7:05 am ET
Company Showcases New Mediasite Solutions at Educause 2005 Reflecting Its Growing Momentum at Colleges and Universities Worldwide
ORLANDO, Fla., EDUCAUSE 2005, Booth #735, Oct. 18 /PRNewswire-FirstCall/ -- Sonic Foundry® Inc. (Nasdaq: SOFO - News), the worldwide leader in automated rich media solutions, today announced that more than 150 higher education institutions worldwide are utilizing its award-winning rich media communications system, Mediasite(TM). As the pioneer and inventor of the original Rich Media Recorder and now the provider of the broadest range of rich media solutions, Sonic Foundry's Mediasite has quickly captured the attention of leading universities and colleges for its simplicity, cost- effectiveness, powerful Web communications capability and strong content management tools.
At Educause, Mediasite will be featured not only in Sonic Foundry's booth (#735), but, elsewhere on the show floor, including Dell's highly sought after "Classroom of the Future" (booth #1230). In addition, Sean Brown, Vice President - Higher Education at Sonic Foundry, will speak on "Strategies for Building a Rich Media Learning Environment." Brown will offer replicable steps for using rich media to meet student demand for learning convenience and flexibility during his presentation slated for Friday from 9:30 to 10:20 a.m. in Meeting Room W204A.
Mediasite eliminates the adoption barriers to online teaching and learning by transparently recording instructors in the natural classroom environment without interfering with their teaching style or content. For faculty, it means reduced time in coursework preparation and the ability to teach the way they want to teach. For students learning remotely, it provides an exceptional online representation of the classroom experience, complete with audio, video and synchronized instructional materials, as well as interactive polling and Q&A. Rich media course content is available live or on-demand with the benefits of anytime/anywhere convenience. It lifts restrictions to the typical scheduled in-person classroom or lecture experience and offers students a convenient, on-demand learning environment.
"Higher education is leading the adoption of rich media throughout the world," noted Rimas Buinevicius, chairman and CEO of Sonic Foundry. "Institutions across the globe are realizing the value of distance learning, continuing education and professional development. Through Mediasite, we're empowering students to learn on their terms, at their own pace and at their convenience. It is rapidly changing the way schools teach, offer their curriculum and how students attain their degrees. It's indicative of the coming wave of rich media as the new way to communicate."
In its 2004 report, "Online Distance Education Market Update: A Nascent Market Begins to Mature," research firm Eduventures predicts that the number of fully online distance education programs will grow by at least 20 percent over the next three years and tuition revenues from these programs currently represents more than $5 billion annually. Further, although the early years of online learning were dominated by for-profit entities, Eduventures believes traditional institutions will overtake the lead based on brand strength and awareness.
"We were one of Sonic Foundry's first customers," explained Nick Laudato, associate director of instructional technology for the University of Pittsburgh's Center for Instructional Development and Distance Education. "Since our initial purchase of Mediasite, we have expanded our online capabilities in terms of quality, variety, flexibility and reach. Mediasite has helped us enhance our course offerings and improve their efficiency and effectiveness. It also has allowed us to reach students who couldn't otherwise attend our institution," he said. The University of Pittsburgh's Graduate School of Public and International Affairs is an excellent case in point. Last May, it graduated its first class of students who received their graduate degrees via distance learning enhanced with Mediasite -- six time zones away in Macedonia.
Key higher education institutions that are using Mediasite include: Johns Hopkins University, UCLA, Drexel University, Northwestern University, New York University, University of Pittsburgh, Villanova University, Purdue University - Fort Wayne and Cornell University.
Sonic Foundry is changing the way organizations communicate via the Web and how people around the globe receive vital information needed for work, professional advancement, safety and education. The company's Mediasite solution empowers customers to quickly and cost-effectively create and deliver rich media content that includes fully integrated audio, video and presentation graphics with the ease of a few mouse clicks. Organizations and individuals throughout the world are able to mediasite their presentations, lectures, meetings and events to create a rich end-user experience that far surpasses conventional Web conferencing or text-based blogs.
About Sonic Foundry®, Inc.
Founded in 1991, Sonic Foundry (Nasdaq: SOFO - News) is a provider of automated rich media communications technology for the enterprise. The company's high-performance rich media presentation systems are trusted by Fortune 500 companies, education institutions and government agencies for a variety of critical communication needs. Sonic Foundry is based in Madison, Wis. For more information about Sonic Foundry, visit the company's Website at www.sonicfoundry.com
[OT] Re:SOFO - Dew
"Here’s a question I have about Mediasite itself (not about the company): How do you rewind and fast-forward manually? The only way to move the tape seems to be by selecting a specific slide, which is an inefficient way to replay a short passage that you just heard."
Good question. Simply move the button which sits on horizontal line just above the "play", "pause" and "stop" buttons just below the viewer screen of the presenter. Move the "round button" with your mouse to the desired location in the presentation.
Madison WI is only 70 minutes form my house and I venture that way at least once every few months. No problem viewing the parking lot. ;)
[OT] Re:SOFO
Two questions:
1. Do you know anything about the competitors mentioned in the 10K excerpt I cited?
I do not know much about the current competitors. Some of SOFO's older competition has gone out of business like Media 100 Inc. (MDEA). This is a major weakness on my part and I apologize.
