Question: What is the bodies normal Defense of C. Diff Colonization?
Answer: Healthy people can carry this harmful bacteria but not every is affected by it. Those who have an Abundance of Good Protective Bacteria in our Gut has a much greater chance of not becoming ill. This doesn’t necessarily mean that these healthy carriers are eradicated from the C. Diff, but their healthy gut micro - biome is enough to defend them from becoming ill. When they become older that is another thing. The healthy gut microbiome prevents the colonization of C.Diff. The good bacteria and the byproducts of them protects the gut from C. Diff spreading and developing a comfortable home to reproduce. Although…once the microbiome is Compromised, then C. Diff has a likelihood of colonization.
Question: How do Antibiotics Disrupt the Microbiome?
Answer: Antibiotics kill off all bacteria…good and bad. Antibiotics also can cause diarrhea but that doesn’t mean the patient has C. Diff. 1. C. diff exposure --- can occur with a C. Diff carrier, a hospitalization, nursing home stay, or environmental contact with the spores increase the risk. 2. Immune Compromise – patients over 65, patients with chronic disease and patients with comorbidities have a much greater chance of C. Diff exposure. 3. Antibiotic Exposure --- Disruption of the microbiome can lead to C. Diff colonization. Dr. Wilcox from SYN says that Antibiotic use can weaken the immune system up to 3 months after use for contacting C. Diff. Also - Cumulative antibiotic exposure and how many different antibiotics are used increases the chances of acquiring C. Diff. So the more antibiotics received, the higher the risk.
Question: Do All antibiotics prevent the SAME risk for C. Diff infection?
Answer: The answer is NO --- 4 Antibiotic Classes are Known to have a higher risk: These classes are: 1. Clindamycin 2. Beta Lactams --- specifically the penicillins and the cephlasporins and lastly 3. FluoroQuinolone Class
Question: Should Physicians curb their use of antibiotics?
Answer: The over use of antibiotics have led to Superbugs like Methicillin-resistant Staphylococcus aureus (MRSA), Carbapenem-resistant enterobacteriaceae (CRE), and C. Difficile. Unfortunately we have to treat life threatening diseases with antibiotics…especially Pneumonias. SYN-004 may provide protection from these superbugs when patients are receiving some of these antibiotics.
Question: Why do some patients experience Recurrence C. Diff infections?
Answer: As Counterintuitive as it sounds…CDI’s are treated with more Antibiotics. They are treated with Narrow Spectrum antibiotics and these often lead to Further Microbiome Destruction. So up to 30% of C. Diff sufferers experience a recurrence. Recurrence occurs because of one of these factors: 1. The infection was not completely eradicated. 2. There are spores which are difficult to kill and these Spores eventually will grow after they sense no harmful antibiotic. 3. The patient is infected with a Mutated Strain of C. Diff. The key to preventing C. Diff is to Preserve the Gut Microbiome in the First place.
Note: End of the segment with Lewis Barrett.
Now Dr. Joseph Sliman will come in and talk about SYN-004
Question: Dr. Sliman…would you like to start by saying anything?
Answer: The Prevention of C. Diff is a Major Clinical Need. In 2012 there were 1.1 Million patients released from hospitals with the C. Diff infection. If we site the CDC --- C. Diff was responsible for almost ½ Million infections and associated with approximately 29,000 deaths in 2011 alone. This is data from the February 26th, 2015 NEJM edition. C. Diff is highly prevalent and physicians need realize this and Utilize Strategies to prevent colonization’s of C. Diff in the first place and especially colonization of toxin producing Strains of C. Diff. We believe we can play a part in this prevention in the people at risk with our product SYN-004.
Question: Can you continue to explain how SYN-004 can prevent C. Diff?
Answer: Dr. Sliman now defines some biological terms: The Gut…so when we say the gut, technically we are referring to the stomach and the intestines. The gut microbiome is mostly living in the intestinal system. There are approximately 100 Trillion microorganisms make up our microbiome. Now the healthy microbiome prevents pathologic infections such as C. diff by what we call the “Barrier Effect” or the “Protective Barrier”. Within this barrier there is competition for nutrition. Now the Nutrient Absorption occurs in the Small Intestine and there are approximately 1 Million microorganisms per Milliliter. The final part of the small intestine is called the Ileum and this is the section where most food absorption takes place. Now all unabsorbed matter or antibiotics goes through the ileum and into the large intestine (colon) to be passed as waste. In the Ileum the bacterial concentration count is approximation 1 to 10 million microorganisms per milliliter. Then we get to the Colon and this is where most of the water and mineral absorption takes place. The bacterial concentration in the colon is about 100 Billion to 1 Trillion microorganisms per milliliter of fluid.