2. Do you know anyone at the company? (If not, how did you become interested in them?)
Unfortunately I do not know anyone from the company. I follow some of the smaller Wisconsin based companies and took more of an interest in Sonic when they decided to sell their Audio Software products to Sony a few years back. Sonic management took the $19 Million from Sony and quickly and quietly established a business model based on Mediasite™ technology.
Additionally, I also consider it a positive sign when the senior management group has a vested interest in the company. They collectively own 17% with another 22% held by Institutions. In short, I have followed the Sonic Foundry story approximately for the last 5 years.
Best Regards
OT] SOFO: Dew
From SOFO 10K
"Our ability to become a profitable and sustainable business is highly dependent on the growth of the Internet and the use of rich media for general communications."
Growth in the Internet should continue at a substantial pace given the introduction of computers at the K-12 grade. Also, with today’s hectic schedule and the cost of higher education, there is considerable growth opportunity in the educational sector which more are becoming available from home residence. Also, as "big business" continues to look for ways to reduce expenses, products like Mediasite™ tool should be sold into this area as a means to improve communication within the big company environment while achieving cost savings by reducing travel expenses. Sonics' recent expansion into Japanese market signifies an international market opportunity for future growth. Also, I believe their profit margin for Mediasite™ has continued to improve from quarter to quarter as well.
FWIW
[OT] Re: SOFO
Sorry for the delay, long weekend. My understanding is that Sonic Foundry today is basically a still a new company starting with limited resources. This includes finding and hiring the right sales personnel which have "necessary" contacts in the opportunistic markets (Government, Higher education, big businesses). It appears that Sonic in the last 1-2 years has started building market share consistently from quarter-quarter and recently added to there sales team. It is my opinion today that Sonic has been conservative in their approach because they do not want to attract too much attention from there competitors.
I like their approach working with higher education because these folks will eventually move out into the job market into many different sectors and “may” eventually be directly responsible for promoting the product/services provided leading to further SOFO growth.
JMHO
Rich
GTCB
Results for the ATryn approval odds and effect on share price Survey.....I would like to know what criteria was used by the three individuals who gave EMEA appproval odds of <50% by October. My sincere complements to them for making the correct call.
As a long time Chicago Cubs fan would say, there is always next year. ;)
Re:GTCB
Is it still possible to have a formal opinion from the EMEA in October apropos the Q&A submitted back on July 8?
Best Regards
Rich
GSK invests further in flu vaccine capacity
September 5, 2005 by Phil Taylor
http://www.in-pharmatechnologist.com/news/ng.asp?n=62283&m=1IPE905&c=bdsisgfqpmjxwyj
GlaxoSmithKline has acquired a manufacturing facility in the USA from Wyeth, and will invest at least $100 million (€80m) to develop and produce flu vaccines at the site using new tissue culture technology.
GSK said the facility "will be used to help develop the next generation of vaccines," particularly in the influenza field. This is the latest in a series of investments in the vaccines filed at GSK, which last month said it was double production of flu vaccines at its Dresden, Germany manufacturing facility.
GSK has paid an undisclosed sum for the facility, which is located in Marietta, Pennsylvania and has been closed since the end of last year. The 90-acre site will now be used for the secondary production of several new vaccines for distribution in the US market, following approval by the US Food and Drug Administration and the new owners added that the facility has freeze-drying capabilities that will be used to enhance the shelf life and stability of a number of its products.
The move will create around 270 jobs within five years and retain 6,900 existing employees located throughout the world.
GSK chief executive Jean-Pierre Garnier said the company expects to develop new flu vaccine technology at the Marietta facility, which "we hope will enhance our future ability to rapidly produce flu vaccines for the nation in response to a pandemic."
GSK further boosted its presence in the vaccines field recently with the acquisition of its long-term US vaccines partner Corixa for $300 million. The company has also just won FDA approval to market its flu vaccine Fluarix, in time for the 2005-2006 flu season.
One of the reasons for rising use of flu vaccines is fear of the next flu ‘pandemic' – outbreaks of new flu strains, often passing to man from animals – that historically have hit every couple of decades, killing millions around the world.
The worst outbreak of the 20th century came in 1918-1919, where the strain known as Spanish flu caused 40-50 million deaths worldwide. Less serious outbreaks occurred in 1957-8 (Asian flu) and 1968-9 (Hong Kong flu), but since then there have been none, leading some to speculate that the next outbreak is just around the corner.
RE NXXI
Swampboots,
Careful with this one, not to be messed with IMHO. This company is in my area of biz and would advise walking on the other side of the street.
RE: GTCB
St armands...I still am holding all my shares and have decided to wait out the "EMEA" ruling. I like others was surprised by the recent financing, but after discussing the situation with my spouse, we are going wait. I sincerely hope the recent financing does not reflect GTCB senior management’s opinion of ATryn chances of approval in October. After going through two sets of Q&A with the EMEA, I believe they (EMEA) will either give a positive ruling or flag the project. FWIW IMHO.
Best Regards
Rich
GTCB-Short interest
Short interest in GTCB increased over 1300% in the last month.
As of August 15 short interest was 888,614 up from 59,635 on July 15. Is it possible/likely that the PP investors shorted this stock knowing that after the announcement of the placement, the PPS would fall dramatically? How can this be legal? TIA
Scientists isolating 'useful' genes in milk
This has nothing to do with GTCB, but an interesting article anyway. IMHO
http://www.foodnavigator-usa.com/news/ng.asp?n=62037&m=1FNU824&c=fxttxcoigttugiw
By Chris Mercer
8/23/2005 - International experts in nutrition and genomics will meet in California to discuss the progress of research into links between the genetic make-up of milk and human health. (What about Goat milk dammit!!)
The two-day event, to take place on 10 and 11 November, will be the second ‘Symposium on Milk Genomics and Human Health' to have been held by the California Dairy Research Foundation (CDRF).
A number of high-profile researchers are expected to attend, including Martin Grigorov of the Nestlé Research Centre in Switzerland, highlighting the dairy industry's growing interest in the potential benefits of genome research.
A University of California project has spent the last year building up a databank containing the different genes making up milk. Researchers from the US, Canada, Australia, New Zealand, Ireland, the Netherlands and Switzerland have all taken part.
From this, the team aims to discover more about how certain genes contribute to the make-up of milk and what their role is; for example, which molecules are linked to certain health benefits and how.
“The study of genomics allows us to go beyond simply understanding that milk is beneficial and challenges us to discover precisely how and why,” said Prof. J. Bruce German of the University of California.
The research offers obvious advantages for firms looking to enhance products or make specific health claims.
And, from a nutritional point of view, German added that the project should improve a producer's ability to position products for specific consumers; something highlighted as a major area of interest by market research group Euromonitor, in a recent global dairy products report.
The researchers will present an up-date on their work at the November symposium. Last year's event led to the formation of the global Milk Genomics Consortium. For more information on this, contact the CDRF
The process of systematically collecting biological information on computers for analysis, known as bioinformatics, is also the focus of a new, year-long project in the UK.
Scientists at Britain's Campden and Chorleywood Food Research Centre want to show how the technique could be relevant to food and drink firms in a variety of situations.
John Dooley, a scientist on the project, believes bioinformatics are most likely to help firms predict the allergenicity and functionality of products by examining their ingredients' protein structures.
He said that by identifying the right proteins it may even be possible to replace or remove certain ones to reduce the likelihood of a product causing an allergic reaction in the consumer.
Dooley added that although bioinformatics technology was progressing quickly, it was still in its infancy in relation to these processes. “At this stage the information is not there, but the project will help the industry to know that they could have it in the future.”
The technology remains fairly imprecise because it is hard to predict what different proteins will do, even if they appear similar to others.
Proteins and genomes often have multiple tasks too, and so it is hard to know what side-effects may be caused by altering, removing or replacing them.
Re MTBE FWIW
One additional comment. Back in the mid 1990's when MTBE was used here in Wisconsin before it was ban, we had two small GM sport utility vehicles and notice between a 10-15% reduction in our gas mileage. Further, the exhaust from the vehicles was awful.
Over 12 hrs
It's been over 12 hrs without a post from Dew. :)
Maybe he drove to GTCB headquarters and expressed his opinion about the dilution. Perhaps someone run to his house and make sure everything is cool!
RE: GTCB
My vote is for #5.
Just a company with superb prospects for improving revenues and an excellent future.
Have a great weekend!
GTCB
Thanks Dew. Already took survey. Have a good weekend.
Rich
GTCB
Survey update? TIA
GTCB
Dew,
Here is my proposed survey. Please feel free to amend at your discretion.
Rich
What do you currently believe GTCB’s odds are of the EMEA ruling in favor (positive) for approval for ATryn before the end of October?
A <50%
B 50-59%
C 60-69%
D 70-79%
E > 80%
Assuming GTCB receives a positive ruling by the EMEA, what market cap would you assign for GTCB, excluding all other potential positive announcements regarding other GTCB projects/partnerships?
A <150 Million
B 150-200 Million
C 200-250 Million
D 300-350 Million
E 350-400 Million
F > 400 Million
GTCB
Would anyone care to share their opinion regarding the odds of the EMEA ruling in favor (positive) for approval for ATryn? My SWAG at this point is 80% in favor of a positive opinion from the EMEA. Perhaps another survey for "fun" would be of interest.
Best Regards
How many of you currently are GTCB shareholders
A Yes
B No
C Not yet, but considering
When will GTCB ink an ATryn partnership for EU?
A In 3rd Qtr of 2005
B In 4th Qtr of 2005
C In 2006
D In 2007 or later
E Never: they will go it alone
When will GTCB ink an ATryn partnership for US?
A In 3rd Qtr of 2005
B In 4th Qtr of 2005
C In 2006
D In 2007 or later
E Never: they will go it alone
GTCB
Dew, I would be very interested in seeing a survey of the readers here who are GTCB shareholders and what their expectaions are regarding a BP partnership for ATryn. Thanks as always for your consideration.
b regards
To test or not to test?
I have disclosed this to the group a while back, but thought I would share again what happen to me a while back. Three years ago I developed a DVT (deep vein thrombosis) behind my left knee at the age of 37, specifically the popliteal vein.