Question: How does SYN-004 work to protect the microbiome?
Answer: SYN-004 is Unique. It is a first in class product candidate that is currently in clinical trials that is intended to protect the Gut Microbiome and the Prevention of C. Diff infection. It is projected that SYN-004 will be given Concurrently with IV antibiotics --- specifically Penicillin’s and Cephalosporin’s . The active ingredient will stay in the intestinal trace where it is expected to inactivate the mentioned antibiotics above that are secreted in the gut. Since these particular antibiotics are being inactivated in the gut it should prevent any colonization of C. Diff by protecting the healthy microbiome.
Question: How can our listeners become involved in C. Diff clinical trials?
Answer: The upcoming Clinical Trials are expected to be Conducted around Multiple sites around the Globe. These trial sites are obligated to adhere to strict clinical protocols by the FDA. Investigators may invite Qualified patients to participate in clinical trials after informed consent is signed by patients. It is important to remember that any clinical trial participant can withdraw the clinical trial at any given point.
Question: Since 30% of patients experience Recurrence of C. Dif --- Are these patients qualified to participate in SYN-004 clinical trials?
Answer: The upcoming Phase II Clinical Studies include all Hospitalized patients receiving the IV antibiotics that SYN-004 is intended to treat. They will be given SYN-004 to see if the drug prevents C. Diff.
Question: We have heard about Fecal Microbiota Transplants or FMT’s and the success it has had in prevention. How is this different in how SYN-004 works?
Answer: Both treatments have the same objective of targeting the microbiome. SYN-004 is designed to prevent the patient from EVER getting C. Diff in the first place. FMT is used after a person has been infected with C. Diff. FMT’s objective is to Re-establish microbiome good bacterial and SYN-004 is to PROTECT the microbiome barrier from ever being damaged. Also in FMT treatment, if the patient ever has another round of antibiotics they are still susceptible to C. Diff. SYN-004 once again is a preventative measure so one will never acquire C. Diff in the first place and thus will never have to be treated for it.
The IMF has a lot of influence on this as they want our dollar not to get too strong.
Now it's a time for Weeding out the weeds.
SYN is not a weed and this is just a ploy to accumulate cheap shares.
Syn remains one of the most manipulated stocks I have ever invested in. It can be manipulated at the will of hedgies anytime of any day and this is what stinks.
Now: Before this will rise...watch a continuation of lower volume before the shorts realize that the bulls will not allow for any more of their manipulation.
They have brought it down over $1 in a short period of time. When they realize that they milked this cow as long as they possible could, the volume will slow down--- which is a short period of indecision and then also with this lower volume in coming days they will cover and go the other way.
As you say DQ.... Rinse and Repeat.
It is getting close, maybe next week at this time it will begin to reverse.
They wouldn't allow me to keep copying and pasting page after page from Works.
I put it on a blog at: https://molley2009.wordpress.com/2015/04/
Or you can Google Biopharm Stock Picks and look in April 2015 category if that link above doesn't work.
Which yahoo may not even allow that link.
Question: SYN-004 works on Beta Lactams…what about Clindamycin’s and Fluoroquinolone’s?
Answer: SYN-004 does NOT exhibit any activity agains Clindamycin’s or fluoroquinolones, it is not designed to protect against these particular class of antibiotics. For the record, 60% are receiving Beta Lactams right now and if SYN-004 is approved it could guide more physicians to use the Beta Lactams…especially for the at Risk patients described above.
Question: Antibiotic Exposure is a risk of developing C. Diff infection. I (Nancy) would think that patients would be at risk more with Oral Antibiotics rather than IV antibiotics. Why did you develop it for IV and not oral?
Answer: The most serious cases of antibiotic use is in the hospital setting treating with IV antibiotics. MORE than 70% of C. Diff infections are Hospital Acquired it was LOGICAL to start with IV antibiotics. ***Synthetic Biologics DOES plan on developing products that target Oral Antibiotics.
Question: Earlier you said that SYN-004 target antibiotics, could you please name them for us?
Answer: Sure: SYN-004 has shown activity against cephalosporins and penicillins the beta lactam class. So in the Penicillin Family include: Ampicillin, Piperacillin and piperacillin tazobactam. In the Cephalosporin Family include: Cephtriaxone, Cefepime, Cefixime, Cefazolin, Cefoperazone and Cefuroxime.
I will do my best to get this in order:
Lewis Barrett and Dr. Joseph Sliman
First up: Lewis Barrett of Synthetic Biologics –Senior Vice President , Commercial Strategy --- C Diff Infection or CDI is the leading cause of hospitalized infections in the U.S. today. It is right now being targeted the U.S Centers for Disease Control, FDA and European Health Authorities.