I gave myself 7 shots of Lovenox (1 week) until the oral dosage of coumadin reached therapeutic levels. The standard regimen was coumadin for 6 months. After 6 months of treatment, my doctor declared me healthy without further testing to determine the cause-effect of my condition that lead to the DVT. I seriously questioned and challenged his decision.
After a few months of contemplation, I found a specialist and reviewed my case with him. We agreed together that further testing should be conducted which would help elucidate my specific condition. The resulting test identified that I had Factor V Leiden. This is not a disease; instead it is the presence of a particular gene that is passed on from one or both of my parents, in my case only one of my parents. Individuals that carry the Factor V Leiden gene have a five times greater risk of developing a blood clot (thrombosis) than the rest of the population. It is important to state that many people with the gene will never suffer from blood clots.
Ok, you might ask what is next. According to the medical community that I have spoken to, it is unclear how individuals with my condition should be treated, if at all.
Here is the scary thing. Approximately 5% of the US population has Factor V Leiden. That is 14.8 Million people in the US alone have this condition. Most have no idea of there potentially dangerous condition. I have often wondered if David Bloom of NBC had Factor V Leiden. He suffered a PE after complaining of leg discomfort for several days.
I am glad I pushed the medical community to get tested. I travel to China and Europe frequently and I now address my physical condition accordingly on these very long flights.
For two years now I have taken a dietary supplement that “may” help prevent DVTs. Most dietary supplements have similar MOA like aspirin in that they may help prevent arterial blood clots, but not venous blood clots. The doctor friend I have spoken to strongly believes a supplement called Nattokinase NSK-SD may prevent DVT's. Unfortunately, not all Nattokinase on the market is safe (IMHO). Natto (fermented soy beans) contains naturally high levels of Vitamin K. Vitamin K help improve blood clotting mechanism. With the help of my physician friend, I have identified a reliable high quality Nattokinase (manufactured by Amano Enzyme). No, this is not a commercial. I am just trying to share as much information w/o going into lecture mode.
So what is my point? I believe in taking personal responsibility for ones health. When I doubt, get tested and talk openly with your doctor friends.
mblimon
Welcome and thank you very much for sharing your insight. Good luck with your Pharming & GTCB investments. Cheers!
Rich
RE: GTCB
Dew & Urche,
Gentlemen....Thank you very much for sharing your insight, time and efforts.
regards
YMI
Randy,
According to a poster on the DNDN Yahoo MB, they recently stated that "The Norelin vaccine targets a factor that increases testosterone. Therefore, it is designed to inhibit testosterone production in ADPC. Provenge inhibits tumor growth so both vaccines are complementary rather that competing." I need to research this much more myself.
regards
YM BioSciences achieves primary objective with Norelin(TM) study
Wednesday May 25, 7:00 am ET
MISSISSAUGA, ON, May 25 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), the cancer product development company, announced today that Norelin(TM), its anti-cancer vaccine targeting the gonadotropin releasing hormone (GnRH), has successfully completed a proof of concept study in men with hormone dependent prostate cancer (HDPC). The majority of patients with HDPC treated with Norelin(TM) developed antibodies to GnRH, demonstrating the development of an immunological response, which was the primary objective of the trial.
The trial enrolled patients in two stages. In the first stage (results reported in June of 2003), 12 patients were enrolled and treated with the Company's proprietary formulation of Norelin(TM) and were followed for 90 days. In the second stage, four patients were enrolled starting in mid-2004 and followed for 180 days before determining whether or not they responded. YM originally planned to enroll a total of 12 patients in the second stage, but voluntarily terminated enrollment of the trial when delays in trial implementation resulted in clinical supplies of the drug exceeding stability time-limits. The drug substance demonstrated excellent stability for four years, more than sufficient to consider it commercializable.
Patients from the first stage whose testosterone dropped significantly at 90 days were advanced onto a long-term booster program. Seven of the 12 enrolled patients developed anti-GnRH antibodies and two went on to achieve castrate levels of testosterone by day 120. Those two patients received booster doses for approximately two years and are in long-term follow-up. They remain at castrate levels with normalized PSA and have not demonstrated any sign of disease progression at more than 2.5 years.
Three patients from the first stage and three patients from the second stage received at least five doses of the vaccine and these patients were followed for 120 days. All responded to the vaccine, developing antibodies and achieving testosterone suppression. Three of these patients achieved complete castration of testosterone and normalized PSA.
David Allan, Chairman & CEO of YM BioSciences commented "The first cohort demonstrated the proof of concept but also suggested that we needed to follow patients longer than the initial target of 90 days to observe a good response. While the second cohort only enrolled a total of four patients who were to be followed for 180 days, the data are sufficiently compelling to take this drug forward into larger trials."
Adverse events reported included injection site pain in 8/16 (50%) patients, hot flashes 3/16 (19%), nausea 2/16 (13%), decreased libido 1/16 (6%) and headache 1/16 (6%). There was no testosterone flare and no bone pain or worsening of symptoms reported.
Sean Thompson, Director of Corporate Development for YM BioSciences and project leader for Norelin(TM) added, "We are pleased with the results of this proof of concept study and now understand the appropriate dosing regimen and the follow-up schedule for this product. We additionally have early evidence that this approach may be better tolerated than currently available therapies. We now need to manufacture more material, study a larger group of patients and then go to the FDA with a registration plan."
I just got back from Shanghai this weekend. I noticed this morning that I'm coughing up feathers. Could this be the start of the dreaded "bird flu" ? ;)
YMI - To good to be true?
http://biz.yahoo.com/prnews/050519/to029.html?.v=5
YM BioSciences survival analysis data published at ASCO
Thursday May 19, 7:30 am ET
MISSISSAUGA, ON, May 19 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), the cancer product development company, today announced that updated results for a completed phase III metastatic breast cancer trial using the Company's lead drug, tesmilifene, were released in conjunction with an abstract published in the Proceedings of the 2005 American Society of Clinical Oncology's (ASCO) annual meeting. The abstract (No. 756) describes an analysis of overall survival in a subgroup of patients enrolled in the "MA.19" trial.
A total of 305 patients were enrolled in the MA.19 trial. Of the 191 patients in whom cancer metastasized or recurred within 36 months from original diagnosis to trial entry, patients in the arm combining doxorubicin with tesmilifene had a median survival of 29.7 months compared to 12.2 months for patients on doxorubicin alone, a 143% improvement in overall survival (p(equal sign)0.0016). The patient population of 305 was divided into tertiles of patients who had a disease-free interval (DFI) of greater than 36 months, 6 to 36 months and less than 6 months. The DFI group greater than 36 months demonstrated no benefit from the additional tesmilifene while the combined groups of less than 36 months DFI demonstrated the significant 143% difference in this unplanned, post-hoc analysis.
A review of possible prognostic or post treatment factors demonstrated that none could have contributed to the significant increase in overall survival compared to the trial as a whole. The data from the full complement in MA.19 (J. Clinical Oncology, 22:269-276, January 15, 2004) reported that the median survival in the arm of doxorubicin plus tesmilifene was 23.6 months compared to 15.6 months for patients on doxorubicin alone, a 51% improvement in overall survival (p less than 0.03).
The published analysis that tesmilifene appeared most effective in patients with early metastatic disease or ER and PR negative tumours complements pre-clinical observations which demonstrated that tesmilifene's potentiation of chemotherapies is primarily evident in mdr+ cells. The important differential in overall survival observed in women treated with tesmilifene plus doxorubicin compared to doxorubicin alone in the subpopulation of patients with rapidly progressing disease is thought to be attributable to the effect of tesmilifene on mdr+ cells.
In MA.19, response rates and median progression-free survival were not different. The subset analysis appears to suggest that the differential effect of tesmilifene on the minority population on mdr+ cells causes the (late) survival benefit in the absence of an (early) response difference or a difference in progression-free survival. This hypothesis is being further explored in a currently ongoing trial of epirubicin plus cyclophosphamide with or without tesmilifene in patients with early-recurring advance breast cancer.
This latter trial, known as "DEC", is being undertaken by YM and is a pivotal Phase III trial enrolling 700 women in more than 100 hospitals and 20 countries worldwide. As at today's date 420 women have been enrolled and recruitment is anticipated to be complete in Q3 2005. Under an agreement with the FDA, the trial is subject to a sequential analysis under which the trial could be completed if an agreed differential in survival is demonstrated after 192 events. If the survival in the control arm mirrors the results from the similar population in MA.19, YM anticipates the trial could be completed in mid-2006 and, if the outcomes are positive, tesmilifene could be available to patients in mid-2007.
ASCO Publication Abstract No. 756
Title: Subgroup analysis of a phase III trial of doxorubicin vs. doxorubicin plus tesmilifene in advanced breast cancer (ABC): Tesmilifene survival benefit focused on patients with more aggressive disease.
Short Title: Subset analysis randomized breast
Category: Breast Cancer
SubCategory: Metastatic Breast Cancer
Author(s): M.D. Vincent, P. Keane, H. Chen, K. Pritchard; London Regional Cancer Program, London, ON, Canada; YM BioSciences Inc., Toronto, ON, Canada; McDougall Scientific Ltd., Toronto, ON, Canada; Sunnybrook Regional Cancer Centre, Toronto, ON, Canada
About YM BioSciences
YM BioSciences Inc. is a cancer product development company. Its lead drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer. Published results from tesmilifene's first Phase III trial in the same indication demonstrated a substantial increase in survival for women treated with the combination of tesmilifene and chemotherapy compared to chemotherapy alone, demonstrating that tesmilifene significantly enhanced the therapeutic effect of chemotherapy. In addition to tesmilifene, the Company is developing TheraCIM hR3, an EGFr humanized monoclonal antibody on which Phase II clinical data have recently been released in pediatric glioma and nasopharyngeal cancer, and for which Phase III IND applications have been filed, and a GnRH anti-cancer vaccine that is in earlier stage clinical trials. YM BioSciences recently acquired DELEX Therapeutics Inc., a private clinical stage biotechnology company developing AeroLEF(TM), a unique inhalation-delivered formulation of the established drug, fentanyl, to treat acute pain including cancer pain. This product has completed a Phase IIa trial with positive results and YM proposes to advance AeroLEF(TM) through a Phase IIb pain trial in 2005.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
OT-Sonic Foundry Launches Mediasite in Japan
http://biz.yahoo.com/prnews/050517/latu020.html?.v=11
Tuesday May 17, 6:11 am ET
Company's Family of Popular Rich Media Recorders Receives Enthusiastic Response in One of the Industry's Fastest Growing Technology Markets
MADISON, Wis., May 17 /PRNewswire-FirstCall/ -- Sonic Foundry® Inc. (Nasdaq: SOFO - News), a leader in automated rich media solutions, today announced its launch into Pac-Asia by unveiling the first internationalized version of its award-winning Mediasite(TM) line of rich media systems. Developed specifically for the Japanese market, the launch follows a successful eight-month market evaluation in which Sonic Foundry and its master distributor in Japan, Mediasite KK, received enthusiastic interest from Japanese universities, corporations and other organizations looking to leverage the power of rich media communications. To date, more than 50 Mediasite units have been sold in Japan and both companies expect to quickly expand the channel and customer base as the business plan is put into action.