NEJM or New England Journal of Medicine studied C.Diff and projected that nearly ½ Million Americans suffered from CDI. 100,000 C. Diff infections occurred at U.S. nursing homes post release from hospital. There were up to 30,000 CDI related deaths in the U.S. 1 out of 5 CDI infected patients experienced a recurrence.
C. Diff is transmitted by Spores and these spores can be on the surfaces on anything in the hospital including medical equipment. These spores can stick to the hands--- be released on patients and they can be infected. The spores are very difficult to kill on the surfaces and on the medical equipment.
Question: What are some of the Risk Factors for Developing a CDI?
Answer: There are several risk factors. A. Recent antibiotic use…these patients have a 7 to 10 fold increase of developing C. Diff infection. B. The Elderly---about 2/3rds of all CDI’s occur in patients over 65. C. Those who have had or have a chronic illness and co-morbidities ---including immunosuppression, kidney disease and cancer. D. A recent stay at a hospital or a nursing home --- this is where the majority of the spores are. E. About 20% of hospitalized people are estimated to be a Carrier of C. Diff and up to 50% in long term care facilities are believed to be Carriers of the C. Diff Spores. So you can get an idea of why the CDC, FDA and European Health Authorities are seriously worried about this.
I do agree with that...now that the stock has took a good dive, you have to begin evaluation at lower PV's, but Success_Now is on to something....I've been studying this for other stocks and have actually made some good money from his advice only to lose it all on a Stupid bet on buying CUR too high.
Sometimes when I have something in mind that I want to buy -- I make DUMB VERY costly mistakes.
No more...buy LOW.
This is from a few CC's ago. It is all accurate as to what Riley says.
It ALL is in the court of Dr. Voskuhl and when she has completed her evaluation of her MRI data as I'm sure potential buyers want to see.
Those partnering options mentioned above are just about exactly what Riley has said he has already talked about with potential partners (at least that is what he indicated).
The true future of this stock is with C. Diff and IBS-C, but don't discount the Purtussis Whooping Cough Monoclonal antibody combination...even though it is behind, it could save a LOT of lives and that one could be a "Sleeper" down the road...not so much in America but the World is finally putting out cash to help the poor countries. We likely won't get top dollar for it outside the U.S. but I do believe there will be a market for it and SYN will make profits.
Yes Don Q you are right. I am not implying that anyone SELL, I am implying that this is a buying opportunity for people who are planning on holding as I believe they will be rewarded big time.
I think that the recent new patent adds a lot of value. I'm not clear on if they are waiting for other patents or if they believe this is efficient for a great deal.
I'm not sure who is giving the thumbs down, it appears we have a lot of shorts on this board and that usually means ACCUMULATION through MANIPULATION.
So don't be duped by these guys.
No I have written copies of both of them and they occurred within three days of each other.
My friend Scott C whom I have the greatest respect for--- a guy on the first conference call asked CEO Riley when partnership could be announced and he said in June.
Then on the next conference call he revised that Dr. V's data could be in by Mid Year. This is the Kicker --- Mid Year. This is the set back that could cause the partnership set back and once again, why I believe the shorts are attempting to take out stops and run this as low as they can and then this will REALLY begin to run UP.
Now Mid Year is June --- Now if it is in the first part of June then partnership could be announced by June...But on the Second...the most up to date Conference call Riley said at 12:53 into the conference call that they plan to partner "Sometime this Year". Earlier he said he "ANTICIPATES" Top Line MRI Results by Mid Year.
Like I said: Mid Year is likely June and I would NOT expect a deal to be accomplished before these results...and would assuming take about a month after the MRI's to come to a final settlement on a partnership.
I assume that we are being downgraded because of these "subtle" changes in the projected timeline.
This have given investors one heck of a deal at this low of market cap.
Riley two conference calls ago said "Shareholders are going to be rewarded" this year. I know he knows many are still holding shares WELL over $3 so I would surmise Well Rewarded would mean $6 or more...that is just my opinion.
It's tough to be patient...you either are in it 100% or you are not.
I believe 100% and have followed SYN very closely for over a year now (not long, but I do my research).
Let's see how tomorrow goes, that should be the true tell if the bottom is in or not. They may play around with this the rest of the week.
Daily Double bottoms or Tweezers can be a sign. I hope this is a tweezer.
You just informed everyone of you intelligence if you believe in Zacks and Maxim...especially Maxim
Sanofi has a Vaccine that is in Phase III to prevent C. Diff but I have to research more about this one.
That said Liz: I believe that ours will be used in combination because nothing is a 100% sure shot. Either way...SYN-0004 will raise our value significantly