Sonic Foundry and Mediasite KK's jointly developed offerings will be marketed as "Mediasite Live" to clearly distinguish them from the North American versions of the product family. The Mediasite Live line of products mirrors the same functionality as its original North American counterpart, but, is customized with Japanese language, preferences and accessories.
As Mediasite's popularity has increased, Sonic Foundry began extending its reach beyond North America to other parts of the globe. Its focus on Japan is due to the fast-paced growth of the overall Asia Pacific demand for rich content over broadband networks, the rapid adoption of distance learning within its higher education community and its natural affinity to visual and graphical content. The move is part of Sonic Foundry's overall growth strategy to continue building momentum not only through deepening its presence within its existing customer base but expanding to new markets as well.
"Japan represents a substantial and exciting market for rich media solutions. Together with our well-established partner, we can seize an opportunity that promises significant innovation and long-term growth," said James Dias, senior vice president, marketing, business acceleration for Sonic Foundry. "We are executing this same market development approach for gaining a stronghold in other worldwide markets."
In the three years since it was first introduced, Mediasite has set the standard as the premier automated rich media system in the industry for the capture, management and delivery of presentations and meetings for live or on-demand viewing. With Mediasite, every aspect of a presentation is recorded transparently in real-time, is ready for distribution instantly and can be accessed immediately over a browser. To date, more than 269 organizations in education, business, health and engineering in North America use Mediasite for a variety of applications, including Web-based distance education, corporate communications and online training.
In just six months, Mediasite KK has signed several significant customers in Japan in a variety of markets using Mediasite in a variety of applications. They include:
* Meisei University -- dedicated to training practical and international
students, the higher ed institution is broadcasting live lectures from
its Tokyo to Okinawa campus.
* Senshu University -- one of Japan's leading universities for social
science, Mediasite is being used for capturing video conferencing
between rooms across their several campuses.
* Deloitte Touche Tohmatsu -- one of the four biggest accounting firms
in Japan, it is recording and publishing their payment management
seminars.
* Kao -- one of the leading consumer chemistry and cosmetic companies in
the Far East, Kao is using Mediasite for training and internal
communications.
* SRA -- one of the leading system integration companies in Japan, it is
using Mediasite for internal training and external seminars.
"It is with great excitement and honor that we embark on this partnership with Sonic Foundry," said Yoichi Ozasa, director, Mediasite KK. "After many months of due diligence, research and market feedback, we are confident that this is the right technology to meet a broad range of applications for the rich media market here in Pacific Asia. We look forward to making Mediasite Live as successful here as it already has become in North America."
Mediasite Live is available for immediate delivery in Japan.
About Sonic Foundry®, Inc.
Founded in 1991, Sonic Foundry (Nasdaq: SOFO - News) is a provider of automated rich media communications technology for the enterprise. The company's high-performance rich media presentation systems are trusted by Fortune 500 companies, education institutions and government agencies for a variety of critical communication needs. Sonic Foundry is based in Madison, Wis. For more information about Sonic Foundry, visit the company's Web site at www.sonicfoundry.com
SOFO
Randy, Dew, et al... Have you gentlemen heard of Sonic Foundry in Madison, WI. It my be of interest to some of you "if" your looking to invest in something other than the Biotechnology sector.
Attached with this post is the link to the Shareholder meeting from this last Thursday which I could not attend due to other obligations. Their annual meeting was "captured" using their Mediasite™ product.
http://msite.sonicfoundry.com/mediasite/viewer/?peid=a13b6184-ce03-4313-9693-5dd9af3100af
Cheers and best regards
From marketwatch's wire tonight
Murphy, the editor of Technology Investing newsletter and chief investment officer of his own firm, was the most pessimistic about the near-term prospects for large tech companies. He predicted that 2006 "could be very hard" for Silicon Valley as the current economic recovery gets long in the tooth.
"I think you should be looking for something in health care," Murphy said, although he "likes Oracle as a one-year trading position" in the wake of its PeopleSoft acquisition.
Murphy also said the disconnect between the underlying financial performance of tech firms and the valuations assigned to them by capricious Wall Street investors has been exacerbated lately by the growing influence of hedge funds.
"Hedge funds are probably accounting for half the trading volume these days," Murphy said.
McNamee concurred, adding that the worst thing tech CEO's can do is respond to the short-term demands of investors. On the other hand, executives that stick to their strategic vision, even while thumbing their nose at Wall Street, usually reward their investors over the long term.
He pointed out that Apple Computer CEO Steve Jobs boosted research spending earlier this decade, even as other tech firms were slashing costs to preserve their income statements in the face of plunging stock prices.
That R&D spending push produced the iPod, which has transformed the company (AAPL: news, chart, profile) and driven its stock up more than four-fold in two years, even as Hewlett-Packard (HPQ: news, chart, profile) and other big firms once known for their innovation have languished.
"If you see the management of a company you own responding to Wall Street, sell the stock," McNamee advised.
Still, trying to guess near-term valuations is a fool's game, McNamee said.
_________________________________
http://www.marketwatch.com/news/story.asp?guid=%7B7232D068%2D4D85%2D47FC%2DADAB% 2D2BCA4DDF7EDC%7D&siteid=mktw
FWIW - IMGN
I recently started a position in this company. The following is a nice summary of their current projects.
http://www.immunogen.com/f05_prod.html
Currently, three TAP compounds are in clinical testing: huN901-DM1, developed and owned by ImmunoGen; MLN2704, developed by Millennium Pharmaceuticals, Inc. with our TAP technology; and huMy9-6-DM4 developed by ImmunoGen and licensed to Aventis (now sanofi-aventis). We expect to initiate patient dosing with another TAP compound that is wholly-owned by ImmunoGen – huC242-DM4 – in mid-2005. Additional TAP compounds are in development.
HuN901-DM1 – We developed huN901-DM1 for the treatment of cancers that express the CD56 antigen. These include small-cell lung cancers (SCLC), other cancers of neuroendocrine origin, and certain hematologic malignancies. HuN901-DM1 comprises our huN901 antibody – which targets CD56 – and our DM1 cell-killing agent. ImmunoGen developed and humanized the huN901 antibody, and the huN901-DM1 TAP compound is wholly-owned by us.
Two clinical trials are underway with huN901-DM1 in SCLC: a Phase I/II study with a weekly-dosing schedule and a Phase I study with an accelerated dosing schedule. We plan to report initial findings from the Phase II leg of the Phase I/II study at the American Society of Clinical Oncology (ASCO) annual meeting in May 2005. The findings from the Phase I leg were reported at a previous ASCO: the compound was found to be well tolerated at doses that provide evidence of anticancer activity.
We are in the process of expanding the huN901-DM1 clinical program to include assessment of the compound in CD56-expressing hematological malignancies, or “liquid tumors.” We expect to initiate a clinical trial with huN901-DM1 in multiple myeloma in the spring of 2005.
MLN2704 – Millennium created this TAP compound using a Millennium antibody that targets the prostate-specific membrane antigen (PSMA) and our DM1 cell-killing agent. PSMA is expressed on virtually all prostate cancers. In November 2002, Millennium announced their initiation of Phase I testing with MLN2704, and we announced that we earned a milestone payment with this event. In October 2003, Millennium announced their initiation of a Phase I/II multidose trial with MLN2704. In December 2003, Millennium announced MLN2704 had been granted fast track status by the US FDA, and in March 2004, Millennium announced that the compound had been selected by the FDA for the agency’s Continuous Marketing Application (CMA) Pilot 2 program. Findings from the first MLN2704 study were reported at ASCO in 2004, and Millennium has said that the initial findings from the Phase I/II multidose study are expected to be reported at ASCO in 2005. Requests for information on MLN2704 should be directed to Millennium.
HuMy9-6-DM4 – ImmunoGen created this TAP compound for the treatment of acute myeloid leukemia. It comprises our huMy9-6 antibody – which targets CD33 – and our DM4 cell-killing agent. We licensed this compound to Aventis from our preclinical portfolio as part of a broader collaboration between the two companies. Aventis subsequently became sanofi-aventis, and in March 2005, sanofi-aventis advanced huMy9-6-DM4 into clinical testing. We earned a $2 million milestone payment with their initiation of clinical testing.
HuC242-DM4 – We created huC242-DM4 for the treatment of cancers that express the CanAg antigen. These include colorectal, pancreatic, and other gastrointestinal cancers, as well as many non-small-cell lung cancers. HuC242-DM4 comprises our huC242 antibody, which targets CanAg, and our DM4 cell-killing agent. The compound is wholly-owned by ImmunoGen. We expect to begin Phase I clinical testing with huC242-DM4 in mid-2005.
An earlier version of this compound – cantuzumab mertansine (huC242-DM1) – was advanced into clinical testing by SmithKline Beecham (now GlaxoSmithKline). In Phase I studies, cantuzumab mertansine was found to be well tolerated and to demonstrate evidence of anticancer activity. Once we re-gained all of our product rights from GlaxoSmithKline, we tested cantuzumab mertansine against alternative product designs, including huC242-DM4, in multiple preclinical models. We concluded that huC242-DM4 was the best product design for this antibody and antigen, and thus are advancing huC242-DM4.
Other compounds in preclinical development – These include: an anti-IGF-IR antibody and a TAP compound for B-cell malignancies that we licensed to Aventis as part of our broader collaboration; a TAP compound comprising Genentech’s trastuzumab (Herceptin®) antibody and our DM1; and TAP compounds in development by Biogen Idec and by Centocor to undisclosed targets.
New diabetic drug class shows promise
http://www.drugresearcher.com/news/news-ng.asp?n=58974-new-diabetic-drug
24/03/2005 - Canadian biopharmaceutical company, Theratechnologies, has announced positive results for its latest drug candidate for the treatment of type II diabetes. The GLP-1 analogue takes its position in a market for this rapidly evolving new class of drugs.
The news of a novel class of drugs that treats type II diabetic patients is good news for sufferers that have had to put up with treatments and therapies that have unpleasant side effects.
GLP-1, a hormone produced in the intestine, induces insulin secretion in a glucose dependent manner, controls gastric emptying and inhibits food intake as well as glucagon and somatostatin secretion. The natural GLP-1 molecule rapidly degrades in the blood and, therefore, needs to be stabilised to be clinically useful. Clinical studies in type 2 diabetes patients have confirmed the therapeutic potential of GLP-1 analogues.
The phase I study was to demonstrate the safety of the candidate TH0318 and consisted of 36 healthy male volunteers, aged 18 to 45, divided into 6 groups. TH0318 was administered by subcutaneous injection and the dose level was raised in sequential groups.
Overall, the safety profile of the treated population was similar to placebo and, at all doses, there were no cases of nausea, which is a common side effect of GLP-1 therapy. Dose-related pharmacokinetics was noted across the entire dose range. At the higher doses tested, pharmacodynamic effects (decreased blood glucose levels) were also noted.
"TH0318 is only one compound in our portfolio of GLP-1 analogues that lends itself to several interesting alternatives in terms of dosing intervals and delivery systems," said Yves Rosconi, president and chief executive officer of theratechnologies.
Currently there are six classes of approved oral agents, each of which works through a different mechanism. An estimated 5.9 million patients are taking oral therapy in the United States. Eventually, many patients require insulin therapy. Oral agents are also used with insulin therapy. It is estimated that currently, over 3.5 million patients in the United States are on insulin therapy.
Type 2 diabetes mellitus generally occurs after age 40 and is the most common form of diabetes. Patients suffer from insulin resistance or insufficient production of insulin, a hormone that allows glucose (sugar) to enter cells and be converted into energy. Diabetes often leads to severe complications, including heart disease, stroke, blindness, kidney disease, nerve damage, and ultimately premature death.
Diabetes, which has many treatments but no definitive cure, is approaching epidemic status, increasing at three times the rate of the population growth in North America. There are an estimated 18 million people in the United States suffering from diabetes and another 41 million have pre-diabetic conditions that put them at risk. The aging population, sedentary life styles, and obesity are contributing to the rapid expansion of the diabetic population.
Sulfonylureas are the oldest class, and they work by increasing insulin secretion. These agents work only when there is sufficient insulin producing B-cells in the pancreas. Commonly used sulfonylureas include short acting agent, Tolbutamide, intermediate acting agents, Gilpizide and Glicazide, and long acting agents, Chlorpropamide, Glyburide and Climepiride.
The Meglitinides act like the sulfonylureas in that they stimulate insulin secretion. However, they bind to different receptors and are generally more rapidly absorbed and cleared. There are two only commercially available meglitinides: NovoNordisk’s Repaglinide (Prandin) and Novartis’ Nateglinide (Starlix).
The Biguanide class features one main compound, Metformin, sold by Bristol-Myers Squibb, and is now available in generic form by a range of suppliers. Metformin increases insulin activity but does not impact pancreatic beta cells. A central activity of Metformin is to lower glucose production by the liver by potentiating insulin activity.
The class of (alpha)-glucosidase inhibitors has acarbose as the main agent in this category. The (alpha)-glucosidase inhibitors work by breaking down oligosccharides into monosaccharides in the small intestine, thereby lowering post-meal (prandial) glucose and delaying glucose absorption.
Thiazolidinediones are the newest class of diabetic drugs and are broadly thought of as insulin potentiating agents or insulin sensitisers. This class of agents includes GlaxoSmithKline’s rosiglitazone (Avandia) and Takeda’s piglitazone (Actos). The thiazolidinediones work through a receptor called the PPARy receptor, which regulates transcription factors for genes involved in insulin action and lipid metabolism.
These agents are thought to enhance insulin’s ability to cause glucose uptake in muscle tissue. The thiazolidinediones have also demonstrated postive effects on plasma lipids, including raising HDL and lowering LDL cholesterol. The first approved thiazolidinedione was Warner Lambert’s Rezulin, which was removed from the market due to high liver toxicity. However liver toxicity is believed to be attributable only to Rezulin, and is not thought to be a class effect. Side effects that are more common to the class include weight gain, fluid retention and mild general swelling.
Biowatch - GTCB
Biowatch - Thank you for sharing your telephone conversation with Mr Newberry of GTCB. This group of individuals (DD, Biowatch, Urche, PGS, Drbio45, Randy, mskatie, walldiver & others) are truly a cool bunch of people that like to share ideas and opinions. I have learned much and wish to express my thanks to all of you. Makes every other BB weak in comparison.
Ok..Now back to regular programing.
Good investing to you all!
b.rgds